Testing HRS-4642 in patients with advanced solid tumors that have a KRAS G12D mutation

Phase I Study to Evaluate the Safety ,Tolerability, and Pharmacokinetics of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

This study is testing a new drug called HRS-4642 to see if it can safely help adults with advanced solid tumors that have a specific KRAS G12D mutation.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (ShangHai, Shanghai)
• Trial ID: NCT05533463 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of a new drug, HRS-4642, in patients diagnosed with advanced solid tumors that harbor the KRAS G12D mutation. The study aims to determine the maximum tolerated dose (MTD) and identify a biologically active dose for future phases. Participants will be monitored for adverse effects and overall response to the treatment. The trial is designed for adult patients who meet specific eligibility criteria related to their cancer diagnosis and health status.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with advanced solid tumors confirmed to have the KRAS G12D mutation.

Not a fit: Patients who have previously received KRAS G12D inhibitors or have unresolved adverse effects from prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring the KRAS G12D mutation.

How similar studies have performed: While this approach is focused on a specific mutation, similar studies targeting KRAS mutations have shown promise, indicating potential for success.

Eligibility criteria

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.
3. Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation
4. ECOG performance status of 0-1.
5. With a life expectancy of ≥3 months.
6. Have at least one measurable lesion.
7. Adequate laboratory parameters during the screening period

Exclusion Criteria:

1. Previously received KRAS G12D inhibitors
2. Priot radiotherapy within 28 days for non-thoracic radiation
3. Prior anti-tumor chemotherapy (\< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration
4. Any unresolved AEs \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or inclusion/exclusion criteria level (The investigators determined that safe and controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral neuropathy ).
5. Central nervous system (CNS) metastases
6. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
7. Known history of hypersensitivity to any components of HRS-4642.
8. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Where this trial is running

ShangHai, Shanghai

• Shanghai Pulmonary Hospital — ShangHai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Wei Shi

Conditions Advanced KRAS G12D Mutant Solid Tumors