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Active, not recruiting Phase 1/2

A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

NCT06385678 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2024-07-05
Last updated
2025-09-19

Condition(s) studied

Advanced KRAS G12D Mutant Solid Tumors

Investigational drug(s) / intervention(s)

HRS-4642 →Adebrelimab →SHR-9839 →Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for InjectionCetuximab Solution for Infusion →

HRS-4642: administrated per dose level in which the patients are assigned

Adebrelimab: administrated per dose level in which the patients are assigned

SHR-9839: administrated per dose level in which the patients are assigned

Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection: administered as prescribed by the investigator.

Cetuximab Solution for Infusion: administrated per dose level in which the patients are assigned

Study summary

The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. With a life expectancy of ≥12 weeks. 5. With unresectable locally advanced or metastatic solid tumors harbouring with KRAS G12D mutation confirmed by central laboratory testing. 6. Need to provided tumor tissue samples for genetic testing. 7. Have at least one measurable lesion according to RECIST1.1, and the dose-escalation phase allows no measurable lesion. 8. Adequate laboratory parameters during the screening period. Exclusion Criteria: 1. Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis. 2. Systemic antitumor therapy was received 4 weeks before the start of the study. 3. Palliative radiotherapy was completed within 14 days before the first dose. 4. Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria. 5. Subjects with known or suspected interstitial pneumonia. 6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion. 7. Have poorly controlled or severe cardiovascular disease. 8. Subjects with active hepatitis B or active hepatitis C. 9. A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation. 10. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention. 11. Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.

Primary outcome measure(s)

  • Phase IB: Safety endpoints: adverse events (AEs). — 24 months
    Assess safety and tolerability by way of adverse events (CTCAE v5.0).
  • Phase IB: Maximum tolerated dose (MTD) — From Day 1 to Day 21
    Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of treatment.
  • Phase IB:Recommended phase 2 dose (RP2D) — 24 months
    RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.
  • Phase II: Overall response rate (ORR). — 24 months.
    Evaluated by RECIST v1.1.

Trial sites (1)

FacilityCityRegionStatus
Shanghai East Hospital Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06385678 on ClinicalTrials.gov ↗ ← All trials in China