A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor
Palbociclib in combination with the autophagy inhibitor hydroxychloroquine (HCQ) , a phase
Ib/II study was conducted.
This study will adopt a 3+3 design and include three predefined dose groups of palbociclib:
100mg QD, 150mg QD, and 200mg QD. Initially, 600mg bid dose of hydroxychloroquine group will
be administered in combination. The trial will use the first cycle (28 days) as the
observation period for tolerability, observing and evaluating the occurrence of DLTs after
medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and
recommended phase 2 dose (RP2D) of the combination therapy.
This study improves the efficacy of CDK4/6 inhibitors in the treatment of solid tumors by
reversing DTP status through the use of HCQ.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University