208 Participants NeededMy employer runs this trial

INR731 for Prostate Cancer

Recruiting at 1 trial location
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to care for myself and do light activities.
* 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).
I am currently receiving androgen deprivation therapy for my condition.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Dose Escalation

Participants receive INR731 as a single agent or in combination with enzalutamide or abiraterone to determine the recommended dose

28 days
Multiple visits for dose escalation monitoring

Treatment - Dose Expansion

Further exploration of safety, tolerability, and preliminary anti-tumor activity at the recommended dose

Up to approximately 24 months
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Abiraterone
  • Enzalutamide
  • INR731

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: INR731 single agent (Arm A)Experimental Treatment2 Interventions
Group II: INR731 in combination with enzalutamide (Arm B)Experimental Treatment3 Interventions
Group III: INR731 in combination with abiraterone (Arm C)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD