A Phase I/IIa Study of AZD8205 given alone or in Combination with Anticancer Drugs, in Participants

• Research type

  Research Study

• Full title

  A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies

• IRAS ID

  1007820

• Contact name

  Soumya Boucelham

• Contact email

  soumya.boucelham@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB,

• Eudract number

  2021-000736-66

• Research summary

  This is a trial to learn if AZD8205 is safe and works in people with advanced or metastatic solid tumors. The trial drug AZD8205 is designed to find and kill certain types of tumor cells. The researchers think that AZD8205 given alone or in combination with other anticancer
  drugs could work better than current treatments for advanced or metastatic solid tumors. This is a phase 1 and phase 2, open-label study, first-in-human study. In Part 1 of the study, participants will receive increasing doses of AZD8205 so researchers can learn the best or
  highest tolerated doses to give to participants during the second part. In Part 2 of the study, researchers will learn if these doses found to be safe and tolerated in Part 1. UK sites will only participate in Part 2 of the study. Participants who have metastatic or advanced forms of 1 of the following types of solid tumour cancers will be invited to participate in this study: biliary tract, ovarian, HER-2 negative breast or endometrial. AZD8205 is given through a needle directly into a vein (IV infusion) once every 3 weeks. Treatment is given until disease progression or if the patient withdraws from the study. During treatment, the researchers will keep track of the participants medical problems (adverse events) and monitor their health by performing physical examinations, checking vital signs, testing blood and urine samples and ECG traces. Tumours will be checked through biopsies and imaging. The possible benefit for participants in this trial include improvement of their cancer. Participants will help researchers learn more about whether AZD8205 can help people with advanced or metastatic solid tumors.

• REC name

  North East - York Research Ethics Committee

• REC reference

  23/NE/0153

• Date of REC Opinion

  31 Aug 2023

• REC opinion

  Further Information Favourable Opinion