A Study of HRS-2329 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Tumors Harboring RAS Mutations or Amplifications
• Interventions: Drug: HRS-2329 Tablet

• Registration Number: NCT07189949
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

This is an open-label, multi-center phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of HRS-2329 in participants with advanced solid tumors harboring RAS mutations or amplifications.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-10-01
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 old;
3. Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor RAS mutations or amplifications and have failed 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;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-2329 Group	HRS-2329 Tablet	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs).	From the screening period to 30 days after the last dose.	Graded as per CTCAE v5.0.
Dose-limiting toxicity (DLT).	From Day 1 to Day 21.
Maximum tolerated dose (MTD).	From Day 1 to Day 21.
Recommended Phase II Dose (RP2D).	24 months.
Incidence and severity of serious adverse events (SAEs).	From the screening period to 30 days after the last dose.	Graded as per CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax).	About 24 months.
Apparent volume of distribution (Vz/F).	About 24 months.
The time to maximum concentration (Tmax).	About 24 months.
Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t).	About 24 months.
Area under concentration-time curve from time 0 to infinity (AUC 0-∞).	About 24 months.
Elimination half-life (t1/2).	About 24 months.
Apparent clearance (CL/F).	About 24 months.
Minimum concentration at steady state (Cmin, ss).	About 24 months.
Area under the blood concentration-time curve at steady state (AUCss).	About 24 months.
Accumulation ratio (Rac).	About 24 months.
Objective response rate (ORR).	About 24 months.
Duration of response (DoR).	About 24 months.
Disease control rate (DCR).	About 24 months.
Progression-free survival (PFS).	About 24 months.
Overall survival (OS).	About 24 months.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin Municipality, China