Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07296341

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Yupei Zhao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine

Drug

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

HRS-4642;nab-paclitaxel; gemcitabine

Drug

nab-paclitaxel in combination with gemcitabine

Primary outcomes

  1. 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

  1. Objective response rate (ORR)

    Time frame: up to 10 months following the date the last patient was randomized

    Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator.

  2. disease control rate (DCR)

    Time frame: up to 10 months following the date the last patient was randomized

    Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR.

  3. Duration of response (DoR)

    Time frame: up to 10 months following the date the last patient was randomized

    Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as assessed by investigator according to RECIST v1.1.

  4. Overall survival (OS)

    Time frame: From study start until target OS events have occurred (approximately 20 months after last patient enrollment)

    Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Zengquan Gu

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.