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

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NCT05797168 · readout in 716 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
602estimated
Sites
60
Countries
Australia, Canada, China +9

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-06-05actualWhen the study began enrolling
Primary completion2028-08-04estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2028-08-04estimatedThe whole study's end, after follow-up
First posted2023-04-04actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-23actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Ovarian Cancer
  • Lung Adenocarcinoma
  • Endometrial Cancer
  • Lung Squamous Cell Carcinoma

Interventions

  • Drug: Torvutatug samrotecan — also filed as Torvu-sam, AZD5335
  • Drug: Saruparib — also filed as AZD5305
  • Drug: Bevacizumab — also filed as Avastin
  • Drug: Carboplatin — also filed as Paraplatin
  • Drug: Palacaparib — also filed as AZD9574
  • Drug: Pembrolizumab

Primary outcomes

what the primary-completion date above is the date OF
Number of participants with adverse events/serious adverse events
measured From time of Informed Consent to 30 days post last dose.
The number of participants with dose limiting toxicity(DLT), as defined in the protocol
measured From the first dose of torvu-sam on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (At the end of 21 days)

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