What this study is
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.
What's being tested
- INR731
Intervention · DRUG
- Enzalutamide
Intervention · DRUG
- Abiraterone
Intervention · DRUG
- Androgen deprivation therapy (ADT)
Intervention · DRUG
Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.
All of INR731, Enzalutamide, Abiraterone
Oral administration
Study details
- 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
- Sponsor
- Novartis Pharmaceuticals
- Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Enrolling
- 208 people
- Starts
- 2026-05-25
- Est. completion
- 2030-06-03
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (13)
13 openMass General Hospital
Boston, Massachusetts, United States
- Nadia Kelley · Contactnkelley4@mgh.harvard.edu
- Xin Gao · Principal investigator
RecruitingMary Crowley Cancer Research
Dallas, Texas, United States
- Pramitha Kondancheri · Contact+1 972 566 3000Pramitha.RarothKondancheri@scri.com
- Reva Schneider · Principal investigator
Recruiting
11 sites outside the US
Novartis Investigative Site
Melbourne, Victoria, Australia
RecruitingNovartis Investigative Site
Toronto, Ontario, Canada
RecruitingNovartis Investigative Site
Montreal, Quebec, Canada
RecruitingNovartis Investigative Site
Würzburg, Bavaria, Germany
RecruitingNovartis Investigative Site
Dresden, Saxony, Germany
RecruitingNovartis Investigative Site
Milan, MI, Italy
RecruitingNovartis Investigative Site
Hirakata, Osaka, Japan
RecruitingNovartis Investigative Site
Seoul, South Korea
RecruitingNovartis Investigative Site
Seoul, South Korea
RecruitingNovartis Investigative Site
Madrid, Spain
RecruitingNovartis Investigative Site
Valencia, Spain
Recruiting
Study team
Sponsor
Novartis Pharmaceuticals
Study ID CINR731A12101
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.