A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality |
More Jiangsu HengRui Medicine Co., Ltd. trials in China
Other trials for the same condition
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