Clinical Trials in China / NCT07189949
Recruiting
Phase 1
A Study of HRS-2329 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications
NCT07189949 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid Tumors Harboring RAS Mutations or Amplifications
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Incidence and severity of adverse events (AEs). — From the screening period to 30 days after the last dose.
Graded as per CTCAE v5.0. - 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. - 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | Recruiting |
More Jiangsu HengRui Medicine Co., Ltd. trials in China
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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 NCT07189949 on ClinicalTrials.gov ↗ ← All trials in China