Clinical trial · Interventional
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
NCT07296341CI-TRIAL-00100812recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Pancreatic Cancer With | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine | Drug | — | UNRESOLVED |
| HRS-4642;nab-paclitaxel; gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
- interventionNames
- Drug: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- nab-paclitaxel in combination with gemcitabine
- interventionNames
- Drug: HRS-4642;nab-paclitaxel; gemcitabine
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.