Advanced Solid Tumors Harboring RAS Mutations or AmplificationsPhase 1NCT07189949
A Study of HRS-2329 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications
A Phase 1 study testing HRS-2329 Tablet in people with Advanced Solid Tumors Harboring RAS Mutations or Amplifications, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors Harboring RAS Mutations or Amplifications
- What is being tested?
- HRS-2329 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300181
Jihui Hao, +86-022-23340123, haojihui@tjmuch.com
Jihui Hao
About this study
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
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.
- Being tested
- HRS-2329 Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2329 TabletDrug
Oral HRS-2329 tablet.
| Study group | Role | What they receive |
|---|---|---|
| HRS-2329 Group | Experimental | Not described Receives: Drug: HRS-2329 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs).
Graded as per CTCAE v5.0.
Measured: 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.
Measured: From the screening period to 30 days after the last dose.
Dose-limiting toxicity (DLT).
Measured: From Day 1 to Day 21.
Maximum tolerated dose (MTD).
Measured: From Day 1 to Day 21.
Recommended Phase II Dose (RP2D).
Measured: 24 months.
Secondary outcomes (15)
Maximum plasma concentration (Cmax).
Measured: About 24 months.
The time to maximum concentration (Tmax).
Measured: About 24 months.
Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t).
Measured: About 24 months.
Area under concentration-time curve from time 0 to infinity (AUC 0-∞).
Measured: About 24 months.
Apparent volume of distribution (Vz/F).
Measured: About 24 months.
Elimination half-life (t1/2).
Measured: About 24 months.
Apparent clearance (CL/F).
Measured: About 24 months.
Minimum concentration at steady state (Cmin, ss).
Measured: About 24 months.
Area under the blood concentration-time curve at steady state (AUCss).
Measured: About 24 months.
Accumulation ratio (Rac).
Measured: About 24 months.
Objective response rate (ORR).
Measured: About 24 months.
Duration of response (DoR).
Measured: About 24 months.
Disease control rate (DCR).
Measured: About 24 months.
Progression-free survival (PFS).
Measured: About 24 months.
Overall survival (OS).
Measured: About 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start16 Oct 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors Harboring RAS Mutations or AmplificationsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189949
- Sponsor's protocol ID
- HRS-2329-101
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07189949
- Acronym / sponsor ID
- HRS-2329-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-2329 Group | Experimental | Drug: HRS-2329 Tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-2329 TabletOral HRS-2329 tablet. | Drug | HRS-2329 Group |
Primary outcome
Incidence and severity of adverse events (AEs).
Time frame: 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).
Time frame: From the screening period to 30 days after the last dose.
Graded as per CTCAE v5.0.
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.
15 secondary outcomes
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.
Disease control rate (DCR).
Time frame: About 24 months.
Progression-free survival (PFS).
Time frame: About 24 months.
Overall survival (OS).
Time frame: About 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-2329 Tablet in people with Advanced Solid Tumors Harboring RAS Mutations or Amplifications, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rongfu Mao (+86 021-61053363, rongfu.mao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs). (time frame: From the screening period to 30 days after the last dose.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.