ifebemtinib (IN10018) / InxMed, Boehringer Ingelheim - LARVOL DELTA

A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov) - P3 | N=416 | Not yet recruiting | Sponsor: Shanghai Jeyou Pharmaceutical Co., Ltd.

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

Tumor FAK supports fibrillar collagen expression in ovarian cancer ascites. (PubMed, Matrix Biol) - "In primary HGSOC ascites samples, FAK inhibitor (IN10018 or VS-4718) or FAK protein degrader (PROTAC) treatment selectively reduced COL1A1, COL3A1, and COL5A2 mRNA levels in tumor cells. Further, human OVCAR8 spheroid COL1A1, COL3A1, and COL5A2 mRNA and spheroid structure were significantly impacted by FAK inhibition and blocking anti-α1 or anti-β1 integrin antibodies. As elevated PTK2 and COL3A1 expression correlate with poor ovarian cancer patient survival, and FAK, α1, and β1 integrin inhibition reduced spheroid COL3A1 protein levels, our findings support a feed-forward linkage whereby FAK regulates fibrillar collagen acting in part via collagen binding integrins supporting HGSOC tumorsphere survival and metastatic spread."

Journal • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • Targeted Protein Degradation • COL1A1 • COL3A1 • COL5A2

Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. (PubMed, Lancet Respir Med) - P1/2, P3 | "The dual-oral chemotherapy-free regimen of ifebemtinib plus garsorasib had encouraging efficacy with a manageable safety profile as first-line treatment for KRASG12C-mutated NSCLC. A randomised phase 3 study has been initiated to further validate these findings against standard-of-care in the first-line setting (NCT07174908)."

Journal • P1/2 data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Hypertension • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Renal Disease • Respiratory Diseases • Solid Tumor • KRAS

InxMed Announces Publication in The Lancet Oncology Featuring Encouraging Antitumor Activity of Ifebemtinib in Combination with Garsorasib in Previously Treated Metastatic Colorectal Cancer (CRC) Harboring KRAS G12C Mutation (Yahoo Finance) - "The CRC cohort of this trial contains two parts: Part 1-single-arm study and Part 2-randomized study...In the single-arm study, 15 patients were enrolled with 14 patients evaluable, and the confirmed ORR was 46.7% (95% CI: 21.3–73.4) in the full population and 50.0% (95% CI: 23.0–77.0) in the evaluable population. In the randomized study, the confirmed ORR was 38.9% (95% CI: 17.3–64.3) in the ifebemtinib plus garsorasib group versus 16.7% (95% CI: 3.6–41.4) in the garsorasib monotherapy group, representing an absolute improvement of 22.2% in the combination group...In the single-arm study, the median OS was 14.3 months (95% CI: 4.7–NE). In the randomized study, the median OS was not estimable (95% CI: 10.2–NE) in ifebemtinib plus garsorasib group versus 7.5 months (95% CI: 5.3–NE) in garsorasib monotherapy group (HR 0.34, 95% CI: 0.11–1.12), suggesting a favorable OS trend in the combination group."

P1/2 data • Colorectal Cancer

IN10018 in Combination With Dalpiciclib for Progressive Meningiomas (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Capital Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Meningioma • Oncology • Solid Tumor

Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Trial completion date: Dec 2025 ➔ Aug 2029 | Trial primary completion date: Jul 2025 ➔ Dec 2027

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

InxMed Announces Publication in The Lancet Respiratory Medicine Featuring Promising Anticancer Activity of Ifebemtinib in combination with Garsorasib in First-Line non-small cell lung cancer (NSCLC) Harboring KRAS G12C Mutation (The Manila Times) - "High Response Rates: Of the 33 enrolled patients, 31 were evaluable. The cORR was 82% (27/33) across all enrolled patients and 87% (27/31) among evaluable patients. And tumor shrinkage was observed in all evaluable patients, even in the patient with best overall response of PD; Durable Responses: Among responders, the median Duration of Response (DOR) was Not Reached (NR) (95% CI: 15.2-NE), underscoring the potential of FAK inhibition to prevent or significantly delay treatment resistance; Prolonged survival benefit of PFS and overall survival (OS): The mPFS reached an extraordinary 22.3 months (95% CI: 9.6-NE), with 12-month and 18-month PFS rates standing at 67.9% and 58.2%, respectively. The median OS was 27.8 months (95% CI: 27.8-NE), which remained immature as most patients was censored before 27.8 months. The 12-month and 24-month OS rates were 75.8% and 69.7%, respectively."

P1/2 data • Non Small Cell Lung Cancer

HanchorBio Tests Broader Ambitions for HCB101 Through InxMed Partnership (PRNewswire) - "Under the MOU, the two companies will conduct preclinical and translational research evaluating HCB101 in combination with InxMed's investigational assets, including IN10018/ifebemtinib, a FAK inhibitor, and OMTX705....HanchorBio has been developing the asset with gastric cancer as an important clinical anchor....InxMed brings a complementary profile. Its lead asset, IN10018/ifebemtinib, has advanced into late-stage clinical development, including a Phase III trial in China for platinum-resistant recurrent ovarian cancer....The collaboration gives HanchorBio a way to test whether HCB101's macrophage-centered immune activation can be paired with drugs targeting the tumor's physical and biological defenses, including fibrosis, stromal barriers, and immune exclusion."

Licensing / partnership • Platinum resistant • Gastric Cancer • Ovarian Cancer

Safety and efficacy of ifebemtinib combined with garsorasib in KRAS G12C mutant colorectal cancer from a randomized part of a phase Ib/II study. (ASCO 2026) - P1/2 | "The combination of ifebe and D-1553, a dual-oral regimen, exhibits favorable safety profiles and better efficacy in treating KRAS G12C mutant CRC, with mOS exceeding 16 months. Clinical findings from this randomized study have shown robustness of improvement in overall ORR, PFS, DOR and OS benefit with this combination regimen, indicating that adding ifebe to a RASi can further improve clinical outcome to CRC patients with RAS G12C mutation. Efficacy."

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

A phase II trial of a FAK inhibitor combined with albumin-bound paclitaxel and an anti–PD-1/CTLA-4 bispecific antibody for metastatic, recurrent, or persistent gastric-type endocervical adenocarcinoma (GIFT Study). (ASCO 2026) - P2 | "This study aims to evaluate the efficacy and safety of the FAK inhibitor IN10018 in combination with immunotherapy and chemotherapy in patients with GAC...As of the data cutoff, 14 of the planned 25 patients have been enrolled. The trial is registered at ClinicalTrials.gov (NCT06654011)."

Bispecific • Metastases • P2 data • Cervical Adenocarcinoma • Cervical Cancer • Oncology • CTLA4 • PD-1

IN10018 in Combination With Dalpiciclib for Progressive Meningiomas (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Capital Medical University

New P1 trial • Brain Cancer • Meningioma • Oncology • Solid Tumor

Safety and efficacy of ifebemtinib (IN10018) combined with garsorasib (D-1553) in KRASG12C mutant solid tumors from a phase Ib/II study: 2-year follow-up from single-arm of non-small-cell lung cancer (NSCLC). (ASCO 2026) - P1/2 | "Ifebe plus D-1553 exhibited robust, durable antitumor activity and a favorable safety profile in treatment-naïve KRASG12C-mutant NSCLC patients regardless of PD-L1 expression. Notably, TP53-wild-type KRASG12C tumors typically show poor responsiveness and short durability to ICI therapies, likely due to reduced PD-L1 expression and lower tumor mutational burden. The superior outcomes in TP53 wild-type patients suggest this combination may address an unmet need in this distinct population."

Clinical • IO biomarker • P1/2 data • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • TMB • TP53

Targeting stromal FAK signaling to address chemotherapy and immunotherapy resistance in gastric-type endocervical adenocarcinoma. (ASCO 2026) - P2 | "Based on these findings, we initiated a multicenter, phase II clinical trial evaluating the FAK inhibitor IN10018 in combination with nab-paclitaxel and cadonilimab in patients with metastatic, recurrent, or persistent GAC (NCT06654011). Gastric-type endocervical adenocarcinoma is a stroma-driven malignancy in which aberrant stromal FAK signaling is a central mediator of resistance to both chemotherapy and immunotherapy. Targeting this stromal dependency provides a compelling therapeutic strategy and directly informs an ongoing phase II clinical trial addressing a critical unmet need in this aggressive disease."

Stroma • Cervical Adenocarcinoma • Cervical Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • CAFs • CD8 • ITGA1 • ITGB1 • LAMA3

IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: InxMed (Shanghai) Co., Ltd. | Trial completion date: Dec 2025 ➔ Sep 2026 | Trial primary completion date: Dec 2025 ➔ May 2026

Platinum resistant • Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Synergistic disruption of KRAS and FAK pathways: A preclinical pipeline for PDAC therapy optimization (AACR 2026) - "Preliminary data from four KRAS-mutant PDOs (G12D, G12V, G12R) revealed robust synergy between RMC-6236 and either FAK inhibitor, with up to 10-fold and 100-fold increases in efficacy for defactinib or ifebemtinib and RMC-6236, respectively. Western blot analysis confirmed suppression of RAS-MAPK signaling, downregulation of c-MYC, and increased apoptotic markers including cleaved PARP and activated Caspase-3. These findings support the potential of KRAS-FAK co-targeting strategies in PDAC and lay the groundwork for future clinical development."

IO biomarker • Preclinical • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CASP3 • KRAS • MYC

IN10028, a next-generation FAK inhibitor discovered for the treatment of solid tumors (AACR 2026) - "Compared to IN10018, a first-generation FAK inhibitor, IN10028 shows superior cancer cell cytotoxicity. Through experiments conducted in animal models, IN10028 was evaluated in both monotherapy and combination therapy settings, consistently outperforming multiple first-generation FAK inhibitors in terms of tumor growth inhibition. Additionally, pharmacokinetic and toxicity studies necessary for Investigational New Drug (IND) filing have been completed, with the IND application anticipated in December 2025."

Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Inhibition of Focal Adhesion Restricts Chemoresistance in Pancreatic Cancer by Targeting SLC7A11 Mediated Ferroptosis. (PubMed, Adv Sci (Weinh)) - "Gemcitabine-based chemotherapy regimens have shown limited antitumor effects for PDAC, and combination targets are urgently needed to restrict chemoresistance. Mechanistically, the focal adhesion kinase (FAK) inhibitor (IN10018) could restrict chemoresistance to Gem of PDAC by targeting SLC7A11-mediated ferroptosis through PI3K-Akt signaling pathway. For tumor microenvironment, IN10018 reduced the abundance of mesenchymal components and enhanced CD8+ T cell infiltration."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD8 • SLC7A11

Targeting FAK exhibits therapeutic effects on interstitial lung disease induced by trastuzumab deruxtecan (AACR 2025) - "Notably, we have now identified that FAK inhibition by the small molecule inhibitor Ifebemtinib (aka IN10018, Ifebe) can mitigate Enhertu-induced ILD. Collectively, the combination of FAK inhibition and Enhertu may offer improved therapeutic efficacy while mitigating ILD-related toxicities. These findings warrant further clinical investigation."

Oncology • Solid Tumor

Targeting FAK by Ifebemtinib synergizes with Pan RAS inhibitors in treating RAS mutant cancers (AACR 2025) - "Co-administration of a clinical-stage FAK inhibitor, Ifebemtinib (also known as Ifebe, IN10018), with RMC6236, a Pan-RAS inhibitor, exhibited synergistic cytotoxic effects in multiple RAS-mutant cancer cell lines. In summary, our study reveals that the combination of FAK inhibitor Ifebe with Pan-RAS inhibitor exhibits synergistic anti-cancer effects and further improves the outcomes of PD-1 blockade therapy. These preclinical results support the need for further clinical investigation."

IO biomarker • Oncology • KRAS • NRAS

Targeting FAK improves the tumor penetration of antibody-drug conjugates to strengthen the anti-cancer responses (AACR 2024) - "Antibody-drug conjugates (ADCs) such as HER2 ADC Enhertu and TROP2 ADC Trodelvy have been proved to be the promising therapeutic agents in portion of cancer diseases. The combination regimen comprising IN10018 and the ADCs targeting either HER2 or TROP2 outperformed each monotherapy with respect to antitumor outcomes in different animal experiments. The preclinical evidence for the dual regimen of IN10018 and ADCs warrants a further validation in clinical settings."

ADC • Oncology • CAFs • HER-2

Comprehensive study of imidazole-based hydrazones: From design, synthesis, and characterization to in vitro and in silico antiproliferative activity analysis. (PubMed, Turk J Chem) - "All synthesized compounds had higher cytotoxic activity against MCF-7 cells (IC50 < 9.262 μM) than the control drug cisplatin...All compounds showed higher binding affinity to these proteins than the standards used for comparison (erlotinib, sorafenib, copanlisib, and ifebemtinib)...The MD simulation results showed that the complex was stable during the 100 ns simulation. When all studied parameters were evaluated, compound 7c had the most potential for further drug development."

Journal • Preclinical • Breast Cancer • Lung Cancer • Oncology • Solid Tumor

IN10018 Combination Therapy in Previously-treated Solid Tumors (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: InxMed (Shanghai) Co., Ltd. | N=72 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: InxMed (Shanghai) Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor • KRAS

Focal adhesion kinase inhibition enhances response to checkpoint immunotherapy in hepatocellular carcinoma. (PubMed, J Transl Int Med) - "These models were treated with FAK inhibitor IN10018 as monotherapy or in combination with anti-PD-1 immunotherapy...FAK inhibitors can enhance the sensitivity of HCC to anti-PD-1 therapy by inhibiting angiogenesis and fibrosis and promoting CD8+ T cell infiltration. This effect exceeds the efficacy of the current first-line treatment, highlighting FAK inhibition as a novel and promising therapeutic strategy for HCC."

IO biomarker • Journal • Fibrosis • Hepatocellular Cancer • Immunology • Liver Cancer • Oncology • Solid Tumor • CD8 • KRAS • PTK2 • TP53