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

NCT 04644068

Brief 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.

Intervention / Treatment 

  • DrugAZD5305
  • DrugPaclitaxel
  • DrugCarboplatin
  • DrugT- Dxd
  • DrugDato-DXd
  • DrugCamizestrant

Inclusion Criteria:

  • Age ≥ 18 at the time of screening
  • Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
  • Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
  • Life expectancy ≥ 12 weeks
  • Progressive cancer at the time of study entry
  • Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
  • Adequate organ and marrow function as defined by the protocol.
  • For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.

For Part A:

– Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)

For Part B:

– Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).

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