A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer

Part of paid clinical trials in Dallas, Texas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07570979
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INR731 — DRUG
    Oral administration
  • Enzalutamide — DRUG
    Oral administration
  • Abiraterone — DRUG
    Oral administration
  • Androgen deprivation therapy (ADT) — DRUG
    Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.

Study Details

The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.

Key Dates

Start date
May 25, 2026
Status verified
May 2026
Primary completion
Jun 3, 2030
Completion
Jun 3, 2030

Study Design

Enrollment
208 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: INR731 single agent (Arm A)
    The dose escalation part with single agent INR731 may be followed by a dose expansion part.
  • Experimental: INR731 in combination with enzalutamide (Arm B)
    The dose escalation part with INR731 in combination with enzalutamide may be followed by a dose expansion part.
  • Experimental: INR731 in combination with abiraterone (Arm C)
    Dose escalation of INR731 in combination with abiraterone.

Primary Outcome Measure

Incidence and severity of dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (1)

FacilityCityStateZIPSite coordinators
Mary Crowley Cancer ResearchDallasTexas75251
Pramitha Kondancheri
[email protected]
972-566-3000
Reva Schneider (PRINCIPAL_INVESTIGATOR)

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By research site
Mary Crowley Cancer Research· Dallas, TX

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