Clinical trial · Interventional
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients
A Phase 1 Study to Investigate the Safety, Tolerability，Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS31903 Injection in Subjects With Advanced Solid Tumors
NCT05823285CI-TRIAL-00065845recruitingPhase 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)
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS31903 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLS31903
- description
- 0.01μg/kg-2.16 μg/kg QLS31903 for injection
- interventionNames
- Drug: QLS31903
Primary outcomes (3)
- measure
- Maximum tolerated dose（MTD）for Phase 1a
- timeFrame
- 21days or 14 days after the first target dose(whichever is longer）
- description
- The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached.
- measure
- Recommended phase 2 dose(RP2D) for Phase 1a
- timeFrame
- Duration of study, approximately 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 18 years or older, 40kg or heavier * Histologically or cytologically confirmed diagnosis of advanced solid tumor （For phase 1b, patients must have solid tumor with GPC3+ ) * Standard treatment failed or standard treatment intolerant, no standard treatment * Adequate hepatic, hematologic, and renal function Key Exclusion Criteria: * Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions * Other clinical trial within 4 weeks prior to the first QLS31903 administration * Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration * Prior treatment targeted on GPC3 * HBsAg/HBcAb positive and HBV-DNA\>10,000 copy/mL;HCV-Ab positive and HCV-RNA\>1,000 copy/mL * CNS metastasis (except asymptomatic brain metastases or symptomatic brain metastases after treatment stable for more than 4 weeks) and/or carcinomatous meningitis or leptomeningeal disease
References
Publications (0)
Data not yet available
No reference posted for this study.