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RecruitingNCT07189949Updated Mar 6, 2026

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

A Phase 1 interventional study of HRS-2329 Tablet in Advanced Solid Tumors Harboring RAS Mutations or Amplifications, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Advanced Solid Tumors Harboring RAS Mutations or Amplifications
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    HRS-2329 Group

    Drug: HRS-2329 Tablet

Interventions

  • DrugHRS-2329 Tablet

    Oral HRS-2329 tablet.

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AEs).

    Graded as per CTCAE v5.0.

    Time frame: From the screening period to 30 days after the last dose.

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

    Graded as per CTCAE v5.0.

    Time frame: From the screening period to 30 days after the last dose.

  3. Dose-limiting toxicity (DLT).

    Time frame: From Day 1 to Day 21.

  4. Maximum tolerated dose (MTD).

    Time frame: From Day 1 to Day 21.

  5. Recommended Phase II Dose (RP2D).

    Time frame: 24 months.

Secondary outcomes

  1. Maximum plasma concentration (Cmax).

    Time frame: About 24 months.

  2. The time to maximum concentration (Tmax).

    Time frame: About 24 months.

  3. Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t).

    Time frame: About 24 months.

  4. Area under concentration-time curve from time 0 to infinity (AUC 0-∞).

    Time frame: About 24 months.

  5. Apparent volume of distribution (Vz/F).

    Time frame: About 24 months.

  6. Elimination half-life (t1/2).

    Time frame: About 24 months.

  7. Apparent clearance (CL/F).

    Time frame: About 24 months.

  8. Minimum concentration at steady state (Cmin, ss).

    Time frame: About 24 months.

  9. Area under the blood concentration-time curve at steady state (AUCss).

    Time frame: About 24 months.

  10. Accumulation ratio (Rac).

    Time frame: About 24 months.

  11. Objective response rate (ORR).

    Time frame: About 24 months.

  12. Duration of response (DoR).

    Time frame: About 24 months.

  13. Disease control rate (DCR).

    Time frame: About 24 months.

  14. Progression-free survival (PFS).

    Time frame: About 24 months.

  15. Overall survival (OS).

    Time frame: About 24 months.

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin Municipality 300181, China
    • Jihui Hao · Contact · haojihui@tjmuch.com · +86-022-23340123
    • Jihui Hao · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07189949
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Oct 16, 2025
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Mar 6, 2026

Study contacts

Rongfu Mao
Contact
rongfu.mao@hengrui.com
+86 021-61053363
Jizhao Li
Contact
jizhao.li.jl565@hengrui.com
+86-021-61053363

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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