A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies

ClinicalTrials.gov ID: NCT02740985

Public ClinicalTrials.gov record NCT02740985. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 7:10 AM EDT

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Official title

A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Ascending Doses of AZD4635 Both as Monotherapy and in Combination in Patients With Advanced Solid Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02740985
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: AstraZeneca; Industry
Enrollment: 313 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 130 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 16, 2016
Primary completion: Dec 30, 2020
Completion: Mar 30, 2023
Last update posted: May 25, 2023

2016 – 2023

United States locations

U.S. sites: 17
U.S. states: 13
U.S. cities: 17

Facility	City	State	ZIP	Site status
Research Site	Fayetteville	Arkansas	72703	—
Research Site	Fresno	California	93720	—
Research Site	Denver	Colorado	80218	—
Research Site	New Haven	Connecticut	06519	—
Research Site	Daytona Beach	Florida	32117	—
Research Site	Lecanto	Florida	34461	—
Research Site	North Port	Florida	34288	—
Research Site	Sarasota	Florida	34232	—
Research Site	Decatur	Illinois	62526	—
Research Site	Las Vegas	Nevada	89119	—
Research Site	New York	New York	10032	—
Research Site	Durham	North Carolina	27710	—
Research Site	Oklahoma City	Oklahoma	73104	—
Research Site	Philadelphia	Pennsylvania	19107	—
Research Site	Myrtle Beach	South Carolina	29572	—
Research Site	Chattanooga	Tennessee	37404	—
Research Site	Nashville	Tennessee	37203	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02740985, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 25, 2023 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02740985 live on ClinicalTrials.gov.

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