An Open-Label, Multicenter, Phase IB/II Clinical Study of HRS-7172 in Combination With Antitumor Therapy in Participants With Solid Tumors
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Start
- 2026-10-15
- End
- 2029-12-31
- Enrollment
- 140
- Sites
- 1
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-7172 + AG + SHR-1316. HRS-7172 + AG + SHR-1316; low dose
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-7172 + AG + SHR-1316;. HRS-7172 + AG + SHR-1316; high dose
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-7172 + AG;. HRS-7172 + AG; low/high dose
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-7172 + AG + SHR-1316;. HRS-7172 + AG + SHR-1316; low/high dose
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-717 + HRS-4642+SHR-1316;. HRS-717 + HRS-4642+SHR-1316; low dose
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-717 + HRS-4642+SHR-1316;. HRS-717 + HRS-4642+SHR-1316; high dose
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-717 + HRS-4642;. HRS-717 + HRS-4642; low/high dose
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: HRS-717 + HRS-4642+SHR-1316;. HRS-717 + HRS-4642+SHR-1316; low/high dose
Arm · public domain (ClinicalTrials.gov) · T1
Treatment group A-low dose: HRS-7172 + AG + SHR-1316 (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Treatment group A-high dose: HRS-7172 + AG + SHR-1316 (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Treatment group A1: HRS-7172 + AG (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Treatment group A2: HRS-7172 + AG + SHR-1316 (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Treatment group B-low dose: HRS-717 + HRS-4642+SHR-1316 (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Treatment group B-high dose: HRS-717 + HRS-4642+SHR-1316 (experimental):
Primary outcome · public domain (ClinicalTrials.gov) · T1
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.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Anti-Drug Antibodies (ADA). Time frame: From pre-dose on C1D1 to 30 days after the last dose. Estimated to be 2 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
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 …
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 140 participants (estimated).