Clinical trial · Interventional
Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 for Injection in Combination With Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
NCT07151872CI-TRIAL-00094456not yet recruitingPhase 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 is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer
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 |
|---|---|---|---|
| CLDN18.2-positive Advanced Biliary Tract Cancer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine Tablets | Drug | Capecitabine | ALIAS |
| Cisplatin for Injection | Drug | Cisplatin | ALIAS |
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine | ALIAS |
| Oxaliplatin Injection | Drug | Oxaliplatin | ALIAS |
| QL2107 Injection | Drug | Pembrolizumab | ALIAS |
| QLS31905 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- QLS31905 +GP
- interventionNames
- Drug: QLS31905 for Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Cisplatin for Injection
- type
- EXPERIMENTAL
- label
- QLS31905 +GP+QL2107
- interventionNames
- Drug: QLS31905 for Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Cisplatin for Injection
- Drug: QL2107 Injection
- type
- EXPERIMENTAL
- label
- QLS31905 +XELOX
- interventionNames
- Drug: QLS31905 for Injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with unresectable locally advanced or metastatic Biliary Tract Cancer confirmed by histopathological or cytological examination; * Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD; * No prior systemic anti-tumor treatment for locally advanced or metastatic Biliary Tract Cancer. Exclusion Criteria: * Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations; * Subjects had other second primary malignancies within 5 years prior to the first dose; * Subjects with clinically significant hemorrhage within 3 months before the first dose;
References
Publications (0)
Data not yet available
No reference posted for this study.