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

NCT07296341 | Recruiting Phase 1

• 1 other identifier: HRS-4642-206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Locally Advanced or Metastatic Pancreatic Cancer With

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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.

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

Secondary Outcomes (4)

• 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)

Study Arms (2)

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

EXPERIMENTAL

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

nab-paclitaxel in combination with gemcitabine

ACTIVE COMPARATOR

Drug: HRS-4642;nab-paclitaxel; gemcitabine

Interventions

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

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

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

HRS-4642;nab-paclitaxel; gemcitabine DRUG

nab-paclitaxel in combination with gemcitabine

nab-paclitaxel in combination with gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Accompanied by untreated or active central nervous system (CNS) tumor metastasis
• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Zengquan Gu

CONTACT

0518-82342973; zengquan.gu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-12

Locations

CN (1)