Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT05797168
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Torvutatug samrotecan — DRUG
    IV Antibody-drug conjugate
  • Saruparib — DRUG
    Oral PARP inhibitor
  • Bevacizumab — DRUG
    IV Monoclonal antibody
  • Carboplatin — DRUG
    IV Alkylating agent
  • Palacaparib — DRUG
    Oral PARP inhibitor
  • Pembrolizumab — DRUG
    IV Biologic

Study Details

This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors

Key Dates

Start date
Jun 5, 2023
Status verified
Jun 2026
Primary completion
Jan 6, 2028
Completion
Jan 6, 2028

Study Design

Enrollment
506 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: Torvu-sam Monotherapy
    Torvu-sam Monotherapy
  • Experimental: Module 2: Torvu-sam + Saruparib
    Torvu-sam + Saruparib
  • Experimental: Module 3: Torvu-sam + Bevacizumab
    Torvu-sam + Bevacizumab
  • Experimental: Module 4: Torvu-sam + Carboplatin +/- Bevacizumab
    Torvu-sam + Carboplatin +/- Bevacizumab
  • Experimental: Module 5: Torvu-sam + Palacaparib +/- Bevacizumab
    Torvu-sam + Palacaparib +/- Bevacizumab
  • Experimental: Module 6: Torvu-sam + Pembrolizumab +/- Palacaparib
    Torvu-sam + Pembrolizumab +/- Palacaparib

Primary Outcome Measure

Number of participants with adverse events/serious adverse events [ Time Frame: From time of Informed Consent to 30 days post last dose. ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteIrvineCalifornia92618-
Research SiteLa JollaCalifornia92093-
Research SiteAuroraColorado80045-
Research SiteLouisvilleKentucky40202-
Research SiteBostonMassachusetts02114-
Research SiteDetroitMichigan48201-
Research SiteColumbusOhio43201-
Research SitePortlandOregon97239-
Research SiteProvidenceRhode Island02903-
Research SiteProvidenceRhode Island02905-
Research SiteHoustonTexas77030-
Research SiteFairfaxVirginia22031-

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