Clinical trial · Interventional
A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer
A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer
NCT07079228CI-TRIAL-00095656recruitingPhase 3ClinicalTrials.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)
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine \[AG\]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel. | Drug | Nab-paclitaxel | ALIAS |
| Placebo for QLS31905 | Drug | — | UNRESOLVED |
| QLS31905 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QLS31905 + nab-paclitaxel + gemcitabine (AG)
- interventionNames
- Drug: QLS31905
- Drug: Nab-paclitaxel.
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Placebo + nab-paclitaxel + gemcitabine (AG)
- interventionNames
- Drug: Placebo for QLS31905
- Drug: Nab-paclitaxel.
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall Suryival(OS)
- timeFrame
- Up to 48 months
- description
- OS is defined as the time from randomization to deathdue to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects voluntarily participate in the study and sign the informed consent form; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; * Expected survival time ≥ 3 months; * Histologically or cytologically confirmed diagnosis of pancreatic cancer; * No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease; * At least one measurable lesion per RECIST v1.1; * Patients with adequate cardiac, liver, renal function, etc. Exclusion Criteria: * History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ; * Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study; * Known central nervous system metastases; * Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; * Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.