A Phase I/​IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies

NCT 05123482

Brief Summary

This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents

Intervention / Treatment 

  • DrugAZD8205
  • DrugAZD8205 and AZD2936 (Rilvegostomig)
  • DrugAZD8205 and AZD5305 (saruparib)
  • DrugAZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig)

Inclusion Criteria:

  • Age ≥ 18 years
  • Relapsed/metastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy.
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  • Life expectancy ≥ 12 weeks
  • Adequate bone marrow, hepatic, and renal function as defined in the protocol

Additional Inclusion Criteria For Sub-Study 1 Part A:

• Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer

Additional Inclusion Criteria For Sub-Study 1 Part B:

  • Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort:
    1. Cohort B1 (Biliary Tract Cancer)
    2. Cohort B2 (Ovarian Cancer)
    3. Cohort B3 (Breast Cancer)
    4. Cohort B4 (Endometrial Cancer)
    5. Cohort B5 (Squamous Non-Small Cell Lung Cancer)

      Additional Inclusion Criteria For Sub-Study 2 Part A:

  • Minimum body weight ≥ 30 kg.
  • Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.

Additional Inclusion Criteria For Sub-Study 3 Part A:

  • Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).
  • Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.

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