HRS-4642 with chemotherapy and immunotherapy for advanced pancreatic cancer

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 tries adding HRS-4642 to standard chemotherapy and/or an immune therapy to see if it helps people with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07296341 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, multicenter Phase II trial testing the safety, tolerability, and preliminary efficacy of HRS-4642 given in combination with other antitumor therapies in patients with advanced pancreatic cancer. Participants receive HRS-4642 combined with gemcitabine plus nab-paclitaxel or combined with the anti‑PD‑L1 agent adebrelimab in randomized treatment arms. Eligible patients are adults 18–75 years old with ECOG 0–1, measurable disease per RECIST 1.1, and available tumor tissue. The trial's primary focus is on safety and tolerability, with secondary endpoints including tumor response and early efficacy signals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with histologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, ECOG 0–1, measurable disease, and available tumor tissue for testing.

Not a fit: Patients with untreated or active brain metastases, poor performance status (ECOG >1), inability to provide required tumor tissue, or who cannot tolerate chemotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding HRS-4642 could improve tumor control or extend survival compared with standard therapy alone for some patients with advanced pancreatic cancer.

How similar studies have performed: Combining targeted agents with chemotherapy and immune checkpoint inhibitors has shown mixed results across cancers and to date has produced limited success in pancreatic cancer specifically.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Zengquan Gu

Conditions: Locally Advanced or Metastatic Pancreatic Cancer With