NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07570979

RecruitingPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions: INR731, Enzalutamide, Abiraterone, Androgen deprivation therapy (ADT)

Countries: United States, Australia, Japan

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (3)

Dallas, Texas, United States
Melbourne, Victoria, Australia
Hirakata, Osaka, Japan