CYCAD-1

• Research type

  Research Study

• Full title

  A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants with Selected Advanced or Metastatic Solid Tumors (CYCAD-1)

• IRAS ID

  1008594

• Contact name

  Assim Khan

• Contact email

  assim.khan@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2023-507305-33

• Research summary

  Researchers are looking for a better way to treat advanced or metastatic solid tumours.
  One type of drug currently used to treat advanced or metastatic solid tumours is a CDK4/6 inhibitor. The trial drug, AZD8421, is a similar type of drug called a CDK2 inhibitor. Researchers think that taking AZD8421 alone or combined with other cancer drugs could help to treat women with advanced or metastatic solid tumours who have received certain cancer treatments previously, including CDK4/6 inhibitors and chemotherapy, that stopped working.
  This trial has parts called “modules”, and more modules may be added to the trial later. Each module has groups of participants called “cohorts”. Within each cohort, there are smaller groups of participants who take different doses of AZD8421. There is currently one Module:

  In Module 1 up to 96 participants will take different doses of AZD8421 alone.

  Researchers will try to find the best dose to use in future trials.

  All participants will be females who are 18 years of age or older and who have either advanced or metastatic breast cancer that came back after treatment with CDK4/6 inhibitors or metastatic ovarian cancer that came back after treatment with chemotherapy.

  AZD8421 is taken as a tablet daily until disease progression or if the patient withdraws from the study.

  During treatment, researchers will monitor the participants’ medical problems (adverse events) and health by performing physical examinations, checking vital signs, testing blood and urine samples and ECG traces. Tumours will be checked
  through biopsies and imaging.

  We do not know if taking part in this study will improve your condition.
  Participants will help researchers learn more about AZD8421.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  23/LO/0889

• Date of REC Opinion

  11 Dec 2023

• REC opinion

  Further Information Favourable Opinion