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Recruiting Phase 1

Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

NCT07134998 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-09-16
Last updated
2025-12-05

Condition(s) studied

Advanced KRAS G12D Mutant Solid Tumors

Investigational drug(s) / intervention(s)

HRS-6093

HRS-6093: HRS-6093

Study summary

This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up; 2. Aged between 18-75 years, with no gender requirement; 3. Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment, are intolerant to standard treatment, or have not received standard treatment. 4. ECOG performance status (PS) score of 0 or 1; 5. Life expectancy \> 3 months; 6. At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided. 7. Adequate organ function Exclusion Criteria: 1. Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/exclusion criteria; 2. Presence of central nervous system (CNS) metastases; 3. Participants with gastrointestinal diseases that affect drug administration/absorption 4. Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period; 5. Presence of serious pulmonary diseases 6. Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated; 7. Active or persistent gastrointestinal bleeding within 6 months prior to screening; 8. History of allogeneic bone marrow or solid organ transplantation; 9. History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening; 10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention; 11. Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA); 12. Known history of hypersensitivity to any component of the drug product to be used in the study;

Primary outcome measure(s)

  • Incidence and severity of adverse events/serious adverse events (graded as per CTCAE v5.0). — Screening Period to 30 Days After the Last Dose
  • DLT, — from day1 to day 23; 23 Days
  • MTD, — from day1 to day 23; 23 Days
  • RP2D , — 24 months

Trial sites (2)

FacilityCityRegionStatus
Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
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 NCT07134998 on ClinicalTrials.gov ↗ ← All trials in China