Clinical Trials for Prostate Cancer

TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Men with progressive metastatic castration-resistant prostate cancer after one prior second‑generation ARPI (taxane‑naive in Phase II; broader prior therapy allowed in Phase I) are enrolled to receive tulmimetostat, a dual EZH2/EZH1 inhibitor, plus luxdegalutamide (JSB462), a PROTAC androgen receptor degrader, versus investigator’s choice standard care. Key exclusions include prior PRC2 inhibitors, AR degraders, and most radioligand therapy.

ClinicalTrials.gov ID: NCT07206056

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors—including SCLC, NSCLC, ESCC, CRPC, melanoma, HCC, cervical cancer, HNSCC, and select rare cancers—who have progressed after or are intolerant to standard therapies. Patients receive DB-1311, an anti-B7-H3 antibody-drug conjugate linked to a topoisomerase I inhibitor, administered intravenously every 3 weeks.

ClinicalTrials.gov ID: NCT05914116

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with locally advanced or metastatic solid tumors—especially those with Wnt pathway activating mutations such as APC or CTNNB1—including select colorectal, liver, desmoid, and prostate cancers, testing the oral β-catenin:TCF4 inhibitor FOG-001 as monotherapy or in combination with standard regimens (e.g., mFOLFOX-6 plus bevacizumab, nivolumab, or trifluridine/tipiracil plus bevacizumab). Eligible patients must have ECOG 0-1 and no significant bone, CNS, cardiac disease, or active IBD.

ClinicalTrials.gov ID: NCT05919264

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with metastatic castration‑resistant prostate adenocarcinoma after 1–2 prior next‑generation hormonal agents, on continued ADT, are randomized to the CYP11A1 inhibitor opevesostat (MK‑5684) with physiologic steroid replacement as monotherapy or combined with olaparib, docetaxel, or cabazitaxel. Opevesostat blocks steroidogenesis upstream of androgen synthesis to suppress AR signaling; combinations aim to define RP2D and assess antitumor activity.

ClinicalTrials.gov ID: NCT06353386

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Metastatic castration‑resistant prostate adenocarcinoma (ECOG 0–1; measurable or evaluable disease; PSA ≥2) treated with a combination of pasritamig (JNJ‑78278343), a KLK2×CD3 bispecific T‑cell–redirecting antibody, plus JNJ‑95298177 (ARX517), a PSMA‑targeted antibody–drug conjugate with a noncleavable microtubule inhibitor payload. Excludes prior KLK2‑directed therapy, recent T‑cell redirectors or checkpoint inhibitors, and prior PSMA radioligands for most expansion parts; aims to define an RP2CD and assess safety and preliminary activity.

ClinicalTrials.gov ID: NCT07082920

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Men with progressive metastatic castration‑resistant prostate adenocarcinoma after one next‑generation AR pathway inhibitor, ECOG 0–1, receive gedatolisib (investigational pan‑class I PI3K/mTORC1/2 inhibitor) plus darolutamide. Excludes prior PI3K/AKT/mTOR therapy or mCRPC chemo/radiopharmaceuticals; continued ADT required.

ClinicalTrials.gov ID: NCT06190899

Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Men with progressive mCRPC after at least one AR pathway agent, ECOG 0–1, and ongoing castration (no prior PD‑1/PD‑L1 therapy) receive pembrolizumab plus a standard AR pathway inhibitor, randomized to add a single dose of 225Ac-J591. 225Ac-J591 (rosopatamab tetraxetan) is a PSMA-targeted monoclonal antibody radioimmunotherapy delivering alpha-emitting actinium-225 to PSMA-expressing tumor cells.

ClinicalTrials.gov ID: NCT04946370

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Enrolling adult men with metastatic aggressive variant prostate cancer (including small cell/neuroendocrine features, visceral-only disease, lytic bone mets, low-PSA/high-volume disease, elevated LDH/CEA, rapid CR, or TP53/RB1/PTEN loss) and ECOG ≤2, without prior platinum or cabazitaxel for CRPC. Investigational triplet of ADI-PEG20 (pegylated arginine deiminase; depletes extracellular arginine exploiting ASS1 loss) plus carboplatin and cabazitaxel, followed by ADI-PEG20 maintenance.

ClinicalTrials.gov ID: NCT06085729