A Clinical Study of T3011 in Patients With Advanced Cutaneous or Subcutaneous Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Cancer
- Lung Cancer
- Melanoma
- Neoplasm Metastasis
- Neoplasm of Skin
- Soft Tissue Tumor and/or Sarcoma
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a phase 1, open-label, first-in-human study of T3011 monotherapy. The study will be conducted in 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion. The objectives of this study are to evaluate the safety and tolerability of escalating doses of T3011, and to determine the Maximum Tole...
This is a phase 1, open-label, first-in-human study of T3011 monotherapy. The study will be conducted in 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion. The objectives of this study are to evaluate the safety and tolerability of escalating doses of T3011, and to determine the Maximum Tolerated Dose (MTD) or the recommended dose(s) of T3011 by Safety Review Committee (SRC) to be further examined during Part 2. In both parts, the safety, tolerability, pharmacokinetics (PK), viral shedding, immunogenicity, and clinical activity of T3011 will be evaluated. Pharmacodynamics (PD) markers related to T3011 exposure will be characterized. Part 1 will include up to 4 dose levels (from 1E+6 PFU/mL (plaque-forming unit/milliliter) to 1E+8 PFU/mL) of 3-6 patients at each dose, enrolling a maximum of 24 patients. Approximately 30 patients will be enrolled into Part 2 Dose Expansion.
Tracking Information
- NCT #
- NCT04370587
- Collaborators
- PPD
- Investigators
- Not Provided
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