A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i

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 t

Trial Details

NCT ID
NCT05953350
Phase
PHASE1 / PHASE2
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • 600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib
  • RP2D dose of 600mg bid of hydroxychloroquine combined with palbociclib was selected for phase II clinical trial.
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Patients diagnosed with advanced solid tumors (including breast cancer, undifferentiated liposarcoma, etc.) confirmed by histology and/or cytology,…
  • At least one measurable target lesion according to RECIST 1.1.
  • Age 18 years or older, any gender.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

For full eligibility, visit ClinicalTrials.gov.

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