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Recruiting NCT07570979

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

Phase I Interventional Metastatic Castration-resistant Prostate Cancer (mCRPC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INR731, Enzalutamide, Abiraterone, Androgen deprivation therapy (ADT).
Who it may be relevant to
Registry conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

This is a first-in-human, open-label, phase I, multi-center study which consists of three treatment arms: INR731 single agent (Arm A), and INR731 in combination with enzalutamide (Arm B) or abiraterone (Arm C).

The single agent arm has a dose escalation part followed by a dose expansion part. Once the single agent recommended dose(s) is determined during dose escalation, the study may proceed to dose expansion to further explore safety, tolerability and preliminary anti-tumor activity. The single agent dose expansion part will include a post-standard of care (SOC) metastatic castration resistant prostate cancer (mCRPC) group and patients with time to castration resistance (TTCR) \<12 months.

The combination arms have a dose escalation of INR731 in combination with enzalutamide or abiraterone followed by a dose expansion of INR731 in combination with enzalutamide only. The combination dose escalation will be conducted in patients with mCRPC who have progressed following standard of care (post-SOC). During combination escalation, once the safety and tolerability of INR731 with the combination agent(s) is assessed, the study may proceed to dose expansion. The combination dose expansion part will include first-line (1L) mCRPC patients with no prior treatment in the mCRPC setting.

Interventions

  • Drug INR731
    Oral administration
  • Drug Enzalutamide
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • Overall Response Rate (ORR) [Time frame: Up to approximately 24 months]
  • Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
  • Radiological Progression Free Survival (rPFS) [Time frame: Up to approximately 24 months]
  • Prostate-Specific Antigen 50% response rate (PSA50 rate) [Time frame: Up to approximately 24 months]
  • Area under the plasma concentration-time curve (AUC) of INR731 [Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days.]
  • Maximum plasma concentration (Cmax) of INR731 [Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days.]
  • Time to reach maximum plasma concentration (Tmax) of INR731 [Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days.]
  • Trough concentration (Ctrough) of INR731 [Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days.]
  • Plasma concentrations of study drugs [Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. One cycle = 28 days.]
  • Progression Free Survival (PFS) [Time frame: Up to approximately 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mary Crowley Cancer Research — Dallas
Australia · 1 center
  • Novartis Investigative Site — Melbourne
Japan · 1 center
  • Novartis Investigative Site — Hirakata

Identifiers

NCT: NCT07570979 · CINR731A12101 · 2025-524080-20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗