Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AstraZeneca
Study ID
NCT04644068
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD5305 — DRUG
    Oral PARP inhibitor
  • Paclitaxel — DRUG
    IV Anti-microtubule agent
  • Carboplatin — DRUG
    IV Platinum chemotherapeutic
  • T- Dxd — DRUG
    IV Antibody-drug conjugate
  • Dato-DXd — DRUG
    IV Antibody-drug conjugate
  • Camizestrant — DRUG
    Oral SERD Molecule

Study Details

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.

Key Dates

Start date
Nov 12, 2020
Status verified
Feb 2026
Primary completion
May 28, 2027
Completion
May 28, 2027

Study Design

Enrollment
702 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: AZD5305 Monotherapy
    AZD5305 Monotherapy
  • Experimental: Module 2: AZD5305 + Paclitaxel
    AZD5305 + Paclitaxel
  • Experimental: Module 3: AZD5305 + Carboplatin with or without Paclitaxel
    AZD5305 + Carboplatin with or without Paclitaxel
  • Experimental: Module 4: AZD5305 + Trastuzumab Deruxtecan
    AZD5305 + T- DXd
  • Experimental: Module 5 AZD5305 + Datopotamab Deruxtecan
    AZD5305 + Dato-DXd
  • Experimental: Module 6 AZD5305 + Camizestrant
    AZD5305 + Camizestrant

Primary Outcome Measure

The number of subjects with adverse events/serious adverse events [ Time Frame: From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10021-
Research SiteOklahoma CityOklahoma73104-
Research SiteHoustonTexas77030-

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By research site
Research Site· Boston, MAResearch Site· New York, NYResearch Site· Oklahoma City, OKResearch Site· Houston, TX

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