Recruiting
Phase 1

INR731 & ARPIs

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07570979

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INR731

Enzalutamide

Abiraterone

Androgen deprivation therapy (ADT)

Study Details

Brief summary:

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.

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study ID

NCT07570979

Start date

May 25, 2026

Status verified date

Jul, 2026

Completion date

Jun 3, 2030

Anticipated

Primary completion date

Jun 3, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.
  • Participants must have histological and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are eligible as long as the non-adenocarcinoma feature is the minority component.
  • At least 1 metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to Cycle 1 Day 1 (C1D1).
  • Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
  • Ongoing androgen deprivation therapy (ADT) either via orchiectomy and/or ongoing gonadotropin-releasing hormone (GnRH) analog or inhibitor is allowed.
  • Participants must be mCRPC patients who have either progressed on or are not candidates for other SOC. Prior taxane, poly(ADP) ribose polymerase (PARP) inhibitor, and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) are allowed. Combination expansion patients, however, must be 1L mCRPC with no prior treatment in the mCRPC setting. Treatment within the mHSPC setting does not affect eligibility.

Exclusion Criteria:

  • Age < 18 years old.
  • Histological and/or cytological confirmation of non-adenocarcinoma of the prostate.
  • Patients with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT/MRI or bone scan) are not eligible.
  • Patients previously treated with a cereblon-based degrader.
  • Patients who are HIV+ or immune compromised.
  • Use of agents known to prolong QT interval unless they can be permanently discontinued for the duration of the study
  • Treatment with an investigational agent within 7 days (or 5 half-lives, whichever is longer) of the anticipated Cycle 1 Day 1 (C1D1).

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

208 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

INR731

Oral administration

Enzalutamide

Oral administration

Abiraterone

Oral administration

Androgen deprivation therapy (ADT)

Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.

Primary outcome measure

  • Incidence and severity of dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 24 months ]
  • Frequency of dose interruptions and reductions [ Time Frame: Up to approximately 24 months ]
  • Dose intensity [ Time Frame: Up to approximately 24 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75251

Contacts

Pramitha Kondancheri

972-566-3000Pramitha.RarothKondancheri@scri.com

Principal Investigator:

Reva Schneider

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • INR731
  • prostate cancer
  • mCRPC
  • castration resistance
  • androgen receptor pathway inhibitor
  • ARPI
  • abiraterone
  • enzalutamide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-14.