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

NCT07134998 | Recruiting Phase 1

• 1 other identifier: HRS-6093-101
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced KRAS G12D Mutant Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (15)

• Number of Participants With Abnormal Laboratory Values

  Screening Period to 30 Days After the Last Dose; 24 months

• Number of subjects with clinically significant changes in ECOG, vital signs and physical examination.

  Screening Period to 30 Days After the Last Dose; 24 months

• Number of subjects with changes on ECG.

  Screening Period to 30 Days After the Last Dose; 24 months

• maximum plasma concentration (Cmax),

  Screening Period to Day of the end of treatment/withdrawal. 24 months

• time to maximum concentration (Tmax),

  Screening Period to Day of the end of treatment/withdrawal. 24 months

Study Arms (1)

HRS-6093

EXPERIMENTAL

Drug: HRS-6093

Interventions

HRS-6093 DRUG

HRS-6093

HRS-6093

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
• Aged between 18-75 years, with no gender requirement;
• 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.
• ECOG performance status (PS) score of 0 or 1;
• Life expectancy \> 3 months;
• At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided.
• Adequate organ function

You may not qualify if:

• Presence of central nervous system (CNS) metastases;
• Participants with gastrointestinal diseases that affect drug administration/absorption
• 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;
• Presence of serious pulmonary diseases
• Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
• Active or persistent gastrointestinal bleeding within 6 months prior to screening;
• History of allogeneic bone marrow or solid organ transplantation;
• History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
• Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);
• Known history of hypersensitivity to any component of the drug product to be used in the study;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Rongfu Mao

CONTACT

+86 021-61053363; rongfu.mao@hengrui.com

Jizhao Li

CONTACT

+86 021-61053363; jizhao.li.jl565@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-08

Locations

CN (2)