Phase I testing of HRS-6093 for advanced solid tumors with KRAS G12D mutation

A Phase I Study of HRS-6093 Evaluating Safety, Tolerability, and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

This Phase I study will test whether the experimental drug HRS-6093 is safe, tolerable, and how it behaves in the body for adults with advanced solid tumors that carry the KRAS G12D mutation.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07134998 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center Phase I study enrolls adults with advanced solid tumors confirmed to harbor KRAS G12D mutations who have failed or are intolerant of standard therapies. It begins with a dose-escalation phase to identify tolerated dose levels, then moves to dose-expansion and efficacy-expansion cohorts to further characterize safety, tolerability, and pharmacokinetics. Participants must have ECOG performance status 0–1, measurable disease by RECIST v1.1, and provide tumor tissue for central confirmation. Treatment and follow-up are conducted at participating centers in China.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed advanced solid tumors harboring KRAS G12D, ECOG 0–1, measurable disease, adequate organ function, life expectancy >3 months, and who have exhausted or cannot tolerate standard treatments are the intended candidates.

Not a fit: Patients with active CNS metastases, unresolved Grade >1 toxicity from prior therapy, poor performance status, or inability to attend the China study sites are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, HRS-6093 could provide a new targeted option that shrinks or stabilizes tumors driven by KRAS G12D.

How similar studies have performed: Direct clinical proof targeting KRAS G12D is limited; there is promising preclinical data and early-phase work but little established clinical benefit so far.

Eligibility criteria

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;

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Rongfu Mao

Conditions Advanced KRAS G12D Mutant Solid Tumors