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Clinical Trials/NCT07296341
NCT07296341
Recruiting
Phase 1

A Phase IB/II Study To Evaluate the Safety, Tolerability, and Preliminary Efficacy of HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country60 target enrollmentStarted: January 8, 2026Last updated:
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InterventionsHRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabineHRS-4642;nab-paclitaxel; gemcitabine

Overview

Phase
Phase 1
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Progression free survival (PFS)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form
  • •ECOG performance status 0 or 1
  • •Life expectancy of greater than or equal to 12 weeks.
  • •Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology
  • •Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred).
  • •At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)

Exclusion Criteria

  • •Accompanied by untreated or active central nervous system (CNS) tumor metastasis
  • •Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria
  • •Subjects known or suspected to have interstitial pneumonia
  • •According to the common adverse reaction event evaluation criteria NCI-CTCAE v5.0, patients with ≥ grade 3 serous fluid accumulation or imaging evidence of a large amount of abdominal fluid accumulation (those who require therapeutic puncture and drainage within 2 weeks before starting the study treatment, only those with imaging showing a small amount of ascites and no clinical symptoms can be enrolled)
  • •Acute or chronic pancreatitis with significant clinical significance

Arms & Interventions

HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine

Experimental

Intervention: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine (Drug)

nab-paclitaxel in combination with gemcitabine

Active Comparator

Intervention: HRS-4642;nab-paclitaxel; gemcitabine (Drug)

Outcomes

Primary Outcomes

Progression free survival (PFS)

Time Frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months

PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.

Secondary Outcomes

  • Objective response rate (ORR)(up to 10 months following the date the last patient was randomized)
  • disease control rate (DCR)(up to 10 months following the date the last patient was randomized)
  • Duration of response (DoR)(up to 10 months following the date the last patient was randomized)
  • Overall survival (OS)(From study start until target OS events have occurred (approximately 20 months after last patient enrollment))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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