A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL).

Summary

This is a Phase 1, dose escalation study to assess the safety, tolerability, pharmacokinetic and pharmacodynamic effects of CDK-003. The study is performed in two parts: Part A is a randomized, double-blind, placebo-controlled, single ascending dose study of CDK-003 in healthy adult male participants, and Part B is a single arm, open-label, multiple ascending dose in patient-participants with CTCL. Dose escalation in the study will only occur after satisfactory review of all available predefined data by the Safety Review Committee. Part A is complete and this entry describes Part B only.

Timeline

Start

2021-09-06

Primary completion

2022-08-24

Completion

2022-08-24

Outcome

Outcome not reported

Stopped: “PK/PD from two patients plus the healthy volunteer data confirmed the RP2D and manageable safety profile. Proceeding to Phase II did not require additional data from this Phase I Dose-Finding study.”

Drugs

Indications