CLINICAL TRIALS PROFILE FOR AZD4635
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Clinical Trials for AZD4635
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02740985 ↗ | A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies | Active, not recruiting | AstraZeneca | Phase 1 | 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. |
| NCT03381274 ↗ | Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study | Active, not recruiting | MedImmune LLC | Phase 1/Phase 2 | The objective of this study is to investigate the safety, tolerability and antitumor activity of novel combination therapies administered in subjects with advanced EGFRm NSCLC |
| NCT03710434 ↗ | AZD4635 Relative Bioavailability Study | Completed | Quotient Sciences | Phase 1 | To investigate the pharmacokinetics and relative bioavailability of AZD4635 solid oral formulation and compare with the nano-suspension reference formulation with the option to assess food effect, pH effect and absolute bioavailability |
| NCT03710434 ↗ | AZD4635 Relative Bioavailability Study | Completed | AstraZeneca | Phase 1 | To investigate the pharmacokinetics and relative bioavailability of AZD4635 solid oral formulation and compare with the nano-suspension reference formulation with the option to assess food effect, pH effect and absolute bioavailability |
| NCT03980821 ↗ | A Phase I Study of AZD4635 in Japanese Patients With Advanced Solid Malignancies | Completed | AstraZeneca | Phase 1 | This is a Phase I, open-label study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of AZD4635 in Japanese patients with advanced solid malignancies. This study consists of 2 cohorts, Cohort1 and Cohort2. At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in Cohort1 and 6 evaluable patients will be enrolled in Cohort2. |
| NCT04089553 ↗ | An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer | Active, not recruiting | AstraZeneca | Phase 2 | This is an open-label Phase II modular study in patients with prostate cancer which will assess safety, efficacy, and tolerability of AZD4635 in combination with other therapeutic agents in different treatment arms (referred to as modules). Combinations to be studied include: 1) Module 1: AZD4635 plus durvalumab; 2) Module 2: AZD4635 plus oleclumab; 3) Module 3: AZD4635 plus durvalumab plus oleclumab. The protocol may be amended to include other combinations. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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