We will conduct a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, we will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden. In Part 2, we will investigate the efficacy of tebentafusp-tebn in combination with TACE in patients with bulky hepatic disease.

Start Date30 Apr 2025

Sponsor / Collaborator

Thomas Jefferson University

[+1]

NCT03796884

/ Active, not recruitingPhase 2IIT

Phase II Randomized, Placebo-Controlled Trial of Linaclotide to Demonstrate Bioactivity in Patients With Sporadic Colorectal Adenomas and With Colorectal Cancer

This phase II trial studies the how well linaclotide works in treating patients with stages 0-3 colorectal cancer. Linaclotide is a very small protein that binds to receptors on intestinal cells and makes them secrete water and salt.

Start Date30 Oct 2019

Sponsor / Collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

[+1]

NCT03712904

/ CompletedPhase 2IIT

Phase II Randomized Trial of Stereotactic Radiotherapy (SRT) Followed by Intravitreal Aflibercept Injection for Patients With Ocular Melanoma

This phase II trial studies how well stereotactic body radiation therapy and aflibercept work in treating patients with uveal melanoma. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving stereotactic body radiation therapy followed by aflibercept may work better in treating patients with uveal melanoma.

Start Date09 Aug 2019

Sponsor / Collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

[+1]

100 Clinical Results associated with Sidney Kimmel Cancer Center at Thomas Jefferson University

0 Patents (Medical) associated with Sidney Kimmel Cancer Center at Thomas Jefferson University

329

Literatures (Medical) associated with Sidney Kimmel Cancer Center at Thomas Jefferson University

25 Apr 2025·Cancer Research

Abstract CT268: Preliminary results from a first-in-human study of IK-595, an oral MEK/RAF molecular glue, in patients with RAS- or RAF-altered advanced solid tumors

Author: Tolcher, Anthony W. ; Damphousse, David ; Bashir, Babar ; Timothy, Marissa ; Kim, Katherine ; Bartolini, Wilmin ; Lakhani, Nehal J. ; Kacena, Katherine ; Henry, Jason T. ; Ecsedy, Jeffrey ; Luke, Jason J. ; Lingaraj, Trupti ; Spira, Alexander I. ; McKean, Meredith ; Germa, Caroline ; Valerin, Jennifer B. ; Vandross, Andrae L.

AbstractBackground:The clinical utility of MEK inhibitors is limited to BRAF V600X mutant cancers and NF1 mutant neurofibromas due to early emergence of resistance and low therapeutic indices. IK-595, a novel MEK-RAF molecular glue, traps MEK in an inactive complex with all RAF isoforms and durably blocks MEK and ERK phosphorylation. IK-595 overcomes the key resistance mechanisms to approved MEK inhibitors including CRAF-mediated MEK reactivation and kinase independent CRAF activity. Moreover, the PK profile of IK-595 enables robust but intermittent pathway inhibition, which drives apoptosis in MAPK-pathway dependent cancers while minimizing toxicity to healthy cells.Methods:This is a phase 1, first-in-human, open-label, multicenter study to evaluate IK-595 as monotherapy in pts with RAS- or RAF-altered advanced solid tumors for whom there are no treatment options known to confer clinical benefit. The study consists of a Dose Escalation phase using a Bayesian Optimal Interval design, followed by a Dose Expansion phase. In Dose Escalation, IK-595 was administered orally at doses ranging from 0.5-8 mg on intermittent dosing schedules (QOD, Q3D, QW, and BIW). Study objectives included evaluation of safety, PK, PD, and antitumor activity (RECIST 1.1).Results:As of Jan 06, 2025, 51 pts enrolled in the Dose Escalation phase across 8 dose regimens. Median age was 61 years (range 35-84); 88% of pts had RAS mutations and 12% had RAF mutations; median number of prior lines of therapy was 3. More than half (53%) of the pts had a primary diagnosis of CRC, followed by pancreatic cancer (23.5%), and others (23.5%). The treatment was well tolerated and the most common treatment-related adverse events were grade 1 or 2 rash, diarrhea, nausea, fatigue, vomiting, and retinopathy. IK-595 exposure increased dose proportionally and the t½ was ∼24 hrs. Robust pERK inhibition was demonstrated in a blood PD assay. Saturating inhibition occurred with doses ≥1 mg 4 hrs after dosing. The durability of inhibition increased with increased dose; 6mg resulted in a PD response of ∼90% at 24 hrs and ∼80% at 72 hrs. Blood samples were collected to evaluate ctDNA dynamics and will be presented. The overall DCR was 44% (15/34) in disease-evaluable pts. Significant tumor reduction was observed in 5 pts; 2 cPRs occurred in KRAS G12D gastric (2 prior lines tx) and KRAS G12D ovarian cancer (3 prior lines tx including MEKi); 1 uPR occurred in KRAS G12R pancreatic cancer with liver metastases (1 prior line tx) with responses ongoing; 2 prolonged SD occurred in Class III BRAF mutant urothelial cancer (7 lines prior tx) for 29 weeks and KRAS G12D CRC (2 lines prior tx) for 30 weeks and ongoing.Conclusion:IK-595 is well tolerated in pts with low-grade skin and GI toxicities as the most frequently observed adverse events. Encouraging target inhibition and early antitumor activity in RAS- and RAF-altered solid tumors was observed. Clinical trial information: NCT06270082Citation Format:Anthony W. Tolcher, Nehal J. Lakhani, Meredith McKean, Babar Bashir, Jason T. Henry, Andrae L. Vandross, Alexander I. Spira, Jennifer B. Valerin, Trupti Lingaraj, Katherine Kim, Wilmin Bartolini, Marissa Timothy, Katherine Kacena, David Damphousse, Jeffrey Ecsedy, Caroline Germa, Jason J. Luke. Preliminary results from a first-in-human study of IK-595, an oral MEK/RAF molecular glue, in patients with RAS- or RAF-altered advanced solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT268.

01 Mar 2025·Brachytherapy

Development and implementation of a 3d-HDR brachytherapy program for cervical cancer in a sub-Saharan African centre

Article

Author: Puthoff, David ; Ajose, Azeezat ; Balogun, Onyinye ; Ngwa, Wilfred ; Habeebu, Muhammad ; Joseph, Adedayo ; Ohazurike, Ephraim ; Onitilo, Adedayo ; Fagbemide, Olufunmilayo ; Alabi, Adewumi ; Salako, Omolola ; Nwachukwu, Chika ; Adeneye, Samuel ; Oladipo, Aishat ; Adegboyega, Bolanle ; Irabor, Omoruyi Credit ; Ogamba, Chibuzor F

BACKGROUNDCervical cancer is the second most common cancer among women in Nigeria where, the gap between need for, and access to, radiation therapy including brachytherapy is significant. This report documents the implementation of the first three-dimensional high-dose-rate (3D-HDR) brachytherapy service for cervical cancer in Nigeria.PURPOSEThis report details the steps taken to implement the 3D-HDR brachytherapy program, the challenges faced, and the adaptive strategies employed to overcome them. Our objective is to provide a guide for teams and centers in similar resource-restricted settings to implement 3D-HDR brachytherapy services, by leveraging our shared experience and lessons learned.METHOD AND METERIALSThe implementation process required investment in infrastructure: creating a dedicated brachytherapy suite equipped with modern technology; and human capital: conducting both virtual and hands-on training for staff; and involving international experts during the initial treatment phases. Quality assurance protocols were established to ensure the accuracy and safety of treatments. Key adaptations included extensive remote training, international experts flying in for the initiation phase, and preemptively re-ordering the radioisotope to prevent delays.RESULTSThe 3D-HDR brachytherapy program was successfully implemented, with five cases treated in the first 2 months despite challenges such as high equipment costs, expertise and proficiency needs, and source replacement delays. Continuous training and quality assurance measures ensured the program's sustainability and effectiveness.CONCLUSIONSImplementing a 3D-HDR brachytherapy program in a system with restricted resources is possible with thorough planning, flexible strategies, and adaptive measures. We document our experience to provide insights for other institutions aiming to establish similar programs. Collaboration and innovative financial strategies are essential for ensuring sustainable access to cancer treatment in the region. Strategies such as remote training and proactive resource management, are critical for overcoming implementation barriers.

20 Feb 2025·Journal of Clinical Oncology

Germline and Somatic Genomic Testing for Metastatic Prostate Cancer: ASCO Guideline

Review

Author: Rumble, R. Bryan ; Bitting, Rhonda L. ; Eggener, Scott E. ; Cheng, Heather H. ; Agarwal, Neeraj ; Lu, Kevin ; Mahal, Brandon ; Spratt, Daniel ; Giri, Veda N. ; Yu, Evan Y. ; Crispino, Tony ; Beltran, Himisha ; Trabulsi, Edouard J.

ASCO Guidelines provide recommendations with comprehensive review and analyses of the relevant literature for each recommendation, following the guideline development process as outlined in the

ASCO Guidelines Methodology Manual

. ASCO Guidelines follow theASCO Conflict of Interest Policy for Clinical Practice Guidelines . Clinical Practice Guidelines and other guidance (“Guidance”) provided by ASCO is not a comprehensive or definitive guide to treatment options. It is intended for voluntary use by clinicians and should be used in conjunction with independent professional judgment. Guidance may not be applicable to all patients, interventions, diseases or stages of diseases. Guidance is based on review and analysis of relevant literature, and is not intended as a statement of the standard of care. ASCO does not endorse third-party drugs, devices, services, or therapies and assumes no responsibility for any harm arising from or related to the use of this information. See complete disclaimer in Appendix 1 and 2 (online only) for more . PURPOSETo evaluate evidence on germline and somatic genomic testing for patients with metastatic prostate cancer and provide recommendations.METHODSA systematic review by a multidisciplinary panel with patient representation was conducted. The PubMed database was searched from January 2018 to May 2024. Articles were selected for inclusion if they reported on patients with metastatic prostate cancer who received a germline or somatic genomic test and/or made comparisons between those tests, reported detection rates, prognostic information, or treatment implications.RESULTSA total of 1,713 papers were identified in the literature search. After applying the eligibility criteria, 14 remained: eight systematic reviews and six clinical trials.RECOMMENDATIONS Patients with metastatic prostate cancer should undergo both germline and somatic DNA sequencing using panel-based assays. These tests can guide the use of poly(ADP-ribose) polymerase inhibitors, which have a survival benefit in metastatic castration-resistant prostate cancer. In addition, germline testing may have screening implications for additional cancers for patients and cascade testing implications for family members. The data supporting when to perform repeat testing and optimal tissue type to use (eg, primary tumor v metastatic biopsy versus circulating tumor DNA [ctDNA] testing) are more limited, but this panel recommends considering retesting in patients whose results were previously negative or uninformative, and to consider either a metastatic biopsy or ctDNA when a significant change in clinical status occurs. Next-generation genomic sequencing findings that are associated with prognostic only (and not predictive) value should not be used to guide treatment outside of a clinical trial. Additional information is available at www.asco.org/genitourinary-cancer-guidelines .

100 Deals associated with Sidney Kimmel Cancer Center at Thomas Jefferson University

100 Translational Medicine associated with Sidney Kimmel Cancer Center at Thomas Jefferson University

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Drug(Targets)	Indications	Global Highest Phase

L-Leucyl-L-Leucine Methyl Ester	Hematologic Neoplasms More	Pending
Ad5-hGCC-PADRE vaccine(Sidney Kimmel Cancer Center at Thomas Jefferson University)	-	Pending

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