Clinical trial · Interventional
A Study of Bispecific Antibody QLS31901 in Patients With Advanced or Metastatic Malignancies
A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of QLS31901 for Injection in Patients With Advanced Malignant Tumors
NCT04954456CI-TRIAL-00053961unknownPhase 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 Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of QLS31901 in advanced or metastatic malignancies
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 Malignant Tumor | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS31901 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLS31901
- description
- Part 1 (Dose escalation): QLS31901will be administered in sequential cohorts each receiving 1 of 6 doses of QLS31901 on day 1 of every 21-day cycle (3 weeks) via IV infusion. Dose escalation will continue until an MTD is reached. Part 2 (Dose Expansion): The PK parameters of QLS31901 will be tested at 2-3 doses determined during the dose-escalation phase in subjects with advanced malignant tumor cohorts.
- interventionNames
- Drug: QLS31901
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- 21days
- description
- Safety and tolerability,as defined by the rate of treatment-related events as assessed by NCI CTCAE v5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18 to 75 years, male or female. 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1. 3. Life expectancy ≥ 12 weeks. 4. At least one measurable lesion by imaging according to RECIST v1.1 evaluation criteria 5. Patients who failed standard treatment or were absent of standard treatment and have a pathologically confirmed advanced malignant tumor. 6. Sufficient organ function before the first dose of the investigational product Exclusion Criteria: 1. Prior anti-cancer immunotherapy(Those who have received PD1 / PDL1 can be included in this study). 2. Known allergy to the investigational product or any excipient or severe anaphylaxis to other monoclonal antibodies. 3. Received any of the following treatments or drugs prior to the first dose of the study: 4. Symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis before signing of the informed consent form. 5. Patients with uncontrollable severe exudation (thoracic cavity, pericardium, abdominal cavity); 6. Presence of active autoimmune disease or has a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[patients whose condition can be controlled by thyroid hormone replacement therapy can be enrolled\]; Subjects suffer from skin diseases that does not require systemic treatment, such as vitiligo, psoriasis, alopecia, type I diabetes, or childhood asthma that has completely alleviated and does not require any adult intervention can be enrolled. Asthmatic patients requiring bronchodilators for medical intervention cannot be enrolled);
References
Publications (0)
Data not yet available
No reference posted for this study.