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RecruitingPhase 1 / Phase 2

A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC

PATHWAY: A Phase 1b/2a, Multicenter, Open- Label Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests doses of pocenbrodib, alone or with darolutamide, to check safety and look for early signs that it fights cancer. It is for adults with prostate cancer that has spread and keeps growing despite treatment to lower testosterone.

This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • A tissue test confirms prostate adenocarcinoma, a type of prostate cancer.
  • Scans show that the cancer has spread. Scans done within 56 days before screening may be used.
  • For phase 2a only: Have received at least 2 treatment cycles of PLUVICTO.
  • For phase 2a only: Have had 1 prior course of an androgen receptor pathway inhibitor (ARPI), a drug that blocks male hormone signals.
  • For phase 2a only: Have not had chemotherapy for prostate cancer that has spread and resists treatment to lower testosterone.

Who can't join

  • The most recent prostate biopsy shows current or past evidence of small cell or neuroendocrine cancer, which are specific cancer types.
  • A biopsy confirms cancer has spread to the liver, or scans show liver spots larger than 1 cm that look like cancer spread.
  • Have used chemotherapy, an experimental drug, or another cancer drug too close to the first study dose. The waiting period is 14 days or 5 drug half-lives, whichever is shorter. A half-life is the time it takes the body to clear half of a drug.
  • Have a serious health, mental health, family, or location-related issue that the study doctor thinks could make participation difficult or treatment too risky.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

1b / 2a Inclusion 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 1b / 2a Exclusion Criteria: 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 Cycle 1 Day 1 or 5 half-lives (whichever is shorter). 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 complications. 2a only -key inclusion criteria: 1. Must have received at least 2 cycles of PLUVICTO® 2. 1 line of prior any ARPI therapy 3. No prior chemotherapy for mCRPC

Study sites (19)

CA

CO

FL

GA

IL

IN

LA

MD

MI

MO

NC

  • Duke University medical center · Durham, NC 27710Blayne Carney · Study contact · 9196608015Andrew Armstrong, MD · Principal investigatorMore trials in Durham

NE

NY

OH

TX

VA