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Clinical trialNCT02740985CompletedPhase 1Interventional

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

SponsorAstraZenecaEnrollment313Advanced Solid MalignanciesColorectal Carcinoma (CRC)Metastatic Castrate-Resistant Prostate Carcinoma (mCRPC)Non-Small Cell Lung Cancer (NSCLC)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Research Site

    Fayetteville, Arkansas, United States

  • Research Site

    Fresno, California, United States

  • Research Site

    Denver, Colorado, United States

  • Research Site

    New Haven, Connecticut, United States

  • Research Site

    Daytona Beach, Florida, United States

  • Research Site

    Lecanto, Florida, United States

  • Research Site

    North Port, Florida, United States

  • Research Site

    Sarasota, Florida, United States

  • Research Site

    Decatur, Illinois, United States

  • Research Site

    Las Vegas, Nevada, United States

  • Research Site

    New York, New York, United States

  • Research Site

    Durham, North Carolina, United States

  • Research Site

    Oklahoma City, Oklahoma, United States

  • Research Site

    Philadelphia, Pennsylvania, United States

  • Research Site

    Myrtle Beach, South Carolina, United States

  • Research Site

    Chattanooga, Tennessee, United States

  • Research Site

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
17 Jun 2016
Primary completion
31 Dec 2020
Completion
31 Mar 2023
Last update posted
26 May 2023
Registered enrollment
313
Registry id
NCT02740985

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.