Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cancer
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Dose escalation from 0.5mg up to 3mg, the minimum increase in dose will be 0.5mg but larger increases in dose are allowed depending in the observed exposure within a cohortMasking: None (Open Label)Masking Description: Open label designPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will consist of an ascending monotherapy dose, the doses are pre-defined. The decision to escalate will be made upon the assessment of safety and tolerability data in the first cycle of treatment. Module 1 will commence with a 3+3 dose escalation design up to a recommended Phase 2 monother...
The study will consist of an ascending monotherapy dose, the doses are pre-defined. The decision to escalate will be made upon the assessment of safety and tolerability data in the first cycle of treatment. Module 1 will commence with a 3+3 dose escalation design up to a recommended Phase 2 monotherapy dose. Patients being monitored for dose limiting toxicities at each dose level. Characterisation of the PK profile, MTD and/or recommended Phase 2 dose will be defined on the emerging data Module 2: RXC004 and Nivolumab - Follows a similar 3+3 dose escalation design using RXC004 plus Nivolumab. The MTD and/or Phase 2 dose will be defined based on the PK profile, emerging safety and the appearance of any dose limiting toxicities
Tracking Information
- NCT #
- NCT03447470
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Natalie Cook The Christie NHS Foundation Trust
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