Clinical trial · Interventional
A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm
Phase I/II Clinical Trial of 6MW3211 Injection to Evaluate Safety, Tolerability, PK/PD, Immunogenicity and Preliminary Efficacy in Subjects With Advanced Malignant Neoplasm.(Only Phase I Has Been Submitted to US FDA)
- 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 single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion. Only Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced 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 Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 6MW3211
- description
- * Dosage form: injection * Specification: 240 mg / 8 ml/Vial
- interventionNames
- Drug: Intravenous Infusion
Primary outcomes (6)
- measure
- AEs
- timeFrame
- Up to 28 days post last dose
- description
- All the adverse events
- measure
- ORR
- timeFrame
- 1 Year
- description
- Objective Response Rate
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Men or women, age ≥18. * 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion. * 3.ECOG PS is 0 or 1. * 4.Survival expectation of at least 3 months. * 5.Adequate organs and hematopoietic functions * 6.Voluntarily signing of informed consent Exclusion Criteria: * 1.Subjects with brain metastases of clinically active central nervous system (CNS). * 2.Subjects that require to take anticoagulants and/or aspirin. * 3.Blood transfusion within 2 weeks prior to the first administration of study treatment. * 4.Inadequately controlled body cavity effusions. * 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases . * 6.Have uncontrolled systemic diseases. * 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment. * 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies. * 9.Pregnant or lactating women.
References
Publications (0)
Data not yet available