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An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer (CINR731A12101)

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 (CINR731A12101)

Moizumi Sanae

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku2@novartis.com

Moizumi Sanae

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

Recruiting

July. 31, 2026

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

- 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.

- 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).

Male

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Experimental: INR731 single agent (Arm A): Drug: INR731 - Oral administration; Drug: Androgen deprivation therapy (ADT) - Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.
Experimental: INR731 in combination with enzalutamide (Arm B): Drug: INR731 - Oral administration; Drug: Enzalutamide - Oral administration; Drug: Androgen deprivation therapy (ADT) - Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.
Experimental: INR731 in combination with abiraterone (Arm C): Drug: INR731 - Oral administration; Drug: Abiraterone - Oral administration; Drug: Androgen deprivation therapy (ADT) - Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.

Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency of dose interruptions and reductions
Dose intensity

June. 10, 2026

No

United States/Australia