Clinical trial · Interventional
Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors
NCT06446388CI-TRIAL-00077786not 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 study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced 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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Chemotherapy drug | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| QL1706 | Drug | — | UNRESOLVED |
| QLS31905 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- QLS31905 + oxaliplatin + capecitabine
- description
- Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
- interventionNames
- Drug: QLS31905
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- QL1706 + oxaliplatin + capecitabine
- description
- Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: QL1706
- type
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 locally advanced unresectable or metastatic solid tumors; * No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease; * Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC); * 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 a known history of psychoactive drug abuse, alcohol abuse, or substance abuse; * 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 and/or sponsor.
References
Publications (0)
Data not yet available
No reference posted for this study.