CompletedPhase 1

Trial of ARV-110 and Abiraterone in Participants With Metastatic Prostate Cancer

United States45 participantsStarted 2022-05-13

Plain-language summary

Phase 1b study to assess the combination of ARV-110 (bavdegalutamide) and abiraterone in participants with metastatic prostate cancer with rising PSA values on abiraterone.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
✓. Ongoing treatment with stable doses of abiraterone (on an empty stomach) and a concomitant corticosteroid for mCRPC or for metastatic castration sensitive prostate cancer (mCSPC) until Cycle 1, Day 1 (C1D1).
✓. Recent Prostate-specific antigen (PSA) values must demonstrate:
✓. Rising PSAs at least 16 weeks after initiation of abiraterone
✓. At least 2 PSA values that are higher than the PSA nadir on abiraterone, measured at a minimum of 1 week apart . The screening PSA for this study may be used as the 2nd PSA value.
✓. No known radiographic evidence of disease progression while receiving abiraterone and clinically benefitting at the time of consent. If there is radiographic disease progression during screening, the participant may be considered eligible if, in the judgement of the investigator, the participant is clinically benefitting from abiraterone.
✓. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (surgical or medical castration).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

✕. Previously treated with enzalutamide, apalutamide, darolutamide or experimental therapies (e.g., protein degraders or inhibitors) directed at the androgen receptor.
✕. Treatment with any chemotherapy, investigational agents, immunotherapy, or hormonal therapy other than gonadotropin-releasing hormone (GnRH) agonists within 28 days of the start of treatment on protocol.
✕. Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow.
✕. Participants taking agents that are either a) sensitive P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) substrates, or Cytochrome P450 3A4 (CYP3A4) substrates, b) P-gp, BCRP, CYP3A4, or CYP2D6 substrates that have a narrow therapeutic index, c) strong CYP3A4 inhibitors or inducers, or d) any other prohibited and/or restricted medications described in the protocol.
✕. Major surgery (as judged by the Investigator) within 4 weeks of first dose of study drug.
✕. Untreated brain metastases or brain metastases requiring steroids
✕. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
✕. Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class II, III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant episode of thromboembolic disease.

What they're measuring

Safety Lead-in: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

Timeframe: Baseline (Day 1) up to Day 28

Safety Lead-in: Recommended Phase 2 Dose (RP2D) of Bavdegalutamide

Timeframe: Baseline (Day 1) up to Day 28

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs

Timeframe: From Day 1 of study treatment in Safety lead-in up to 30 days after end of study treatment (assessed up to approximately 111.57 weeks)

Trial details

NCT IDNCT05177042

SponsorArvinas Androgen Receptor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-02

Results submitted2026-04-07

View on ClinicalTrials.gov More Prostate Cancer Metastatic trials

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
✓. Ongoing treatment with stable doses of abiraterone (on an empty stomach) and a concomitant corticosteroid for mCRPC or for metastatic castration sensitive prostate cancer (mCSPC) until Cycle 1, Day 1 (C1D1).
✓. Recent Prostate-specific antigen (PSA) values must demonstrate:
✓. Rising PSAs at least 16 weeks after initiation of abiraterone
✓. At least 2 PSA values that are higher than the PSA nadir on abiraterone, measured at a minimum of 1 week apart . The screening PSA for this study may be used as the 2nd PSA value.
✓. No known radiographic evidence of disease progression while receiving abiraterone and clinically benefitting at the time of consent. If there is radiographic disease progression during screening, the participant may be considered eligible if, in the judgement of the investigator, the participant is clinically benefitting from abiraterone.
✓. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (surgical or medical castration).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

✕. Previously treated with enzalutamide, apalutamide, darolutamide or experimental therapies (e.g., protein degraders or inhibitors) directed at the androgen receptor.
✕. Treatment with any chemotherapy, investigational agents, immunotherapy, or hormonal therapy other than gonadotropin-releasing hormone (GnRH) agonists within 28 days of the start of treatment on protocol.
✕. Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow.
✕. Participants taking agents that are either a) sensitive P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) substrates, or Cytochrome P450 3A4 (CYP3A4) substrates, b) P-gp, BCRP, CYP3A4, or CYP2D6 substrates that have a narrow therapeutic index, c) strong CYP3A4 inhibitors or inducers, or d) any other prohibited and/or restricted medications described in the protocol.
✕. Major surgery (as judged by the Investigator) within 4 weeks of first dose of study drug.
✕. Untreated brain metastases or brain metastases requiring steroids
✕. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
✕. Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class II, III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant episode of thromboembolic disease.

What they're measuring

Safety Lead-in: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

Timeframe: Baseline (Day 1) up to Day 28

Safety Lead-in: Recommended Phase 2 Dose (RP2D) of Bavdegalutamide

Timeframe: Baseline (Day 1) up to Day 28

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs

Timeframe: From Day 1 of study treatment in Safety lead-in up to 30 days after end of study treatment (assessed up to approximately 111.57 weeks)