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BlueStar

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)

Open
Prior lines
1, 2
Histology
Endometrioid, Mucinous Serous Clear-cell Carcinocarcoma Other (bv. mixed/rare)
Phase
I/II
IMP
AZD8205
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

All patients in this trial will receive AZD8205, a antibody drug conjugate.
No randomization is performed

Treatment duration

AZD8205 are administered until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility

Main inclusion criteria:

  • 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
  • Histologically or cytologically confirmed metastatic or locally advanced/recurrent endometrial cancer

Main exclusion criteria:

  • Treatment with any of the following:
    • Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
    • Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment
    • Any other anticancer treatment within the following time periods prior to the first dose of study intervention:
      • Cytotoxic treatment: 21 days
      • Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
      • Biological products including immuno-oncology agents: 28 days
  • Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT05123482). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be

More information on this trial (NCT05123482)