Clinical Trials for Prostate Cancer

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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: PSMA PET–positive metastatic castration‑resistant prostate cancer on continuous ADT after ≥1 ARSI; no PSMA‑negative lesions, with Part 3 requiring prior Lu‑177–PSMA (and allowing ≤1 prior taxane). Investigational therapy is Ac‑225 rosopatamab tetraxetan (225Ac‑J591), a PSMA‑targeted alpha‑emitting monoclonal antibody delivered in a single fractionated cycle (Day 1/15) at 45–60 kBq/kg, with randomized dose optimization in PSMA‑RT–naive patients and dose escalation/expansion in those post‑Lu‑177.

ClinicalTrials.gov ID: NCT06549465

A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 metastatic castration-resistant prostate cancer progressing on abiraterone (ECOG 0–1, on continuous ADT, no prior second‑generation AR inhibitor or mCRPC chemotherapy) are randomized to enzalutamide alone versus enzalutamide plus ZEN003694, an oral pan-BET bromodomain inhibitor (BRD2/3/4/BRDT) aiming to suppress AR/MYC-driven transcription. Two predefined cohorts (poor vs good prior abiraterone responders) are included; crossover from control at radiographic progression is allowed.

ClinicalTrials.gov ID: NCT04986423

A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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: PSMA-positive mCRPC after at least one ARPI (and up to two taxanes), no prior PSMA radioligand therapy, randomized to 177Lu-PSMA-617 alone or combined with JSB462 (luxdegalutamide), an oral PROTAC androgen receptor degrader active against LBD resistance mutations. Aims to assess whether adding JSB462 improves antitumor activity and safety versus radioligand alone.

ClinicalTrials.gov ID: NCT07047118

Phase II Trial of Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Selected Solid Tumor Malignancies

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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: Adults with advanced solid tumors after ≥1 prior therapy, enriched for ARID1A-altered cancers, ATM-deficient tumors (including mCRPC), and a post–checkpoint inhibitor endometrial cancer cohort; measurable disease required. Patients receive the ATR inhibitor ceralasertib (monotherapy for BAF250a-negative ARID1A or ATM-loss, ceralasertib + PARP inhibitor olaparib for BAF250a-positive ARID1A, or ceralasertib + anti–PD-L1 durvalumab for endometrial), leveraging DNA damage response targeting and potential synergy with PARP inhibition or immunotherapy.

ClinicalTrials.gov ID: NCT03682289

A Phase 2a Multicenter, Dose-Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 metastatic castration-resistant prostate adenocarcinoma after at least one second-generation AR inhibitor (± prior taxane), castrate and ECOG 0–2, with a lesion accessible for transperineal intratumoral access/biopsy, and without visceral or brain metastases. Treatment involves partial oncolysis of a target lesion followed by intratumoral SV-102, a fixed-dose multi-agent immunotherapy (anti-CTLA-4, anti-PD-1, CD40 agonist, TLR9 agonist) designed to induce in situ vaccination; dose is escalated/optimized across cohorts.

ClinicalTrials.gov ID: NCT06533644

A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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: mCRPC patients with adenocarcinoma after exactly one prior second‑generation ARSI and no taxane in the mCRPC setting receive the CD46‑targeted antibody‑drug conjugate FG‑3246 (FOR46), an MMAE‑conjugated monoclonal antibody, given IV every 3 weeks at randomized doses (1.8, 2.4, or 2.7 mg/kg). Requires recent CRPC‑era tissue, measurable/evaluable disease, and excludes prior CD46 therapy, neuroendocrine histology, >1 ARSI, significant neuropathy, or recent systemic therapy.

ClinicalTrials.gov ID: NCT06842498

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

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: Adults with advanced/metastatic solid tumors (endometrial, gastric, mCRPC, ovarian, colorectal, urothelial, biliary) receive datopotamab deruxtecan (anti‑TROP2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with agents such as capecitabine/5‑FU, bevacizumab ± platinum, prednisone (mCRPC), platinum in urothelial cancer, or bispecific PD‑1/CTLA‑4 (volrustomig) or PD‑1/TIGIT (rilvegostomig) immunotherapies. Key exclusions include active/untreated CNS disease, prior TROP2- or deruxtecan-based ADCs, significant ILD/pneumonitis history, and uncontrolled infections/comorbidities.

ClinicalTrials.gov ID: NCT05489211

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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: Adults with metastatic castration-resistant prostate cancer that has radiographic/PSA progression on abiraterone or enzalutamide (with ongoing ADT) receive tinengotinib combined with their current ARSI (abiraterone/prednisone or enzalutamide). Tinengotinib is an oral spectrum-selective multikinase inhibitor (targets Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, CSF1R) aiming to enhance antitumor activity in this post-ARSI setting.

ClinicalTrials.gov ID: NCT06457919

Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition

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: Adults with PSMA-positive metastatic castration-resistant prostate adenocarcinoma after progression on at least one AR-targeted agent (and up to two prior taxanes or taxane-ineligible) are randomized to lutetium Lu 177 vipivotide tetraxetan alone versus in combination with ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody designed to preserve CTLA-4 recycling and selectively deplete intratumoral Tregs to potentially reduce immune toxicity. Requires ECOG 0–1, castrate testosterone, evidence of progression, and no prior PSMA radioligand therapy or active autoimmune disease.

ClinicalTrials.gov ID: NCT05682443