A Multicenter, Open-label Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GH21 Combined With D-1553 in Patients With Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.

Start Date01 Jul 2024

Sponsor / Collaborator

Qinhao Pharmaceutical (Suzhou) Co., Ltd.

[+1]

CTR20240098 / RecruitingPhase 3

一项评估D-1553对比多西他赛治疗既往标准治疗失败的KRAS G12C突变阳性局部晚期或转移性非小细胞肺癌的随机、对照、双盲双模拟、多中心III期临床研究

[Translation] A randomized, controlled, double-blind, double-dummy, multicenter phase III clinical study evaluating D-1553 versus docetaxel in the treatment of KRAS G12C mutation-positive locally advanced or metastatic non-small cell lung cancer that has failed previous standard treatment

主要目的比较D1553和多西他赛治疗既往标准治疗失败KRAS G12C突变阳性局部晚期或转移型NSCLC受试者的无进展生存期（PFS）。

[Translation]

Primary objective: To compare the progression-free survival (PFS) of D1553 and docetaxel in patients with KRAS G12C mutation-positive locally advanced or metastatic NSCLC who have failed previous standard therapy.

Start Date28 Mar 2024

Sponsor / Collaborator

InventisBio, Co., Ltd.

NCT06300177 / RecruitingPhase 3

A Randomized, Controlled, Double-blind, Double-simulated, Multicenter Phase III Clinical Study Evaluating D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure.

The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint.

Start Date28 Mar 2024

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Garsorasib

100 Translational Medicine associated with Garsorasib

100 Patents (Medical) associated with Garsorasib

Literatures (Medical) associated with Garsorasib

02 Dec 2023·Expert review of anticancer therapy

Efficacy and toxicity of drugs targeting KRAS ^G12C mutation in non-small cell lung cancer: a meta-analysis

Review

Author: Zhang, Wenxue ; Zhu, Jing ; Zhou, Wei ; Xu, Ke ; Luo, Wei ; Yu, Airu

OBJECTIVE:

To systematically analyze the efficacy and toxicity of drugs targeting KRAS^G12C mutation in non-small cell lung cancer (NSCLC).

METHODS:

The candidate studies were identified in PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases up to 1 June 2023. Data on efficacy, prognosis, and adverse events (AEs) were extracted and calculated by meta-analysis.

RESULTS:

Six eligible prospective studies were included in this meta-analysis, including 563 patients with advanced or metastatic NSCLC. For patients with NSCLC, the objective response rate (ORR) of drugs targeting KRAS^G12C mutation was 37% (95%CI 31-43), median duration of response (DOR) was 8.89 months (95%CI 7.96-9.83), and median progression-free survival (PFS) was 6.40 months (95%CI 5.86-6.93). The overall incidence of AEs was 88% (95%CI 79-96) and the incidence of grade ≥3 AEs was 44% (95%CI 24-64). The most common AEs were diarrhea, nausea, fatigue, and vomiting. The most common grade ≥3 AEs were Alaninetransaminase (ALT) or Aspartatetransaminase (AST) increased and diarrhea.

CONCLUSION:

Sotorasib, Adagrasib, and Garsorasib as the drugs of choice for patients with KRAS^G12C mutation NSCLC, have definite efficacy and acceptable safety, especially for patients with advanced or metastatic disease and within posterior line therapy.

01 Jul 2023·Cancer science

D-1553: A novel KRAS^G12C inhibitor with potent and selective cellular and in vivo antitumor activity.

Article

Author: Zhu, Qingqing ; Dai, Xing ; Jiang, Yueheng ; Zhang, Yihong ; Tao, Liangshan ; Yang, Hong ; Weng, Yan ; Liu, Rongfeng ; Wang, Zhenwu ; Weng, Jifang ; Niu, Haotao ; Shi, Zhe ; Wang, Yaolin ; Mei, Hong ; Zhang, Ling ; Huh, Seok Jae

D-1553 is a small molecule inhibitor selectively targeting KRAS^G12C and currently in phase II clinical trials. Here, we report the preclinical data demonstrating antitumor activity of D-1553. Potency and specificity of D-1553 in inhibiting GDP-bound KRAS^G12C mutation were determined by thermal shift assay and KRAS^G12C -coupled nucleotide exchange assay. In vitro and in vivo antitumor activity of D-1553 alone or in combination with other therapies were evaluated in KRAS^G12C mutated cancer cells and xenograft models. D-1553 showed selective and potent activity against mutated GDP-bound KRAS^G12C protein. D-1553 selectively inhibited ERK phosphorylation in NCI-H358 cells harboring KRAS^G12C mutation. Compared to the KRAS WT and KRAS^G12D cell lines, D-1553 selectively inhibited cell viability in multiple KRAS^G12C cell lines, and the potency was slightly superior to sotorasib and adagrasib. In a panel of xenograft tumor models, D-1553, given orally, showed partial or complete tumor regression. The combination of D-1553 with chemotherapy, MEK inhibitor, or SHP2 inhibitor showed stronger potency on tumor growth inhibition or regression compared to D-1553 alone. These findings support the clinical evaluation of D-1553 as an efficacious drug candidate, both as a single agent or in combination, for patients with solid tumors harboring KRAS^G12C mutation.

25 Nov 2021·NatureQ1 · CROSS-FIELD

Diverse alterations associated with resistance to KRAS(G12C) inhibition

Q1 · CROSS-FIELD

Article

Author: Arbour, Kathryn C ; Loomis, Brian R ; Riely, Gregory ; Lipford, J Russell ; Mohn, Deanna ; Reis-Filho, Jorge S ; Bahr, Amber ; Lito, Piro ; Weigelt, Britta ; Lim, Lee P ; Zhao, Yulei ; Arora, Kanika S ; Lucas, Jessica ; Saiki, Anne Y ; Kim, Dongsung ; Ang, Agnes ; Berger, Michael ; Li, Chuanchuan ; Murciano-Goroff, Yonina R ; Li, Mark ; Mai, Trang T ; Xue, Jenny Y ; Sisk, Ann E ; Roy, Rohan S ; Achanta, Pragathi ; Li, Bob T ; de Stanchina, Elisa ; Da Cruz Paula, Arnaud F

Inactive state-selective KRAS(G12C) inhibitors^1-8 demonstrate a 30-40% response rate and result in approximately 6-month median progression-free survival in patients with lung cancer⁹. The genetic basis for resistance to these first-in-class mutant GTPase inhibitors remains under investigation. Here we evaluated matched pre-treatment and post-treatment specimens from 43 patients treated with the KRAS(G12C) inhibitor sotorasib. Multiple treatment-emergent alterations were observed across 27 patients, including alterations in KRAS, NRAS, BRAF, EGFR, FGFR2, MYC and other genes. In preclinical patient-derived xenograft and cell line models, resistance to KRAS(G12C) inhibition was associated with low allele frequency hotspot mutations in KRAS(G12V or G13D), NRAS(Q61K or G13R), MRAS(Q71R) and/or BRAF(G596R), mirroring observations in patients. Single-cell sequencing in an isogenic lineage identified secondary RAS and/or BRAF mutations in the same cells as KRAS(G12C), where they bypassed inhibition without affecting target inactivation. Genetic or pharmacological targeting of ERK signalling intermediates enhanced the antiproliferative effect of G12C inhibitor treatment in models with acquired RAS or BRAF mutations. Our study thus suggests a heterogenous pattern of resistance with multiple subclonal events emerging during G12C inhibitor treatment. A subset of patients in our cohort acquired oncogenic KRAS, NRAS or BRAF mutations, and resistance in this setting may be delayed by co-targeting of ERK signalling intermediates. These findings merit broader evaluation in prospective clinical trials.

News (Medical) associated with Garsorasib

30 May 2024

·www.prnewswire.com

InxMed Reports Positive Phase Ib/II Results for Ifebemtinib in Combination with Garsorasib in Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation

Ifebemtinib in combination with garsorasib in NSCLC showed ORR of 90.3% and DCR of 96.8% Ifebemtinib is a highly selective, orally administered, focal adhesion kinase inhibitor with significant synergies with a broad spectrum of therapeutic modalities NANJING, China, May 30, 2024 /PRNewswire/ -- InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against tumor-treatment resistance and metastasis, today announced results from the Phase Ib/II clinical trial of ifebemtinib, the company's focal adhesion kinase (FAK) inhibitor, in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation, for the first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation. These results will be featured in a poster presentation (Abstract: 8605 | Poster #469) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, IL. As of the cutoff date of May 10, 2024, a total of 33 subjects were enrolled in the study. Among the 31 evaluable patients, the antitumor responses were assessed and summarized as follows: The objective response rate (ORR) was 90.3% (95% CI: 74.3, 98.0), and the disease control rate (DCR) was 96.8% (95% CI: 83.3, 99.9). A total of 28 partial responses (PRs) and two stable diseases (SDs) were reported. Twenty-six out of 28 PRs were confirmed thus far. The data for median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) are still maturing. The overall safety profile of the combination of ifebemtinib with garsorasib is consistent with either ifebemtinib or garsorasib monotherapy. Most treatment-related adverse events (AEs) were Grade 1 or 2, and some Grade 3 AEs were reported. "The objective responses in patients exceeded our initial expectations. The combination regimen was well tolerated with known, non-overlapping, and manageable AEs from both agents," said Zhengbo Song, M.D., Associate Professor, Director of Phase 1 Unit, Zhejiang Cancer Hospital, University Chinese Academy of Sciences and Principal Study Investigator. "These data warrant further investigation to assess the potential of ifebemtinib to impact the future standard of care for KRAS G12C mutant-driven NSCLC, with or without immunotherapies in the combination regimen." "We are highly encouraged by the results of the current clinical study of ifebemtinib in NSCLC. RAS mutations account for approximately 30 percent of all cancer patients, and KRAS mutations, including the G12C mutation, wreak havoc in many people with solid tumors, including lung, pancreatic, and colorectal cancers," stated James McLeod, M.D., Chief Medical Officer of InxMed. "With recent rapid advances in KRAS G12C inhibitors comes the need for further improving clinical responses and safety/tolerability profiles of treatment regimens. We have studied FAK tumor biology and designed the combination therapy with KRAS inhibitors based on our deep understanding of FAK's roles in the tumor defense mechanism. We are pleased to see that ifebemtinib significantly amplifies the clinical responses of the combination regimen." Dr. McLeod added, "The current data set, albeit early with PFS and DOR data, is still maturing but is consistent with the results from our clinical trials in other tumor types. These initial findings demonstrate the potential of ifebemtinib to become an anchor component in combination regimens with chemotherapies, targeted therapies, or immunotherapies. We will continue further exploring the clinical utility of ifebemtinib in combination therapy and certainly welcome collaborations with global leaders in cancer therapies." About Ifebemtinib Ifebemtinib (IN10018, BI853520) is a highly selective, orally administered, small molecule inhibitor for focal adhesion kinase, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, ifebemtinib has demonstrated therapeutic synergies with chemotherapy agents, targeted therapies, and immunotherapies. InxMed is currently pursuing a registrational trial in platinum-resistant ovarian cancer in China, and multiple proof-of-concept trials are ongoing in lung, colorectal, melanoma, and pancreatic cancers, with select tumor types to progress into pivotal clinical trials. Thus far, more than 600 patients have been treated with ifebemtinib, and a favorable safety and tolerability profile was observed. Ifebemtinib was granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track designation from the U.S. Food and Drug Administration (FDA). InxMed plans to submit a New Drug Application to the NMPA in early 2025. About InxMed InxMed Co. Ltd is a clinical-stage biotech company developing innovative therapies against tumor treatment resistance and metastasis. Established in 2018, InxMed has built an efficient engine for clinical translational research driven by an in-depth understanding of disease biology. InxMed's pipeline includes several compounds targeting tumor defense mechanisms with highly differentiated therapeutic candidates. For more information, visit en.inxmed.com. SOURCE InxMed Ltd

Clinical ResultFast TrackASCOImmunotherapyPhase 1

10 Jul 2023

·www.prnewswire.com

KRAS Inhibitors Market is Evolving Rapidly at a CAGR of 36% by 2032, Assesses DelveInsight

The treatment landscape for KRAS-mutant cancers has been rapidly evolving, with several promising advancements in recent years. The KRAS inhibitors market is expected to grow significantly in the coming years, driven by the increasing incidence of cancer and the growing demand for personalized cancer treatments, ongoing research and clinical trials have identified potential treatment strategies. LAS VEGAS, July 10, 2023 /PRNewswire/ -- DelveInsight's KRAS Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging KRAS inhibitors, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the KRAS Inhibitors Market Report As per DelveInsight analysis, the KRAS inhibitors market size in the 7MM was approximately USD ~240 million in 2022. According to the assessment done by DelveInsight, the total KRAS-mutated cases in the 7MM comprised more than ~ 490,000 cases in 2022 and are projected to increase during the forecast period. Leading inhibitors companies such as Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio, and others are developing novel KRAS inhibitors that can be available in the KRAS inhibitors market in the coming years. The promising KRAS inhibitors in the pipeline include JDQ443, Divarasib, Avutometinib (VS-6766), RMC-4630, Onvansertib, IMM-1-104, Glecirasib (JAB-21822), BBP-398, MRTX1133, DCC-3116, ELI-002, D-1553, SLATE-KRAS, D3S-001, and others. Discover which therapies are expected to grab the major KRAS inhibitors market share @ KRAS Inhibitors Market Report KRAS Inhibitors Overview KRAS is a member of the RAS superfamily of small GTP-binding proteins known as RAS-like GTPases. The oncogene rat sarcoma virus (RAS) acts as a signal transducer, influencing cell proliferation, differentiation, and survival in both normal and malignant cells. The most often mutated RAS gene is KRAS, followed by NRAS and HRAS. The human KRAS gene is found on chromosome 12p12.1. It is encoded by six exons, which are positioned at locations 12 and 13 in exon 1 and, less commonly, at codons 61, 63, 117, 119, and 146. KRAS mutations can be identified through genetic sequencing of tumor tissue or through the use of a liquid biopsy. KRAS testing requests for patients are often initiated by the doctor. Typically, the examination is done on tumor tissue extracted from the patient through a previous surgery or biopsy operation. Adjuvant therapy is usually required for patients having KRAS testing who have advanced tumors. KRAS Inhibitors Epidemiology Segmentation DelveInsight estimates that there were approximately ~ 490,000 total KRAS-mutated cases in the 7MM in 2022. KRAS mutations are seen most frequently in pancreatic cancer, followed by CRC and NSCLC. The most frequent KRAS variant observed in NSCLC is G12C. In addition, the most common KRAS variation in CRC and pancreatic cancer is G12D. In the United States, KRASG12C is present in ~37% of NSCLC cases. The highest rates of KRASG12D, i.e., ~42% and 30%, were found in pancreatic cancer and CRC, respectively. The KRAS inhibitors market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Incident Cases of NSCLC, CRC, and Pancreatic Cancer Total KRAS Incident Cases in NSCLC, CRC, and Pancreatic Cancer Total KRAS Variant Cases in NSCLC, CRC, and Pancreatic Cancer KRAS Inhibitors Treatment Market Treatment choices for KRAS-mutant cancer are determined on the type of cancer, stage of the disease, and individual patient factors. The treatment landscape for KRAS-mutated cancer has been evolving. Chemotherapy drugs such as platinum-based agents (cisplatin, carboplatin), taxanes (paclitaxel, docetaxel), and others may be used to treat KRAS-mutant tumors. Chemotherapy is frequently used in conjunction with other treatments, such as targeted therapies or immunotherapies. Certain targeted therapy may be used depending on the type of cancer and the concomitant genetic changes. In colon cancer with KRAS mutations, for example, anti-EGFR antibodies (cetuximab, panitumumab) may be administered if the KRAS mutation is wild-type at codons 12 and 13. In some circumstances, alternative targeted treatments that inhibit downstream signaling pathways (such as MEK inhibitors) or angiogenesis pathways (such as anti-VEGF therapies) may be considered. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, and CTLA-4 inhibitors (ipilimumab), have transformed cancer treatment. While immunotherapy may not directly target KRAS mutations, it can improve the immune system's ability to identify and fight cancer cells. For KRAS-mutant tumors, clinical trials are looking into combining immunotherapy with other targeted medicines like chemotherapy. The FDA granted accelerated clearance to LUMAKRAS (sotorasib, Amgen) in May 2021 for the treatment of people with advanced non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation and have had at least one prior systemic therapy. The FDA granted accelerated approval for KRAZATI (adagrasib) in December 2022, a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Mirati filed a Marketing Authorization Application (MAA) in the EU in May 2022. To know more about KRAS inhibitors, visit @ KRAS Inhibitors Treatment Key KRAS Inhibitors Therapies and Companies JDQ443: Novartis Divarasib: Roche/Genentech Avutometinib (VS-6766): Verastem Oncology RMC-4630: Revolution Medicines Onvansertib: Cardiff Oncology IMM-1-104: Immuneering Corporation Glecirasib (JAB-21822): Jacobio Pharmaceuticals BBP-398: BridgeBio Pharma (Navire Pharma) MRTX1133: Mirati Therapeutics DCC-3116: Deciphera Pharmaceuticals ELI-002: Elicio Therapeutics D-1553: InventisBio SLATE-KRAS: Gritstone Bio D3S-001: D3 Bio Learn more about the FDA-approved KRAS inhibitors @ KRAS Inhibitors Drugs KRAS Inhibitors Market Dynamics The dynamics of the KRAS inhibitors market are anticipated to change in the coming years. Historically, KRAS mutations were thought to be difficult to target, and effective treatments for KRAS-mutant tumors were scarce. As a result, there is a substantial unmet need for effective therapies, resulting in high KRAS inhibitors market demand. In addition, research advances have led to the identification of possible treatment targets and techniques for KRAS-mutant malignancies. The continued development of targeted therapies, such as KRAS-G12C and Pan-KRAS inhibitors, provides a considerable KRAS inhibitors market opportunity. However, despite decades of research, there have been few viable tactics for targeting KRAS mutations, with the exception of recent breakthroughs like sotorasib and adagrasib, which have been approved to target a specific mutant version of KRAS known as KRAS (G12C). Because of its inherent properties, specifically targeting KRAS has proven to be a hard challenge. As a result, scientists have looked into alternative tactics such as targeting downstream signaling molecules, using epigenetic methods such as telomerase inhibitors and RNA interference, and adopting synthetic lethality procedures involving cyclin-dependent kinase inhibitors. Furthermore, as our understanding of KRAS biology grows, more companies and institutions are entering the sector to explore therapeutics for KRAS-mutant malignancies. The KRAS inhibitors market may grow highly competitive, with numerous companies contending for KRAS inhibitors market share. Moreover, Amgen and Mirati Therapeutics are at the forefront of the race to discover KRAS inhibitors for cancer treatment. However, their present prospects are mainly focused on G12C-mutant tumors, leaving a major gap in tackling other KRAS variations. This represents a significant unmet need in the profession, given no approved treatments are currently available for other variations. Recognizing this difficulty, multiple prominent players are currently investigating alternate KRAS variations and expanding their research to cover tumors other than NSCLC. This shift in focus has the potential to lead to the development of successful medicines that can address a broader spectrum of KRAS mutations and target numerous cancer types. Scope of the KRAS Inhibitors Market Report Therapeutic Assessment: KRAS Inhibitors current marketed and emerging therapies KRAS Inhibitors Market Dynamics: Attribute Analysis of Emerging KRAS Inhibitors Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, KRAS Inhibitors Market Access and Reimbursement Discover more about KRAS inhibitors drugs in development @ KRAS Inhibitors Clinical Trials Table of Contents Related Reports JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. TIGIT Inhibitors Competitive Landscape TIGIT Inhibitors Competitive Landscape – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TIGIT inhibitors companies, including Merck Sharp & Dohme, Bristol-Myers Squibb, BeiGene, Arcus Biosciences, iTeos Therapeutics, Mereo BioPharma, Phio Pharmaceuticals, Bio-Thera Solutions, Compugen, among others. Checkpoint Inhibitors Competitive Landscape Checkpoint Inhibitors Competitive Landscape – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key checkpoint inhibitors companies, including BeBetter Med, BIOCAD, CanBas Co., Ltd., Laekna Therapeutics, Genentech, Alphamab Oncology, Hangzhou Sumgen Biotech, Harbour BioMed, Aurigene Discovery Technologies, BeiGene, Apollomics, BCN Biosciences, Phio Pharmaceuticals, Atridia, Jiangsu HengRui Medicine, EMD Serono, Innovent Biologics, Agenus, among others. PD-1 and PD-L1 Inhibitors Competitive Landscape PD-1 and PD-L1 Inhibitors Competitive Landscape – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD-1 and PD-L1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Drug ApprovalImmunotherapy

100 Deals associated with Garsorasib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	CN	InventisBio, Co., Ltd.	28 Mar 2024
KRAS G12C mutant Non-small Cell Lung Cancer	Phase 3	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	28 Mar 2024
KRAS G12C mutation Solid Tumors	Phase 2	CN	InventisBio, Co., Ltd.	22 Dec 2021
Advanced Malignant Solid Neoplasm	Phase 2	US	InventisBio, Co., Ltd.	02 Oct 2020
Advanced Malignant Solid Neoplasm	Phase 2	AU	InventisBio, Co., Ltd.	02 Oct 2020
Advanced Malignant Solid Neoplasm	Phase 2	KR	InventisBio, Co., Ltd.	02 Oct 2020
Advanced Malignant Solid Neoplasm	Phase 2	TW	InventisBio, Co., Ltd.	02 Oct 2020
Colorectal Cancer	Phase 2	US	InventisBio, Co., Ltd.	02 Oct 2020
Colorectal Cancer	Phase 2	AU	InventisBio, Co., Ltd.	02 Oct 2020
Colorectal Cancer	Phase 2	KR	InventisBio, Co., Ltd.	02 Oct 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2024 Manual	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C	123	Garsorasib 600 mg	runrhtmmdr(amxjigbybw) = tecghudxxc uzztkdfxav (pxpusilijk, 40.5 ~ 58.8) View more	Positive	05 Apr 2024
NCT04585035 \| NCT05383898 (ESMO2023) Manual	Phase 1/2	KRAS p.G12C mutant pancreatic cancer KRAS G12C Mutation	10	D-1553	fcxlawwgsa(eeebedvjxt) = qddovkacpq wxkbsnrrtt (vecndkzjfe, 1.25-NA) View more	Positive	23 Oct 2023
NCT04585035 (ESMO2023) Manual	Phase 2	KRAS G12C mutant Colorectal Cancer KRAS G12C	29	D-1553+cetuximab	cnjujgldle(rrznhydesp) = glsjszlgdh djmakcvpgf (xnolrhbgeu ) View more	Positive	21 Oct 2023
NCT04585035 (ASCO2023) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer KRAS G12C Mutation	24	D-1553	zppslfdfrb(tvahhhdwll) = rmceyxnabd etycdogotw (weoferhnbu, 2.89 - 9.53) View more	Positive	31 May 2023
NCT05383898 (WCLC2022)	Phase 1	Metastatic Solid Tumor \| Non-Small Cell Lung Cancer	79	D-1553 600 mg QD	xoohhkddxi(rvlgexrjta) = tgfsgxfpfq aylxfqfdqt (tknjnlklzu ) View more	-	06 Aug 2022
NCT04585035 (AACR2022) Manual	Phase 1	Metastatic Solid Tumor KRAS G12C Mutation	22	D-1553	lutqrzanzp(nunjtmorpz) = skkuynjzmo qcjzollqla (flxiveffcy ) View more	Positive	15 Jun 2022
NCT04585035 (AACR2022) Manual	Phase 1	Non-Small Cell Lung Cancer KRAS G12C Mutation	28	D-1553	mldovefkha(bykshoxcsp) = rrotrqcyhn jxvitmobsb (sssdniuhfk ) View more	Positive	15 Jun 2022
NCT04585035 (AACR2021)	Phase 1/2	KRAS G12C mutation Solid Tumors	-	D-1553	zgpavhmrcx(slsxmfnjju) = urvsrtvoyp grwdwvmlel (wxsjmqczxd )	-	01 Jul 2021

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