NCT07441174

IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors

A Multicenter, Open-Label, Phase Ib/II Clinical Trial of IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: InxMed (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase Ib/II clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.

Detailed description

This is a multicenter, open-label, Phase Ib/II clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage. Phase Ib - Dose Exploration Stage: It is designed to evaluate the safety and preliminary efficacy of IN10018 in combination with RNK08954 for the treatment of KRASG12D mutation-positive locally advanced or metastatic solid tumors, and to determine the Recommended Phase 2 Dose (RP2D) of the combination therapy. Phase II - Efficacy Exploration and Determination Stage: It will further evaluate the anti-tumor efficacy, safety, and pharmacokinetic (PK) characteristics of IN10018 in combination with RNK08954 in KRASG12D mutation-positive locally advanced or metastatic solid tumor (Pancreatic ductal adenocarcinoma (PDAC) shall be prioritized for enrollment). Based on the preliminary efficacy and safety data, one or two advanced solid tumor indications, including but not limited to PDAC, NSCLC, and CRC will be selected for adoption of a factorial or other appropriate study design and determination of sample size. Discussions with Center for Drug Evaluation (CDE) shall be completed prior to initiating the registrational study.

Conditions

• Solid Tumor Cancer
• PDAC

Interventions

Type	Name	Description
DRUG	IN10018 in combination with RNK08954	Based on existing clinical data, the RP2D of IN10018 as monotherapy and in combination with chemotherapy, targeted therapy, and immunotherapy is 100 mg QD. For RNK08954 as monotherapy, the Maximum Tolerated Dose (MTD) was not reached during the dose escalation of the Phase I study, and effective doses with observed tumor responses were 800 mg QD, 1000 mg QD, and 1200 mg QD.

Timeline

• Start date: 2026-02-28
• Primary completion: 2031-02-28
• Completion: 2031-02-28
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

14 sites across 1 country: China

Regulatory

• FDA-regulated drug study