Clinical trial · Interventional
6MW3511 in Patients With Advanced Solid Tumor
A Phase I/II, Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of 6MW3511 in Patients With Advanced Solid Tumor
NCT05524194CI-TRIAL-00060631unknownPhase 1 / Phase 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 is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: 6MW3511
- description
- Subjects will receive 6MW3511 by intravenous administration.
- interventionNames
- Drug: Intravenous Infusion
Primary outcomes (2)
- measure
- Number of participants with a Dose Limiting Toxicity (DLT)
- timeFrame
- Up to Week 3
- description
- DLTs will be assessed during the first 3 weeks of treatment for dose-escalation phase.
- measure
- Number of participants with adverse events (AEs)
- timeFrame
- Up to 4 weeks after last treatment
- description
- Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. In dose-escalation cohorts, histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.In the dose-expansion cohorts , histologically or cytologically confirmed selected advanced solid tumors (to be determined). 2. Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive). 3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. Exclusion Criteria: 1. History of other malignant tumors within 3 years, except for the tumors that had been cured. 2. Symptomatic or active central nervous system metastasis. 3. Patients with active autoimmune disease. 4. History of allogeneic hematopoietic stem cell transplantation or organ transplantation. 5. Patients previously treated with PD-（L）1/ TGF-β antibody or combined PD-（L）1 with TGF-β antibody. 6. Pregnant or breast feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.