Evaluating D-1553 and IN10018 for KRAS G12C Mutant Solid Tumors

A Phase 1b/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

This study is testing a new combination treatment for patients with advanced solid tumors that have a KRAS G12C mutation to see if it is safe and effective.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: InxMed (Shanghai) Co., Ltd. (Industry-sponsored)
• Locations: 10 sites (Hangzhou, Zhejiang and 9 other locations)
• Trial ID: NCT06166836 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety and efficacy of D-1553 in combination with IN10018 for patients with locally advanced or metastatic solid tumors that have a KRAS G12C mutation. The study consists of two phases: a Phase Ib dose escalation to determine the recommended phase 2 dose (RP2D) and a Phase II dose expansion that includes three cohorts targeting advanced colorectal cancer, non-small cell lung cancer, and other solid tumors. Participants will be monitored for safety, tolerability, pharmacokinetics, and antitumor activity. The trial aims to provide insights into the effectiveness of this combination therapy in a specific patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed KRAS G12C mutations in their solid tumors who have progressed on standard therapies.

Not a fit: Patients without KRAS G12C mutations or those with early-stage tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with KRAS G12C mutant solid tumors.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Men or women aged ≥ 18 years at the time of signing the informed consent form.
2. Subjects with pathologically confirmed locally advanced or metastatic solid tumors.
3. Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA.
4. Tumor types in different phases and cohorts: 1) Phase 1b: subjects with locally advanced or metastatic solid tumors who have progressed on or failed in standard therapy, and no standard treatment is available. 2) Phase II Cohort A: subjects with locally advanced or metastatic CRC. 3) Phase II Cohort B: subjects with locally advanced or metastatic NSCLC. 4) Phase 2 Cohort C: subjects with other locally advanced or metastatic solid tumors.
5. Has measurable lesions at baseline according to RECIST 1.1 criteria.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose.

Exclusion Criteria:

1. Prior KRAS G12C inhibitors treatment.
2. Have known symptoms of spinal cord compression, instable or symptomatic central nervous system (CNS) metastases, and/or carcinomatous meningitis.
3. Have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose.
4. Have had interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose.
5. Has a history of severe cardiovascular disease such as acute myocardial infarction, severe/unstable angina, QTc prolongation, or poorly controlled hypertension.
6. Haven't recovered from toxicity due to prior antitumor therapy
7. Pregnant or lactating women.
8. Malignant neoplasms other than study disease within 5 years prior to enrollment.

Where this trial is running

Hangzhou, Zhejiang and 9 other locations

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• First Affiliated Hospital of Bengbu Medical College — Bengbu, China (Recruiting)
• Hunan Cancer Hospital — Changsha, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• First Affiliated Hospital of Gannan Medical University — Ganzhou, China (Recruiting)
• General Hospital Of Eastern Theater Command — Nanjing, China (Recruiting)
• Renmin Hospital of Wuhan University — Wuhan, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)
• The first Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Principal investigator: Zhengbo Song — Study Principal Investigator
• Study coordinator: Shu Fang

Conditions Solid Tumor