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OncoMatch/Clinical Trials/NCT05123482

A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies

Official title: A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

Is NCT05123482 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments for breast cancer.

Phase 1/2RecruitingAstraZenecaNCT05123482Data as of Oct 2026Location: International · 15 countries

Treatment: AZD8205 · AZD8205 and AZD2936 (Rilvegostomig) · AZD8205 and AZD5305 (saruparib) · AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig) · AZD8205 in combination with AZD9574 · AZD8205 in combination with AZD9574 plus rilvegostomig (AZD2936) — 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

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Extracted eligibility criteria

Treatments studied

Other

AZD8205AZD8205 and AZD2936 (Rilvegostomig)AZD8205 and AZD5305 (saruparib)AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig)AZD8205 in combination with AZD9574AZD8205 in combination with AZD9574 plus rilvegostomig (AZD2936)

Cancer type

Breast Carcinoma

Ovarian Cancer

Endometrial Cancer

Non-Small Cell Lung Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: systemic therapy — metastatic or relapsed disease

Participants must have progressed following at least one but no more than 3 prior lines of treatment for metastatic or relapsed disease and have no satisfactory alternative treatment option as judged by the Investigator.

Cannot have received: TOP1 inhibitor (irinotecan, topotecan, trastuzumab deruxtecan)

Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)

Cannot have received: PARP inhibitor (AZD9574)

Patients have received prior therapy with AZD9574 or more than 1 prior line of any other PARPi-based regimen

Cannot have received: PARP inhibitor

Exception: more than 1 prior line of any other PARPi-based regimen

Patients have received prior therapy with AZD9574 or more than 1 prior line of any other PARPi-based regimen

Cannot have received: rilvegostomig (rilvegostomig)

Previous treatment with rilvegostomig for the cohort treated with rilvegostomig

Lab requirements

Blood counts

Adequate bone marrow function as defined in the protocol

Kidney function

Adequate renal function as defined in the protocol

Liver function

Adequate hepatic function as defined in the protocol

Adequate bone marrow, hepatic, and renal function as defined in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Duarte, California
  • Research Site · Irvine, California
  • Research Site · Santa Monica, California
  • Research Site · Santa Rosa, California
  • Research Site · Shreveport, Louisiana

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05123482 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior TOP1 inhibitor, PARP inhibitor, PARP inhibitor disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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