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NCT07296341RecruitingPhase 1/2

HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors

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

Source: ClinicalTrials.gov · Last updated 14 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
9 Dec 2025
Start date
8 Jan 2026
Primary completion date
31 Oct 2027
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
NCT number
NCT07296341

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 60
  • From 8 Jan 2026 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria
  • 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)

Other

  • Accompanied by untreated or active central nervous system (CNS) tumor metastasis
  • Subjects known or suspected to have interstitial pneumonia
  • Acute or chronic pancreatitis with significant clinical significance

Who the study is looking for

  • 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)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.