A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2021-10-31
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be
conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose
Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2
dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK
(pharmacokinetics).
The Dose Escalation Phase and is no longer enrolling. The Dose Expansion Phase currently has
two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and
the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).
Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic
Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection
Phase: Phase 1/2