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

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 Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic Pancreatic Cancer With
• Intervention / Treatment: Drug: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine; Drug: HRS-4642;nab-paclitaxel; gemcitabine

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zengquan Gu; Phone Number: 0518-82342973; Email: zengquan.gu@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Principal Investigator: Yupei Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form
2. ECOG performance status 0 or 1
3. Life expectancy of greater than or equal to 12 weeks.
4. Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology
5. 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).
6. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)

Exclusion Criteria:

1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis
2. Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria
3. Subjects known or suspected to have interstitial pneumonia
4. 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)
5. Acute or chronic pancreatitis with significant clinical significance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine	Drug: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine; HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
Active Comparator: nab-paclitaxel in combination with gemcitabine	Drug: HRS-4642;nab-paclitaxel; gemcitabine; nab-paclitaxel in combination with gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator.	up to 10 months following the date the last patient was randomized
disease control rate (DCR)	Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR.	up to 10 months following the date the last patient was randomized
Duration of response (DoR)	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.	up to 10 months following the date the last patient was randomized
Overall survival (OS)	Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.	From study start until target OS events have occurred (approximately 20 months after last patient enrollment)

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: HRS-4642-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No