Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
NCT04644068 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 702
Last updated 2026-02-19
Summary
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Conditions
- Ovarian Cancer
- Breast Cancer
- Pancreatic Cancer
- Prostate Cancer
- Additional Indications Below for Module 4 and 5
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Bladder Cancer
- Gastric Cancer
- Biliary Cancer
- Cervical Cancer
- Endometrial Cancer
- Small Cell Lung Cancer Only in Module 5
Interventions
- DRUG
-
AZD5305
Oral PARP inhibitor
- DRUG
-
IV Anti-microtubule agent
- DRUG
-
IV Platinum chemotherapeutic
- DRUG
-
T- Dxd
IV Antibody-drug conjugate
- DRUG
-
Dato-DXd
IV Antibody-drug conjugate
- DRUG
-
Camizestrant
Oral SERD Molecule
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Timothy Yap · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-12
- Primary Completion
- 2027-05-28
- Completion
- 2027-05-28
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- China
- Czechia
- Hungary
- Italy
- Japan
- Poland
- Russia
- South Korea
- Spain
- Ukraine
- United Kingdom
Study Locations
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