RecruitingPhase 1 / Phase 2

A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests AZD6621, an experimental drug for prostate cancer that has spread and keeps growing despite treatment to lower testosterone. It is for adults assigned male at birth, of any gender identity. Researchers will test different doses and ways to give the drug to learn about its safety, side effects, how well it works, and how it moves through the body over time.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old, assigned male at birth, and weigh at least 35 kg (about 77 pounds).
  • Have prostate cancer confirmed by a tissue test that has spread and keeps growing despite surgery or medicine to lower testosterone.
  • Have low testosterone and a PSA level of at least 1 ng/mL. PSA is a blood marker linked to prostate cancer. Keep taking testosterone-lowering medicine if you have not had surgery to remove the testicles.
  • Have signs that the cancer has grown in the past 6 months, shown by rising PSA levels or scans.
  • Provide a new or stored tumor tissue sample. Some study groups require another biopsy, which removes a small tissue sample.
  • Meet the study group's rules for past cancer treatments and sample collection.
  • Be fully active or able to do light work. Have blood counts and kidney, bone marrow, and liver function that meet study rules, and be expected to live more than 12 weeks.
  • Sign the required consent forms, including the listed genetic research form, follow study rules, and meet birth control requirements.

Who can't join

  • Have a serious or uncontrolled illness that makes joining unsafe, certain heart rhythm problems, or reduced heart pumping strength.
  • Have had another cancer, unless it was treated to cure it, has been inactive for at least 2 years, and has a low chance of returning. Past or planned organ or donor stem cell transplants also exclude you.
  • Still have certain side effects from past cancer treatment, or have had serious immune reactions or certain brain-related side effects from treatment.
  • Have certain illnesses where the immune system attacks the body, recent inflammatory illnesses, or a need for long-term medicine to suppress the immune system.
  • Have certain brain or spinal cord problems, pressure on the spinal cord that does not meet study exceptions, active or uncontrolled hepatitis B or C, or HIV that is not well controlled.
  • Have had cancer drugs, radiation, CAR-T cell treatment, major surgery, or a serious injury too recently. Recent steroid doses above the study limit also exclude you.
  • Have an allergy to AZD6621 or its ingredients, a live vaccine within 30 days, or a COVID-19 vaccine within 72 hours before the first study dose.
  • Have already joined this study, help plan or run it, or are unlikely to follow its rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria 1. Capable of giving signed informed consent and complying to the study protocol. 2. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form. 3. ≥ 18 years of age at the time of signing the informed consent form. 4. Participants with: 1. Histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate 2. Surgically or medically castrated, with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) ≤ 28 days before first dose of study intervention. Participants without prior surgical castration must be currently taking and willing to continue LHRH agonist or antagonist therapy throughout the duration of the study intervention. 3. Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing ADT. 4. PSA at screening visit ≥ 1 ng/mL. 5. Provision of baseline fresh or archival tumor biopsy of prostate carcinoma is mandatory. 6. Evidence of disease progression within 6 months prior to screening with at least one of the following: 1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. 2. Radiographic progression of soft tissue disease by RECIST v1.1 criteria with or without PSA progression. 3. Radiographic progression of bone metastasis by PCWG3 criteria with 2 or more documented new bone lesions on a bone scan with or without PSA progression. 7. Part A: Module 1 and Module 2: 1. Part A: Module 1 and Module 2 prior anti-cancer treatment requirements as stated in study protocol 2. Pharmacodynamic backfill cohort(s) only: lesion amenable for biopsy and be willing to undergo biopsy, distinct from any target lesion used in the RECIST v1.1 evaluation, unless there are no other lesions available for biopsy. 8. Part B: Module 1 and Module 2: 1. Part B: Module 1 and Module 2 prior anti-cancer treatment requirements as stated in study protocol. 2. Participants may have received PARP inhibitors or checkpoint inhibitors per local treatment guidelines. 3. Sampling Requirements as stated in study protocol. 9. ECOG PS score of 0 or 1. 10. Minimum life expectancy of \> 12 weeks. 11. Adequate hematological, renal, bone marrow, and liver function as documented in the protocol. 12. Body weight ≥ 35 kg. 13. Male, as assigned at birth, inclusive of all gender identities. 14. Contraceptive use by participants or participant partners as documented in the protocol and consistent with local regulations. Exclusion Criteria 1. 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. 2. One or more of the following: 1. Mean resting corrected QT interval \> 470 ms, 2. History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes. 3. Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives. 4. Inadequate cardiac function of LVEF \< 50% on screening cardiac MUGA or ECHO. 3. 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. 4. 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. 5. History of, or planned organ or allogeneic stem cell transplantation. 6. Unresolved toxicity from prior anti-cancer therapy of CTCAE Grade ≥ 2 (exceptions listed in protocol). 7. History of Grade ≥ 3 CRS or Grade ≥ 2 ICANS based on ASTCT criteria with prior therapy. CRS must be resolved prior to screening. 8. Previous history of hemophagocytic lymphohistiocytosis/ macrophage activation syndrome. 9. 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. 10. Spinal cord compression unless asymptomatic and treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent. 11. CNS pathology (examples in protocol). 12. Active or uncontrolled hepatitis B or C virus infection (exceptions listed in the protocol). 13. Known HIV infection that is not well controlled (definition for HIV infection that is well controlled is listed in protocol). 14. Radiation therapy within 4 weeks of first dose of study intervention (or local or focal radiotherapy within 2 weeks of first dose). 15. Prior anti-cancer drug exposure requirement as stated in study protocol 16. Previous anti-cancer treatment requirements as stated in study protocol 17. Systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent \< 7 days prior to first dose. 18. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose. 19. 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 \- CAR-T cell therapy within the last 6 months prior to enrolment on this study. 20. Participants with a known hypersensitivity to AZD6621 or any of its excipients. 21. Involvement in the planning and/or conduct of the study. 22. Participant is unlikely to comply with study procedures, restrictions, and requirements (as judged by the Investigator). 23. 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. 24. Previous enrolment in the present study.

Study sites (6)

FL

MA

MI

NY

RI