Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Alaunos Therapeutics
- Enrollment
- 7
- Primary Endpoint
- toxicities
Study Overview
Brief Summary
This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.
Detailed Description
The primary objective of the trial is to determine the maximum tolerated dose (MTD) and optimal dosing schedule of indibulin in combination with capecitabine in subjects diagnosed as having advanced solid tumors.
Secondary objectives include the determination of dose-limiting toxicity (DLT), safety and tolerability, and preliminary activity of this combination. In addition, biological activity of indibulin in combination with capecitabine will be evaluated.
Single arm, open label, Phase Ib, dose-escalation study of indibulin in combination with capecitabine in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with capecitabine is considered medically acceptable.
3 subjects will be treated at each dose level. When DLT occurs in 2 or more of 6 or fewer subjects, MAD has been reached and the dose will be reduced to the previous dosing level, which will be considered the MTD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
single
Single arm designed to elicit Maximum Tolerated Dose
Intervention: indibulin (Drug)
single
Single arm designed to elicit Maximum Tolerated Dose
Intervention: capecitabine (Drug)
Outcomes
Primary Outcomes
toxicities
Time Frame: 6 months
Secondary Outcomes
- pharmacokinetics(6 months)