Clinical Trial 23715

• Overview

  Study Title:

  A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)

  Summary:

  This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD6621. The study is split into different modules which will look at AZD6621 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels of AZD6621 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD6621 doses in a larger group of participants (dose expansion).

  Objective:

  Primary Objectives: Dose escalation (Part A) and dose expansion (optimization Part B) - To assess the safety and tolerability, characterize DLTs and determine MTD (Part A only), and/or RDE(s) of AZD6621 as monotherapy or in combination in participants with metastatic prostate cancer. Dose expansion (optimization Part B) -To assess the preliminary anti-tumor activity of AZD6621 as monotherapy or in combination in participants with metastatic prostate cancer. Secondary Objectives: Dose escalation (Part A) and dose expansion (optimization Part B) - To assess the preliminary anti-tumor activity of AZD6621 as monotherapy or in combination in participants with metastatic prostate cancer. -To characterize the PK of AZD6621 as monotherapy or in combination in participants with metastatic prostate cancer. - To determine the immunogenicity of AZD6621 as monotherapy or in combination in participants with metastatic prostate cancer. -To investigate tumor STEAP2 expression and its relationship to response to AZD6621 as monotherapy or in combination in participants with metastatic prostate cancer.

• Treatments

  Therapies:

  T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8

  Medications:

  AZD6621 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Capable of giving signed informed consent and complying to the study protocol.
  • Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form.
  • ≥ 18 years of age at the time of signing the informed consent form.
  • ECOG PS score of 0 or 1.
  • Minimum life expectancy of > 12 weeks.
  • Adequate hematological, renal, bone marrow, and liver function as documented in the protocol.
  • Body weight ≥ 35 kg.
  • Male, as assigned at birth, inclusive of all gender identities.
  • Contraceptive use by participants or participant partners as documented in the protocol and consistent with local regulations.
  • Additional criteria will apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Any evidence of diseases (such as severe or uncontrolled systemic diseases) which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
  • Cardiac arrhythmias (such as multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which are symptomatic or require treatment unless controlled by pacemaker; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease (≥ 2 years) before the first dose of study intervention and of low potential risk for recurrence.
  • History of, or planned organ or allogeneic stem cell transplantation.
  • Unresolved toxicity from prior anti-cancer therapy of CTCAE Grade ≥ 2 (exceptions listed in protocol).
  • History of Grade ≥ 3 CRS or Grade ≥ 2 ICANS based on ASTCT criteria with prior therapy. CRS must be resolved prior to screening.
  • Previous history of hemophagocytic lymphohistiocytosis/ macrophage activation syndrome.
  • Active or prior documented autoimmune or inflammatory disorders (examples in protocol) within the past 3 years prior to the start of treatment or requiring permanent immunosuppressive therapy.
  • Spinal cord compression unless asymptomatic and treated and stable and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent.
  • CNS pathology (examples in protocol).
  • Active or uncontrolled hepatitis B or C virus infection (exceptions listed in the protocol).
  • Known HIV infection that is not well controlled (definition for HIV infection that is well controlled is listed in protocol).
  • Radiation therapy within 4 weeks of first dose of study intervention (or local or focal radiotherapy within 2 weeks of first dose).
  • Prior anti-cancer drug exposure requirement as stated in study protocol
  • Previous anti-cancer treatment requirements as stated in study protocol
  • Systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent > Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose.
  • Receipt of the last dose of anti-cancer therapy or participation in another clinical study with last dose administered in the last 21 days or 5 half-lives, whichever is shorter.
  • Participants with a known hypersensitivity to AZD6621 or any of its excipients.
  • Involvement in the planning and/or conduct of the study.
  • Participant is unlikely to comply with study procedures, restrictions, and requirements (as judged by the Investigator).
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention or receipt of COVID-19 vaccination within 72 hours prior to the first dose of study intervention.
  • Previous enrolment in the present study.
  • Additional criteria may apply.

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