Anfangning (garsorasib) / InventisBio, Sino Biopharm - LARVOL DELTA

a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (clinicaltrials.gov) - P1/2 | N=140 | Active, not recruiting | Sponsor: InxMed (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Galaxy-L-01: A multicenter, prospective study of garsorasib combined with anlotinib as first-line therapy for KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (ELCC 2026) - P4 | "A total of 82 eligible patients will be randomized 1:1 to either the experimental combination of garsorasib plus anlotinib (dose from single-arm phase) or standard pemetrexed-platinum chemotherapy plus PD-(L)1 inhibitor. Randomized phase primary endpoint is PFS, with secondary endpoints including DOR, DCR, TTR, OS and safety. The study is actively recruiting and has 3 patients enrolled as of 10-Jan-2026."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study) (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Garsorasib, a KRAS G12C inhibitor, with or without cetuximab, an EGFR antibody, in colorectal cancer cohorts of a phase II trial in advanced solid tumors with KRAS G12C mutation. (PubMed, Signal Transduct Target Ther) - P1/2 | "Grade ≥3 treatment-related adverse events occurred in 5 (19.2%) and 6 (14.3%) patients in monotherapy and combination cohort, respectively. Garsorasib with or without cetuximab showed a promising efficacy and manageable safety profiles in heavily pretreated patients with KRAS G12C-mutated CRC, providing a potential new treatment approach for such population."

Journal • P2 data • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Safety and efficacy of D-1553 in combination with cetuximab in KRAS G12C mutated colorectal cancer (CRC): A phase II study (ESMO 2023) - P1/2 | "Conclusions Combination of D-1553 and cetuximab showed an acceptable safety profile and achieved a higher response rate than D-1553 monotherapy and a promising PFS in heavily pretreated pts with KRAS G12C mutated CRC. More data will be presented at the meeting."

Clinical • Combination therapy • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: InxMed (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Safety and Efficacy of D-1553 in Patients with KRAS G12C Mutated Non-Small Cell Lung Cancer: A Phase 1 Trial (IASLC-WCLC 2022) - P1/2 | "D-1553 was well tolerated, with promising antitumor activity in heavily pretreated KRAS G12C mutant-NSCLC patients. The study is ongoing, and more results will be presented at the meeting."

Clinical • P1 data • Anemia • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

D-1553 (garsorasib), a Potent and Selective Inhibitor of KRAS in Patients with Non-Small Cell Lung Cancer: Phase I Study Results. (PubMed, J Thorac Oncol) - "D-1553 represents a promising therapeutic option for patients with KRAS G12C-mutated NSCLC with a well-tolerated safety profile and encouraging anti-tumor activity."

Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Garsorasib in KRAS G12C-Mutated Non-Small-Cell Lung Cancer: Updated Results from a Phase 2 Study (IASLC-WCLC 2024) - P1/2 | "Conclusions : Garsorasib has shown a high tumor response rate and long duration of response in a pretreated population of patients with KRAS G12C-mutated NSCLC. After prolonged follow up, the updated PFS and OS suggest a long-term clinical benefit, which will be further evaluated in a randomized, double-blind, controlled trial."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: InxMed (Shanghai) Co., Ltd. | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd.

New P2 trial • Solid Tumor • KRAS

Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC (clinicaltrials.gov) - P2 | N=69 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Efficacy and safety of garsorasib in patients with KRAS G12C-mutated advanced pancreatic cancer. (PubMed, Br J Cancer) - P1/2 | "Garsorasib demonstrated encouraging antitumor activity and a tolerable safety profile in patients with KRAS G12C-mutated advanced pancreatic cancer."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study. (PubMed, Eur J Cancer) - P1/2 | "This pooled analysis confirmed the robust efficacy and manageable safety of garsorasib in KRAS G12C-mutated NSCLC."

Journal • P1/2 data • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Garsorasib in Patients with KRAS G12C-Mutated Non-Small-Cell Lung Cancer: A Pooled Analysis of Phase 1/2 Study (Eur J Cancer) - "This pooled dataset included 189 patients (N=66 in phase 1 and N=123 in phase 2). The median pooled follow-up time was 13.0 months (IQR: 6.7-17.5). The objective response rate was 48.1% (95%CI: 40.8-55.5), and disease control rate was 87.8% (95%CI: 82.3-92.1). The median duration of response was 12.45 months (95% CI: 8.31, 14.49), the median progression-free survival was 9.07 months (95%CI: 7.39-9.76), and the median overall survival was 14.19 months (95%CI: 13.08-17.54)."

P1/2 data • Non Small Cell Lung Cancer

Case Report: Two cases of long-term survival in advanced pancreatic cancer patients following treatment with KRAS G12C inhibitors. (PubMed, Front Oncol) - "In this report, we present two patients with advanced PDAC with KRAS G12C mutations who achieved remarkable disease control and prolonged survival following treatment with the KRAS G12C inhibitor D1553 (garsorasib)...Case 2, a 75-year-old woman initially treated with Folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) and stereotactic body radiotherapy (SBRT), demonstrated sustained disease stability for over three years on KRAS G12C inhibitor therapy...These cases underscore the potential of KRAS-directed therapies in PDAC and illustrate the importance of molecular profiling in identifying eligible patients. The findings support further investigation into the durability of KRAS G12C inhibition, resistance mechanisms, and combination treatment strategies to optimize patient outcomes."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Galaxy-L-01: A Multicenter, Prospective Clinical Study Evaluating the Garsorasib Plus Anlotinib as First-Line Therapy for KRAS G12C-Mutant Advanced Non-Squamous NSCLC (ChiCTR) - P4 | N=104 | Not yet recruiting | Sponsor: Shanghai Chest Hospital; Shanghai Chest Hospital

New P4 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Phase II study of Garsorasib for the adjuvant treatment of KRAS G12C-mutated NSCLC (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • PD-L1

Advances in Diagnosis and Targeted Therapy of KRASG12C Mutant Non-small Cell Lung Cancer (PubMed, Zhongguo Fei Ai Za Zhi) - "In targeted therapies, KRASG12C targeted drugs, including Sotorasib, Adagrasib, Fulzerasib, Garsorasib, and Glecirasib, have demonstrated certain therapeutic efficacies in clinical trials and have obtained marketing approval. To tackle drug resistance and enhance patient's prognoses, combination therapeutic strategies that integrate targeted agents with chemotherapy, immune checkpoint inhibitors, Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitors, and epidermal growth factor receptor (EGFR) monoclonal antibodies have emerged. This paper systematically reviews the advancements in the diagnosis and targeted therapy of NSCLC with KRASG12C mutation, aiming to offer a reference for the selection of clinical treatment regimens and subsequent research.."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS

A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: InxMed (Shanghai) Co., Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Literature review of advances and challenges in KRAS G12C mutant non-small cell lung cancer. (PubMed, Transl Lung Cancer Res) - "The KRAS G12C mutation was once considered "undruggable" until the breakthrough approval of two targeted inhibitors: AMG510 (sotorasib) and MRTX849 (adagrasib). In China, IBI351 and D-1553 have also been approved for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation...Notably, recent findings indicate that combining dual immune checkpoint inhibitors (ICIs; durvalumab and tremelimumab) with chemotherapy (CT) in patients with advanced NSCLC, including those with KRAS mutations, can result in durable survival benefits...Moreover, the POSEIDON trial has highlighted the potential of dual ICI therapy combined with CT to achieve sustained clinical benefits. Despite these advances, the heterogeneity of tumor responses underscores the need for further investigation into intrinsic resistance mechanisms and the strategic optimization of combination therapies to enhance treatment outcomes."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

The objective response rate doubled over that of garsorasib in the treatment of colorectal cancer and won the STTT [Google translation] (Sino Biopharm Press Release) - P1/2 | N=180 | NCT04585035 | Sponsor: InventisBio Co., Ltd | "Recently, the research results of garsorasib...were published in the internationally renowned journal Signal Transduction and Targeted Therapy....Since the first patient was enrolled in November 2021, as of February 29, 2024, a total of 26 patients with locally advanced or metastatic CRC were enrolled in the study to receive garsorasib monotherapy, and 42 patients with locally advanced or metastatic CRC were treated with garsorasib combined with cetuximab. The confirmed ORR and DCR were 45.2% (95% CI, 29.8–61.3) and 92.9% (95% CI, 80.5–98.5), respectively. The median progression-free survival (PFS) was 7.5 months (95% CI, 5.5–8.1). At the time of data cutoff, the median OS had not yet been reached (95% CI, 11.3–NE). Most of the treatment-related adverse events (TRAEs) in the study were grade 1-2."

P2 data • Colorectal Cancer

Efficacy and safety of KRAS p.G12C inhibitors in advanced NSCLC: A systematic review and meta-analysis. (ASCO 2025) - "The KRAS p.G12C inhibitors evaluated were sotorasib, adagrasib, divarasib, and garsorasib. This meta-analysis underscores the favorable safety and efficacy profiles of KRAS p.G12C inhibitors after first-line progression in advanced NSCLC, despite the frequent adverse events, which were considered manageable. Further randomized controlled trials are expected to confirm these results and refine their role in subgroup populations, including STK1 and KEAP1 co-mutations, that confer even poor prognosis."

Metastases • Retrospective data • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AURKB • CDK7 • KEAP1 • KRAS

Safety and efficacy of ifebemtinib (IN10018) combined with garsorasib (D-1553) in KRAS G12C mutant solid tumors from a phase Ib/II study: Results from single-arm of non-small-cell lung cancer (NSCLC) and randomized part of colorectal cancer (CRC). (ASCO 2025) - P1/2 | "Combination of ifebe and D-1553, as a dual-oral regimen, is safe and highly efficacious against KRAS G12C mutant NSCLC with ORR over 90% and durable efficacy. Preliminary results from the randomized part of CRC demonstrated ORR doubling with the combo, validating the add-on benefits of ifebe. Our data suggest that ifebe could be an ideal partner of RASi."

Clinical • P1/2 data • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

An overview of PROTACs targeting KRAS and SOS1 as antitumor agents. (PubMed, Bioorg Med Chem Lett) - "Currently, four KRASG12C-specific inhibitors, namely sotorasib, adagrasib, fulzerasib and garsorasib, have garnered regulatory approval. PROTAC-mediated KRAS and SOS1 degradation has been emerged as a promising strategy to overcome these issues, and achieved rapid progress in the recent years. This article provides an overview of the chemical structures, design strategies, structure-activity relationship (SAR) studies as well as in vitro and in vivo activities of the PROTACs degrading KRAS and SOS1, and sheds light on future challenges and opportunities to accelerate the development of new chemotherapies for KRAS-driven cancers."

Journal • Review • Oncology • Targeted Protein Degradation • KRAS