NCT07189949

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
28mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Oct 2025Dec 2028

First Submitted

Initial submission to the registry

September 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

September 17, 2025

Last Update Submit

March 5, 2026

Conditions

Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Outcome Measures

Primary Outcomes (5)

  • Incidence and severity of adverse events (AEs).

    Graded as per CTCAE v5.0.

    From the screening period to 30 days after the last dose.

  • Incidence and severity of serious adverse events (SAEs).

    Graded as per CTCAE v5.0.

    From the screening period to 30 days after the last dose.

  • 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.

Secondary Outcomes (15)

  • Maximum plasma concentration (Cmax).

    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.

  • Apparent volume of distribution (Vz/F).

    About 24 months.

  • +10 more secondary outcomes

Study Arms (1)

HRS-2329 Group

EXPERIMENTAL
Drug: HRS-2329 Tablet

Interventions

HRS-2329 TabletDRUG

Oral HRS-2329 tablet.

HRS-2329 Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

Central Study Contacts

Rongfu Mao

CONTACT

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

Jizhao Li

CONTACT

+86-021-61053363jizhao.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

September 17, 2025

First Posted

September 24, 2025

Study Start

October 16, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

CN(1)