Clinical trial · Interventional
A Study of QLS31905 in Patients With Advanced Solid Tumors
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of QLS31905 in Patients With Claudin18.2-positive Advanced Solid Tumors
NCT05278832CI-TRIAL-00057099unknownPhase 1ClinicalTrials.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 a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS31905 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLS31905
- description
- QLS31905 injection
- interventionNames
- Drug: QLS31905
Primary outcomes (2)
- measure
- Dose limiting toxicities(DLTs)
- timeFrame
- 2 years
- description
- Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905
- measure
- Maximum tolerated Dose(MTD)
- timeFrame
- 2 years
- description
- To evaluate the safety and tolerability of QLS31905
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent. 2. ≥18 years. 3. Female or male. 4. ECOG performance status score 0 or 1. 5. Histologically or cytologically confirmed diagnosis of advanced solid tumors. 6. Adequate haematological, hepatic and renal function. Exclusion Criteria: 1. Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment. 2. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease. 3. Patients with a history of monoclonal antibody allergic reaction. 4. Known human immunodeficiency virus infection or known symptomatic hepatitis.
References
Publications (0)
Data not yet available
No reference posted for this study.