Phase 2 Study Evaluating the Efficacy of the Combination of DKN-01 (DKK1 Inhibitor, Leap Therapeutics) and Pembrolizumab in the Treatment of Advanced or Recurrent Endometrial Cancer

To learn if the combination of DKN-01 and pembrolizumab can help to control advanced or recurrent endometrial cancer.

Start Date29 Aug 2023

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+3]

NCT05480306

/ Active, not recruitingPhase 2

Randomized Phase 2 Study of DKN-01 Plus FOLFIRI/FOLFOX and Bevacizumab Versus FOLFIRI/FOLFOX and Bevacizumab as Second-line Treatment of Advanced Colorectal Cancer (DeFianCe)

This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) [FOLFIRI/FOLFOX and bevacizumab] as second-line treatment of advanced CRC patients.

Start Date30 Aug 2022

Sponsor / Collaborator

Leap Therapeutics, Inc.

NCT04363801

/ Active, not recruitingPhase 2

A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients With Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)

A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Start Date29 Jul 2020

Sponsor / Collaborator

Leap Therapeutics, Inc.

[+1]

100 Clinical Results associated with Sirexatamab

100 Translational Medicine associated with Sirexatamab

100 Patents (Medical) associated with Sirexatamab

Literatures (Medical) associated with Sirexatamab

01 Feb 2025·APPLIED BIOCHEMISTRY AND BIOTECHNOLOGY

DKN-01 Suppresses Gastric Cancer Progression Through Activating cGAS-STING Pathway to Block Macrophage M2 Polarization

Article

Author: Qi, Yingying ; Wang, Sisi ; Yang, Xiaohuan

Dickkopf-1 (DKK1) is a secretory antagonist that can bind with the Wnt coreceptor to desensitize cells to canonical Wnt ligands. DKN-01 is a specific antibody targeting secreted DKK1, which has been investigated as a monotherapy or combination therapy for various malignant tumors, including gastric cancer (GC). Tumor-associated macrophages (TAMs) with high plasticity usually present M2 phenotype, which can promote tumor progression. The aim of this study was to investigate the effect of DKN-01 on macrophage polarization in GC and the underlying molecular mechanism. To ascertain the effect of DKN-01 on GC tumor growth, we established a tumor-bearing mouse model and found that DKN-01 treatment suppressed tumor growth efficiently. Through RNA-seq and pathway enrichment analysis, we identified that the differentially expressed genes after DKN-01 treatment are associated with tumor immune-related pathways. Macrophage polarization was assessed using immunohistochemistry and quantitative real-time polymerase chain reaction. DKN-01 and knockdown of DKK1 promoted M1 polarization and inhibited M2 polarization of macrophages, while DKK1 overexpression got the opposite results. Moreover, DKN-01 activated the cGAS/STING pathway, while the inactivation of cGAS-STING pathway using RU.521 reversed the inhibition of tumor growth in vivo and macrophage M2 polarization caused by DKN-01. This study reveals that DKN-01 suppresses GC tumor growth through activating cGAS-STING pathway to block macrophage M2 polarization.

20 Jan 2025·JOURNAL OF CLINICAL ONCOLOGY

DKN-01 in Combination With Tislelizumab and Chemotherapy as First-Line Therapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: DisTinGuish

Article

Author: Stilian, Melissa C. ; Thoma, Mathis ; Ajani, Jaffer A. ; Scott, Aaron James ; Chung, Vincent ; Chiu, Vi K. ; Kagey, Michael H. ; Uronis, Hope Elizabeth ; Tejani, Mohamedtaki Abdulaziz ; Baum, Jason ; Sirard, Cynthia A. ; Sonbol, Mohamad Bassam ; Wainberg, Zev A. ; Iqbal, Syma ; Altura, Rachel A. ; Zhang, Ying ; Klempner, Samuel J.

PURPOSE:

The outcomes of anti–PD-1 agents plus fluoropyrimidine/platinum in frontline advanced gastroesophageal adenocarcinomas (aGEAs) remain poor. We investigated the safety, tolerability, and activity of fluoropyrimidine/oxaliplatin and tislelizumab with the DKK1-neutralizing antibody DKN-01 in aGEAs in a phase IIa open-label study.

PATIENTS AND METHODS:

Patients had untreated human epidermal growth factor receptor 2–negative aGEAs, RECIST v1.1 measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate organ function. Patients received intravenous DKN-01 300 mg once every 2 weeks, tislelizumab 200 mg once every 3 weeks, oxaliplatin 130 mg/m 2 once every 3 weeks, and capecitabine 1,000 mg/m 2 twice daily on days 1-15 of each 21-day cycle. The primary end point was safety and tolerability. Key secondary end points included objective response rate (ORR) by RECISTv1.1, progression-free survival (PFS), and overall survival (OS).

RESULTS:

Between September 18, 2020, and April 8, 2021, 25 patients were enrolled. All patients who received at least one dose of DKN-01 were included in the safety analysis. Most patients had gastroesophageal junction tumors, median age was 61 years, 76% were male, and 55% were ECOG of 0. All patients reported at least one treatment-emergent adverse event. The ORR was 73% (95% CI, 49.8 to 89.3), with a disease control rate of 95%. The ORR was 90% (95% CI, 55.5 to 99.7) in the DKK1-high tumor patients and 67% (95% CI, 29.9 to 92.5) in the DKK1-low tumor patients. The median PFS was 11.3 months (95% CI, 5.8 to 12.0) and the 12-month PFS rate was 33%. The median OS was 19.5 months (95% CI, 15.2 to 24.4) with a 12-month OS rate of 76% and an 18-month OS rate of 55%.

CONCLUSION:

DKN-01 can be safely combined with frontline fluoropyrimidine/oxaliplatin and tislelizumab and demonstrates encouraging activity independent of PD-L1 expression levels. A randomized phase II trial is ongoing (ClinicalTrials.gov identifier: NCT04363801 ).

01 Jun 2024·Hematology/oncology clinics of North America

Targeted Agents in Esophagogastric Cancer Beyond Human Epidermal Growth Factor Receptor-2

Review

Author: Mehlhaff, Eric ; Miller, Devon ; Ebben, Johnathan D ; Uboha, Nataliya V ; Dobrzhanskyi, Oleksii

Gastroesophageal cancers are highly diverse tumors in terms of their anatomic and molecular characteristics, making drug development challenging. Recent advancements in understanding the molecular profiles of these cancers have led to the identification of several new biomarkers. Ongoing clinical trials are investigating new targeted agents with promising results. CLDN18.2 has emerged as a biomarker with established activity of associated targeted therapies. Other targeted agents, such as bemarituzumab and DKN-01, are under active investigation. As new agents are incorporated into the treatment continuum, the questions of biomarker overlap, tumor heterogeneity, and toxicity management will need to be addressed.

News (Medical) associated with Sirexatamab

26 Mar 2025

·www.prnewswire.com

Leap Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results

Leap to host a conference call to present updated CRC clinical data today, March 26, 2025, at 8:00 a.m. ET CAMBRIDGE, Mass., March 26, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2024. Leap Highlights: Reported positive updated data from Part B of the Phase 2 DeFianCe study of sirexatamab (DKN-01) in second-line patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) confirming: Statistically significant 32% higher overall response rate (ORR), 3.5 month longer progression-free survival (PFS), and longer overall survival (OS) in patients with high DKK1 levels Statistically significant 22% higher ORR and 2.6 month longer PFS in patients who had not had prior anti-VEGF therapy FL-501 abstract accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting. "In 2024, we continued to advance sirexatamab, our anti-DKK1 antibody, through Phase 2 randomized controlled clinical trials as part of our mission to bring personalized medicines to patients fighting against cancer. In particular, the updated data from Part B of the DeFianCe study that we announced today demonstrated significantly higher ORR and longer PFS for sirexatamab in patients who have high levels of DKK1 or who have not had prior anti-VEGF therapy, two exploratory populations with strong scientific rationale that each represent 25-50% of the second-line CRC market," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We believe that there is a compelling opportunity to move forward with a registrational study for sirexatamab in patients with CRC and to advance FL-501 towards clinical trials." DKN-01 Development Update Reported updated clinical data from Part B of the DeFianCe Study of sirexatamab plus bevacizumab and chemotherapy in CRC patients. Today, the Company announced updated preliminary data from Part B of the DeFianCe study (NCT05480306), a Phase 2, open-label, global study of sirexatamab in combination with bevacizumab and chemotherapy (Experimental Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with MSS CRC who have received one prior systemic therapy for advanced disease. In the updated data announced today, Patients with high DKK1 levels, either at the upper quartile or above the median, treated in the sirexatamab Experimental Arm had significantly improved ORR, PFS, and OS compared to the Control Arm. In patients who had not received prior anti-VEGF therapy, the sirexatamab Experimental Arm had significantly improved ORR and PFS compared to the Control Arm, with an early advantage in OS. Across the intent-to-treat population, the sirexatamab Experimental Arm had improved ORR compared to the Control Arm, with PFS and OS maturing with a higher number of patients continuing to benefit on the sirexatamab Experimental Arm. The strong signal from the DeFianCe study supports a registrational Phase 3 clinical trial to evaluate sirexatamab plus bevacizumab and chemotherapy in second-line MSS CRC patients with high DKK1 levels or in patients who have not received prior anti-VEGF therapy. With approximately 30,000 second-line treated CRC patients in the US and 160,000 in the next 7 largest markets, sirexatamab has a large market opportunity in the 25-50% of patients who have high DKK1 levels or in the approximately 50% of patients who did not receive prior anti-VEGF therapy. In addition, the outcomes in patients with no prior anti-VEGF therapy provides an opportunity to move into treating first-line CRC patients, where there are an estimated 45,000 patients in the US and 265,000 in the next 7 largest markets who receive therapy for their advanced disease. Leap has engaged a leading financial advisor to explore business development opportunities to further the development of sirexatamab. Pipeline Update Presenting preclinical FL-501 data at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Preclinical data from FL-501, a potential best-in-class monoclonal antibody designed to neutralize GDF-15 to treat patients with cachexia and other GDF-15-driven diseases, will be featured during a poster session at the 2025 AACR Annual Meeting taking place April 25-30 in Chicago. In addition, manufacturing and non-clinical development continues with the goal of beginning a clinical trial in 2026. Conference Call Leap's management team will host a conference call today, March 26, 2025 at 8:00 a.m. Eastern Time to further discuss the data. The conference call will be broadcast live in listen-only mode and can be accessed via the webcast URL: . A replay of the event will be available for a limited time on the Investors page of the Company's website at . Selected Year-End and Fourth Quarter 2024 Financial Results Net Loss was $67.6 million for the year ended December 31, 2024, compared to $81.4 million for the year ended December 31, 2023. The decrease was primarily due to a decrease in research and development expenses. Research and development expenses were $57.2 million for the full year 2024, compared to $73.2 million for the same period in 2023. Research and development expenses were $13.1 million for the fourth quarter ended 2024, compared to $11.7 million for the same period in 2023. The decreases for the full year 2024 were primarily due to in-process research and development acquired in the Flame merger which were expensed in the year ended December 31, 2023. General and administrative expenses were $12.8 million for the full year 2024, compared to $13.8 million for the same period in 2023. General and administrative expenses were $3.0 million for the fourth quarter ended 2024, compared to $3.1 million for the same period in 2023. The decreases for the full year 2024 were primarily due to a decrease in professional fees due to lower finance and legal costs. Cash and cash equivalents totaled $47.2 million at December 31, 2024. About Leap Therapeutics Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Sirexatamab is being studied in patients with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via . FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the size of the potential addressable market for sirexatamab, including the number or percentage of patients with advanced CRC that have or are likely to have high levels of DKK1 or that have not had or are likely not to have prior anti-VEGF therapy; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) the results of Leap's clinical trials and pre-clinical studies, including whether the final data from Part B of the DeFianCe study or Part C of the DisTinGuish study are the same as the initial data reported, (ii) the actual size of the potential addressable market for sirexatamab, including the number or percentage of patients with advanced CRC that have or are likely to have high levels of DKK1 or that have not had or are likely not to have prior anti-VEGF therapy, may be smaller than estimated, (iii) Leap's ability to successfully finance or enter into new strategic partnerships for sirexatamab or any of its other programs; (iv) any regulatory feedback that Leap may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency with respect to the registrational Phase III clinical trials that Leap proposes to conduct using sirexatamab for the treatment of patients with second-line CRC or with respect to any other pre-clinical or clinical development activities that Leap will be required to conduct in order to obtain regulatory approval of sirexatamab for the treatment of second-line CRC; (v) whether any Leap products will receive approval from the FDA or equivalent foreign regulatory agencies; and (vi) exposure to inflation and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. Onsi President & Chief Executive Officer Leap Therapeutics, Inc. 617-714-0360 [email protected] Matthew DeYoung Investor Relations Argot Partners 212-600-1902 [email protected] SOURCE Leap Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultPhase 3Financial Statement

26 Mar 2025

·endpts.com

Humacyte to raise $50M; Acrivon to focus on prexasertib in endometrial cancer

Plus, news about Tribune Therapeutics and Leap Therapeutics: Humacyte’s $50M offering: The North Carolina biotech is selling 25 million shares at $2.00 apiece, which is nearly 30% lower than its closing price on Tuesday. The shares $HUMA were down 25% on Wednesday morning. The FDA approved the company’s lab-grown blood vessels in December. A New York Times report earlier this week found the agency greenlit the product despite concerns from its reviewers. — Kyle LaHucik Acrivon shrinks ambitions for former Eli Lilly drug: The biotech “officially deprioritized” a former Eli Lilly asset called prexasertib, or ACR-368, in ovarian and bladder cancer. The Boston-area biotech is “reallocating all clinical resources” for the drug in endometrial cancer, per an SEC filing . Acrivon had raised $130 million in a PIPE last April. Its shares $ACRV were down about 30% on Wednesday morning. — Kyle LaHucik Tribune Therapeutics’ $40M debut: The biotech launched with seed and Series A funds from LifeArc Ventures, Novo Holdings and others. It plans to use the funding to test its new treatment candidates for fibrosis, or scarring, in the lung, kidney, liver and other areas. Tribune’s drug candidate, TRX-44, is aimed at treating patients with idiopathic pulmonary fibrosis. The financing will “prepare” the startup to conduct human studies of the experimental medicine. — Kyle LaHucik What’s next for Leap Therapeutics’ sirexatamab: The biotech said it’s working with a financial advisor to “explore business development opportunities” for sirexatamab, an anti-DKK1 monoclonal antibody. The Cambridge, MA-based biotech is testing the drug candidate in forms of colorectal and gastric cancers. — Kyle LaHucik

Drug ApprovalIPO

28 Jan 2025

·www.fiercebiotech.com

Leap crashes as midphase data mark end of gastric cancer program

Leap decided to focus on colorectal cancer and drop plans to run a gastric cancer phase 3.\n Leap Therapeutics has come crashing down to earth. The biotech axed plans to advance into phase 3 in gastric cancer on the basis of midstage data, sending its stock down 60% to below $1, but it is forging ahead in another indication.Massachusetts-based Leap made the decisions after seeing data from two parts of a phase 2b trial of its anti-DKK1 antibody sirexatamab. The biotech reported a 35% response rate in colorectal cancer patients who received sirexatamab, bevacizumab and chemotherapy, compared to 23% in the active control arm.After an average of six months of follow-up, Leap saw signs of improved progression-free survival (PFS) in some subgroups. The signs are yet to translate into a statistically significant improvement in PFS and the number of PFS events is evenly balanced between the experimental and control arms, with 37 and 38, respectively. More people, 46, are still on the study drug than the control, 36.Leap said the “strong signal” supports taking the drug combination into a registrational phase 3 trial in second-line patients. The biotech saw higher response rates in some subgroups and will decide on the optimal population for the phase 3 as the data mature. That is as good as it got for Leap. The other part of the study assessed the effect of adding sirexatamab to tislelizumab, BeiGene\'s anti-PD-1 antibody, and chemotherapy in first-line advanced gastroesophageal junction and gastric cancer patients.The combination improved confirmed response rates in the intent-to-treat population and subgroups of PD-L1 negative patients by blinded independent central review (BICR). However, “there was a high level of discordance between investigator assessment and BICR,” Cynthia Sirard, M.D., chief medical officer at Leap, said in a statement. The trial will be negative on the PFS endpoints when it completes, Leap said.Based on the results, Leap decided to focus on colorectal cancer and drop plans to run a gastric cancer phase 3. Sirard said Leap will “explore strategic partnership opportunities to advance sirexatamab plus anti-PD-1 antibodies in gastric cancer and other indications where there is high DKK1 expression.” Leap CEO Douglas Onsi compared the colorectal and gastric opportunities at a Piper Sandler event last month, where he said “every single pharmaceutical company know[s] it is a very substantial U. S. and European market, and stands on its own.” “Gastric cancer is important to some companies and not to others,” Onsi added at the December event. “I think people look at the gastric opportunity as a PD-1 combination opportunity and the opportunity to take it beyond gastric to other PD-1 combinations.”

Phase 3Clinical ResultPhase 2

100 Deals associated with Sirexatamab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of large intestine	Phase 2	United States	Leap Therapeutics, Inc.	30 Aug 2022
Adenocarcinoma of large intestine	Phase 2	Germany	Leap Therapeutics, Inc.	30 Aug 2022
Advanced Colorectal Adenocarcinoma	Phase 2	United States	Leap Therapeutics, Inc.	30 Aug 2022
Advanced Colorectal Adenocarcinoma	Phase 2	Germany	Leap Therapeutics, Inc.	30 Aug 2022
Gastroesophageal junction adenocarcinoma	Phase 2	United States	BeiGene Ltd.	29 Jul 2020
Gastroesophageal junction adenocarcinoma	Phase 2	United States	Leap Therapeutics, Inc.	29 Jul 2020
Gastroesophageal junction adenocarcinoma	Phase 2	Germany	BeiGene Ltd.	29 Jul 2020
Gastroesophageal junction adenocarcinoma	Phase 2	Germany	Leap Therapeutics, Inc.	29 Jul 2020
Gastroesophageal junction adenocarcinoma	Phase 2	South Korea	Leap Therapeutics, Inc.	29 Jul 2020
Gastroesophageal junction adenocarcinoma	Phase 2	South Korea	BeiGene Ltd.	29 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05480306 (DeFianCe, Company_Website) Manual	Phase 2	Colorectal Cancer Second line DKK1 Expression \| Microsatellite Stable (MSS)	188	Sirexatamab + bevacizumab + chemotherapy (high DKK1 levels)	pskuctccqj(ertqecntoc) = cggunizdps crczxrtpml (zsiuhjtzcj ) View more	Positive	26 Mar 2025
				bevacizumab + chemotherapy (high DKK1 levels)	pskuctccqj(ertqecntoc) = pdhudlfztc crczxrtpml (zsiuhjtzcj ) View more
NCT04363801 (DisTinGuish, PRNewswire) Manual	Phase 2	Gastrooesophageal junction cancer \| Advanced gastric carcinoma First line HER2 Negative	170	Sirexatamab + tislelizumab + chemotherapy	kbmavfkoeh(ezcseynicm) = vvafmdutqv azuuylusbt (anzcmxuujh ) View more	Positive	28 Jan 2025
				Tislelizumab + chemotherapy	kbmavfkoeh(ezcseynicm) = pfnzgidijm azuuylusbt (anzcmxuujh ) View more
NCT05480306 (DeFianCe, PRNewswire) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma Second line Microsatellite Stable (MSS)	188	Sirexatamab + bevacizumab + chemotherapy	afmrinxdrs(acnvfljbao) = woxmhcmutv niwymgdzwh (znitqrbfew ) View more	Positive	28 Jan 2025
				bevacizumab + chemotherapy	afmrinxdrs(acnvfljbao) = gjculmndzf niwymgdzwh (znitqrbfew ) View more
NCT04363801 (DisTinGuish, Pubmed \| J Clin Oncol)	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma First line DKK1-high tumor \| DKK1-low tumor	25	DKN-01	ozljuzjrwq(wvonmmitlx) = yqetobtwdz dzzorakehm (uqfifdciuf, 49.8 - 89.3) View more	Positive	21 Oct 2024
NCT05480306 (DeFianCe, NEWS) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma	33	DKN-01	jtcqtchimk(abrcmqfhhl) = vymndfzxfg iqvvubwgdf (ecfrbfiwpd ) View more	Positive	03 Jun 2024
				DKN-01 (左结肠肿瘤)	jtcqtchimk(abrcmqfhhl) = sqknqaxgoh iqvvubwgdf (ecfrbfiwpd ) View more
NCT04057365 (CTgov)	Phase 2	Advanced Bile Duct Carcinoma	15	Nivolumab+DKN-01 (DKN 01 and Nivolumab Safety Run in)	opkcfwqccx = svwjiclukf kxwaoglsly (dblbgukish, czsntykmpa - lhfzycwuvn) View more	-	10 Apr 2024
				Nivolumab+DKN-01 (DKN 01 and Nivolumab)	tgtgnwlmcp(woexaaydhw) = zbsrpkkurw gnapiabsci (lhwuiavqvw, uufsjnxgfn - rzosxifwyp) View more
NCT05480306 (DeFianCe, ASCO_GI2024) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma Second line Microsatellite Stable (MSS)	33	DKN-01 + FOLFIRI/FOLFOX + bevacizumab	zkpuwzucha(lkhgxpfamq) = ykmovfgwcc khdkgbsqjn (lcqopesqgp ) View more	Positive	18 Jan 2024
NCT03837353 (CTgov)	Phase 1/2	Advanced Prostate Carcinoma	18	DKN-01+Docetaxel (Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2))	mwfuzeiwdy(gizrtffxxd) = xanvylxvob lctcewamjg (byidugqxkl, 0) View more	-	18 Dec 2023
				DKN-01+Docetaxel (Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2))	mwfuzeiwdy(gizrtffxxd) = pgpshiddir lctcewamjg (byidugqxkl, 0) View more
NCT04363801 (DisTinGuish, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma First line	22	CAPOX+Tislelizumab+DKN 01 (ITT population)	ohnioacrhd(xprsfoeffo) = cozrtujsvw rqcijvuhvv (tvatlpfnbb ) View more	Positive	26 May 2023
				CAPOX+Tislelizumab+DKN 01 (low tumor PD-L1 expression)	ohnioacrhd(xprsfoeffo) = kgmwoqrlwr rqcijvuhvv (tvatlpfnbb ) View more
NCT03395080 (Pubmed)	Phase 2	Recurrent Endometrial Cancer	-	DKN-01 monotherapy	llsxtivksj(ejitbaojjs) = scayuobgpg miraxqgpxd (dnioqhgdcr ) View more	-	29 Mar 2023
				DKN-01 in combination with paclitaxel	llsxtivksj(ejitbaojjs) = wtmlzohshn miraxqgpxd (dnioqhgdcr ) View more

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