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Recruiting NCT07296341

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

Phase I / Phase II Interventional Locally Advanced or Metastatic Pancreatic Cancer With

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine, HRS-4642;nab-paclitaxel; gemcitabine.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Pancreatic Cancer With. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Objective response rate (ORR) [Time frame: up to 10 months following the date the last patient was randomized]
  • disease control rate (DCR) [Time frame: up to 10 months following the date the last patient was randomized]
  • Duration of response (DoR) [Time frame: up to 10 months following the date the last patient was randomized]
  • Overall survival (OS) [Time frame: From study start until target OS events have occurred (approximately 20 months after last patient enrollment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT07296341 · HRS-4642-206

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗