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Recruiting NCT07189949

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

Phase I Interventional Advanced Solid Tumors Harboring RAS Mutations or Amplifications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-2329 Tablet.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors Harboring RAS Mutations or Amplifications. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study of HRS-2329 Evaluating Safety, Tolerability, and Pharmacokinetics in Subjects With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Overview

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.

Interventions

  • Drug HRS-2329 Tablet
    Oral HRS-2329 tablet.

Primary outcome measures

  • Incidence and severity of adverse events (AEs). [Time frame: From the screening period to 30 days after the last dose.]
  • Incidence and severity of serious adverse events (SAEs). [Time frame: From the screening period to 30 days after the last dose.]
  • Dose-limiting toxicity (DLT). [Time frame: From Day 1 to Day 21.]
  • Maximum tolerated dose (MTD). [Time frame: From Day 1 to Day 21.]
  • Recommended Phase II Dose (RP2D). [Time frame: 24 months.]
Secondary outcome measures (12)
  • Maximum plasma concentration (Cmax). [Time frame: About 24 months.]
  • The time to maximum concentration (Tmax). [Time frame: About 24 months.]
  • Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t). [Time frame: About 24 months.]
  • Area under concentration-time curve from time 0 to infinity (AUC 0-∞). [Time frame: About 24 months.]
  • Apparent volume of distribution (Vz/F). [Time frame: About 24 months.]
  • Elimination half-life (t1/2). [Time frame: About 24 months.]
  • Apparent clearance (CL/F). [Time frame: About 24 months.]
  • Minimum concentration at steady state (Cmin, ss). [Time frame: About 24 months.]
  • Area under the blood concentration-time curve at steady state (AUCss). [Time frame: About 24 months.]
  • Accumulation ratio (Rac). [Time frame: About 24 months.]
  • Objective response rate (ORR). [Time frame: About 24 months.]
  • Duration of response (DoR). [Time frame: About 24 months.]

Eligibility criteria

Inclusion criteria

  • 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 old;
  • 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;
  • ECOG performance status (PS) score of 0 or 1;
  • Life expectancy > 3 months;
  • At least one measurable lesion per RECIST v1.1;
  • Adequate organ function.

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07189949 · HRS-2329-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗