A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label, multicenter study of continuous oral dosing of AZD4635
administered to patients with advanced solid malignancies. Dosing will be escalated until a
maximum-tolerated dose (MTD) is determined in patients. The MTD will be defined by
dose-limiting toxicity. The study design allows an escalation of dose with intensive safety
monitoring to ensure the safety of the patients. Expansion cohorts will further assess safety
and preliminary anti-tumor activity in a variety of advanced solid tumor malignancies. Other
dosing schedules and/or combinations may be evaluated based on the emerging PK and safety
data.
The primary objectives of this study are to:
- Investigate the safety and tolerability of AZD4635 monotherapy when given orally (PO) to
patients with advanced solid malignancies.
- Investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4635 monotherapy
capsule formulation when given to patients with advanced solid malignancies.
- Investigate the safety and tolerability of AZD4635 PO when given in combination with
durvalumab, durvalumab plus oleclumab, or docetaxel to patients with advanced solid
malignancies and to investigate the safety and tolerability of AZD4635 in combination
with abiraterone acetate or enzalutamide in patients with mCRPC.
- Define the maximum-tolerated dose (MTD) of AZD4635 in combination with durvalumab.
- Define the recommended Phase 2 dose (RP2D) of AZD4635 in combination with abiraterone
acetate or enzalutamide.
- Determine the safety, tolerability, and immune effects of AZD4635 when administered in
combination with durvalumab to patients with non-small cell lung cancer (NSCLC) who have
previously received immunotherapy (Phase 1b portion).
- Investigate the safety and tolerability of AZD4635 capsule formulation in combination
with durvalumab and oleclumab when given to patients with mCRPC or advanced solid tumor
malignancy.
- Define the RP2D of AZD4635 capsule formulation in combination with durvalumab and
oleclumab when given to patients with mCRPC or advanced solid tumor malignancy.
- Investigate the safety and tolerability of AZD4635 capsule formulation in combination
with docetaxel when given to patients with mCRPC or advanced solid tumor malignancy.
- Define the RP2D of AZD4635 capsule formulation in combination with docetaxel when given
to patients with mCRPC or advanced solid tumor malignancy.