An Open-Label, Multicenter, Phase IB/II Clinical Study of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors

September 2, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open-Label, Multicenter, Phase IB/II Clinical Study of the Safety, Tolerability, and Efficacy of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors

This is a Phase IB/II clinical trial designed to evaluate HRS-7172 in combination with antitumor drugs in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.

The study process includes a screening period (from signed informed consent to first dose), a treatment period (from first dose to last dose), and a follow-up period (safety and survival follow-up after last dose). A Safety Monitoring Committee (SMC), composed of the principal investigator and sponsor representatives, will be established during the study to review the safety and efficacy data generated. The SMC will make decisions on study-related matters, including but not limited to combination regimen dose exploration, combination regimen selection, efficacy expansion cohort selection, expansion initiation timing, and recommended dose for expansion (RDE).

This study aims to evaluate the safety, tolerability, and efficacy of HRS-7172 in combination with other antitumor therapies in participants with advanced or metastatic pancreatic cancer harboring RAS mutations or amplifications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Xianjun Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Capable of giving informed consent, have signed and dated the IRB/EC-approved informed consent form, and are willing and able to comply with scheduled visits, examination requirements, and other study procedures.
  2. Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of sex.
  3. ECOG performance status of 0 or 1.
  4. Locally advanced or metastatic pancreatic cancer confirmed by histology and cytology, with RAS mutation/amplification detected by tissue or blood genetic testing.
  5. Participants who have received at most one prior line of standard therapy.
  6. Life expectancy ≥ 12 weeks.
  7. At least one measurable lesion as defined by RECIST v1.1.
  8. Participants must provide formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimens.
  9. Adequate organ and bone marrow function.
  10. Female participants of childbearing potential must agree to use contraception and refrain from donating eggs from the time of signing the informed consent form until 6 months after the last dose of the study drug; serum human chorionic gonadotropin (HCG) test must be negative within 7 days prior to the first dose, and must not be breastfeeding. Male participants whose partners are women of childbearing potential must agree to use contraception and refrain from donating sperm from the time of signing the informed consent form until 5 months after the last dose of the study drug.

Exclusion Criteria:

  1. Participants with untreated or active central nervous system (CNS) metastases or leptomeningeal metastases (including history thereof).
  2. Concurrent other malignancies ≤ 3 years prior to the first dose, with the following exceptions: adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin carcinoma, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery (hormonal therapy for non-metastatic prostate cancer or breast cancer is permitted).
  3. Participants with uncontrollable tumor-related pain as determined by the investigator. Participants requiring analgesic therapy must have a stable analgesic regimen at study entry; symptomatic lesions eligible for palliative radiotherapy should have completed treatment before study entry.
  4. Severe cardiovascular or cerebrovascular diseases.
  5. Gastrointestinal diseases affecting drug administration/absorption, including but not limited to dysphagia, malabsorption syndrome, refractory nausea, vomiting, diarrhea, Crohn's disease, and ulcerative colitis; intestinal obstruction or related symptoms and signs within 6 months prior to the start of study treatment, unless surgically treated with complete resolution; clinically significant acute or chronic pancreatitis; other gastrointestinal conditions deemed unsuitable for enrollment by the investigator.
  6. Clinically significant bleeding events (including but not limited to hematemesis, melena, hematochezia, etc., excluding hemorrhoidal bleeding or isolated fecal occult blood positive) within 6 months prior to the start of study treatment, or a definite bleeding tendency, high bleeding risk, coagulation disorder, or thrombotic tendency.
  7. Clinically symptomatic moderate or severe ascites (i.e., requiring therapeutic paracentesis or drainage within 2 weeks prior to the start of study treatment; participants with only small-volume ascites on imaging without clinical symptoms may be enrolled); uncontrolled or moderate or greater pleural effusion or pericardial effusion.
  8. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization; active infection of CTCAE ≥ Grade 2 requiring systemic antibiotic therapy within 2 weeks prior to the first dose; excluding participants receiving prophylactic antibiotic therapy (e.g., for prevention of urinary tract infection).
  9. History of immunodeficiency, including HIV positive; active hepatitis B (positive HBsAg at screening with HBV DNA quantification ≥ 1000 copies/mL or 500 IU/mL) or hepatitis C (anti-HCV positive with HCV RNA positive).
  10. Active pulmonary tuberculosis infection within 1 year prior to enrollment as determined by history or imaging, or a history of active pulmonary tuberculosis infection more than 1 year ago without standard treatment.
  11. Adverse reactions from prior antitumor therapy that have not recovered to CTCAE ≤ Grade 1 (except alopecia, Grade 2 peripheral neurotoxicity, laboratory values meeting enrollment criteria, or other conditions determined by the investigator not to affect study drug treatment).
  12. Systemic antitumor therapy (including chemotherapy, biological therapy, targeted therapy, immunotherapy, radical radiotherapy, etc.) within 4 weeks prior to the start of study treatment.
  13. Major organ surgery (excluding needle biopsy), significant trauma within 4 weeks prior to the first dose of study drug, or planned elective surgery during the study; minor traumatic procedures (biopsy, endoscopy, and drainage) within 7 days prior to the first dose.
  14. Receipt of live attenuated vaccines within 28 days prior to the first dose of study drug, or anticipated need for live attenuated vaccines during the study treatment period.
  15. Pregnant or lactating women, or female participants planning to become pregnant during the study period or within 7 months after the last dose of study drug.
  16. History of severe allergic reactions to any component of any study drug to be received, or to other monoclonal antibodies.
  17. Participants judged by the investigator to have other factors that may affect study results or lead to premature study termination, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, severely abnormal laboratory values, family or social factors, and other circumstances that may affect participant safety or the collection of study data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A-low dose: HRS-7172 + AG + SHR-1316
Drug: HRS-7172 + AG + SHR-1316
HRS-7172 + AG + SHR-1316; low dose
Experimental: Treatment group A-high dose: HRS-7172 + AG + SHR-1316
Drug: HRS-7172 + AG + SHR-1316;
HRS-7172 + AG + SHR-1316; high dose
Drug: HRS-7172 + AG + SHR-1316;
HRS-7172 + AG + SHR-1316; low/high dose
Experimental: Treatment group A1: HRS-7172 + AG
Drug: HRS-7172 + AG;
HRS-7172 + AG; low/high dose
Experimental: Treatment group A2: HRS-7172 + AG + SHR-1316
Drug: HRS-7172 + AG + SHR-1316;
HRS-7172 + AG + SHR-1316; high dose
Drug: HRS-7172 + AG + SHR-1316;
HRS-7172 + AG + SHR-1316; low/high dose
Experimental: Treatment group B-low dose: HRS-717 + HRS-4642+SHR-1316
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; low dose
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; high dose
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; low/high dose
Experimental: Treatment group B-high dose: HRS-717 + HRS-4642+SHR-1316
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; low dose
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; high dose
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; low/high dose
Experimental: Treatment group B1: HRS-717 + HRS-4642
Drug: HRS-717 + HRS-4642;
HRS-717 + HRS-4642; low/high dose
Experimental: Treatment group B2: HRS-717 + HRS-4642+SHR-1316
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; low dose
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; high dose
Drug: HRS-717 + HRS-4642+SHR-1316;
HRS-717 + HRS-4642+SHR-1316; low/high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RDE in advanced pancreatic cancer with RAS mutation or amplification
Time Frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Incidence and severity of adverse events (AEs) (per NCI-CTCAE V6.0 criteria)
Time Frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
ORR assessed by the investigator
Time Frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) as assessed by the investigator
Time Frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Disease Control Rate (DCR) as assessed by the investigator
Time Frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Duration of Response (DoR) as assessed by the investigator
Time Frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Progression-Free Survival (PFS) as assessed by the investigator
Time Frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Overall Survival (OS)
Time Frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Anti-Drug Antibodies (ADA)
Time Frame: From pre-dose on C1D1 to 30 days after the last dose. Estimated to be 2 years
From pre-dose on C1D1 to 30 days after the last dose. Estimated to be 2 years
Incidence and severity of AEs
Time Frame: From the participant's signing of the informed consent form to the end of the safety follow-up period. Estimated to be 2 years
From the participant's signing of the informed consent form to the end of the safety follow-up period. Estimated to be 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-7172-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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