RECRUITING

Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617

Conditions

mCRPC (Metastatic Castration-resistant Prostate Cancer)Genital Neoplasms, Male Urogenital Neoplasms Urogenital Cancers Prostatic Diseases Prostatic Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,Procenbrodib castration resistant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with Abiraterone acetate, Olaparib or 177Lu-PSMA-617 in patients with metastatic castration-resistant prostrate cancer (mCRPC).

Official Title

A Phase 1b/2a, MultiCenter, Open- Label Study of Pocenbrodib as Monotherapy or in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Quick Facts

Study Start:2025-02-07

Study Completion:2029-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06785636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥18 years of age 2. Histologic documentation of prostate adenocarcinoma 3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable	1. Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy 2. Any liver metastases confirmed by biopsy or evidence of lesions \>1 cm consistent with liver metastases on imaging 3. Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Screening or 5 half-live20. 4. Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complicationss from the last dose (whichever is shorter)

Inclusion Criteria

Exclusion Criteria

1. ≥18 years of age
2. Histologic documentation of prostate adenocarcinoma
3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable

1. Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy
2. Any liver metastases confirmed by biopsy or evidence of lesions \>1 cm consistent with liver metastases on imaging
3. Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Screening or 5 half-live20.
4. Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complicationss from the last dose (whichever is shorter)

Contacts and Locations

Study Contact

Michael Maitland, MD

CONTACT

708-232-3791

prostatecancer@pathos.com

Study Locations (Sites)

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

United States

Oncology Consultants

Houston, Texas, 77030

United States

NEXT Oncology - Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Pathos AI, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-07

Study Completion Date2029-04-30

Study Record Updates

Study Start Date2025-02-07

Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,
Procenbrodib
castration resistant

Additional Relevant MeSH Terms

mCRPC (Metastatic Castration-resistant Prostate Cancer)
Genital Neoplasms, Male
Urogenital Neoplasms
Urogenital Cancers
Prostatic Diseases
Prostatic Neoplasms
Male Urogenital Diseases
Neoplasms
Neoplasms by Site
Prostate Cancer