Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 28 February 2026
- Expected end
- 28 February 2031
- Enrollment
- 92 participants
- Sites
- 14
- Primary outcomes
- Phase Ib:Recommended phase II dose (RP2D) of IN10018 in combination with RNK08954; Phase II: To evaluate the rate of Objective Response Rate (ORR) of IN10018 in combination with RNK08954 in subjects with KRASG12D mutation-positive locally advanced or metastatic solid tumors.
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 12 November 2026
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.