Clinical trial · Interventional
Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer
NCT03888612CI-TRIAL-00087951mCRPCcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARV-110 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARV-110
- description
- Part A: Oral tablet(s), once or twice daily in 28 day cycles Part B: Oral tablet(s), once or twice daily in 28 day cycles
- interventionNames
- Drug: ARV-110
Primary outcomes (6)
- measure
- Part A: Incidence of Dose Limiting Toxicities of ARV-110
- timeFrame
- 28 Days
- description
- First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
- measure
- Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110
- timeFrame
- 28 Days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Part A: * Patients must be male and at least 18 years of age at the time of signing the informed consent. * Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate. * Patients must have progressed on at least 2 prior approved systemic therapies for CRPC (at least one must be abiraterone or enzalutamide). * Patients with progressive mCRPC * Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration). Part B: * Patients must be male and at least 18 years of age at the time of signing the informed consent. * Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate. * Patients must have received at least one but no more than two prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone) for CRPC. * Patients must have received no more than one prior chemotherapy regimen in each of the following settings: castrate sensitive and castrate resistant prostate cancer. * Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration). Part B - Phase 2 Expansion Cohort Subgroup 4 * Patient has received only one prior AR second generation therapy (e.g., abiraterone or enzalutamide) either as treatment for CSPC or CRPC and no more than 1 regimen in CRPC setting. * No prior chemotherapy Exclusion Criteria: Part A: * Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses) * Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug. * Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study * Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug. Part B: * Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses) * Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug. * Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study * Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.
References
Publications (1)
- DERIVEDSnyder LB, Neklesa TK, Willard RR, Gordon DA, Pizzano J, Vitale N, Robling K, Dorso MA, Moghrabi W, Landrette S, Gedrich R, Lee SH, Taylor ICA, Houston JG. Preclinical Evaluation of Bavdegalutamide (ARV-110), a Novel PROteolysis TArgeting Chimera Androgen Receptor Degrader. Mol Cancer Ther. 2025 Apr 2;24(4):511-522. doi: 10.1158/1535-7163.MCT-23-0655. PMID 39670468