Clinical trial · Interventional
A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
NCT06046742CI-TRIAL-00087148recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic 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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M1-c6v1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- M1-c6v1 intravenous injection
- description
- M1-c6v1 will be administered through IV drip
- interventionNames
- Biological: M1-c6v1
Primary outcomes (3)
- measure
- Evaluate the safety and tolerability of escalating doses of intravenous M1-c6v1 in Patients with advanced malignant tumors
- timeFrame
- About 2 years
- description
- Monitor the incidence of adverse events (TEAEs) during the study.
- measure
- Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1.
- timeFrame
- About 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy. 2. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures. 3. Males and females at least 18 years of age, inclusive, at the Screening Visit. 4. Have at least one measurable lesion. 5. An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP. 6. An estimated survival time of ≥ 12 weeks. Exclusion Criteria: 1. Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy. 2. Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy. 3. Subject has received systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP. 4. Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
References
Publications (0)
Data not yet available
No reference posted for this study.