Clinical trial · Interventional
Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors
NCT05884801CI-TRIAL-00068427unknownPhase 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 study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS1103 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLS1103 Dose Escalation and Expansion
- interventionNames
- Drug: QLS1103
Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 21 Days (first cycle)
- measure
- Recommended dose for phase II (RP2D)
- timeFrame
- Up to 24 approximately months
- measure
- Adverse events(AEs) / Serious adverse events(SAEs)
- timeFrame
- Up to 24 approximately months
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; * 2\. Aged ≥18 years old; * 3\. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor; * 4\. Failure of adequate standard treatment, or no effective standard treatment; * 5\. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; * 6\. Life expectancy ≥12 weeks; Exclusion Criteria: * 1\. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose; * 2\. Subjects received experimental medication or therapy within 4 weeks prior to the first dose; * 3\. Subjects received major surgery within 4 weeks prior to the first dose; * 4\. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>1 severity that is related to prior therapy; * 5\. Cardiovascular and cerebrovascular diseases with clinical significance; * 6\. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.
References
Publications (0)
Data not yet available
No reference posted for this study.