Clinical Trials for Prostate Cancer

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic 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: Enrolls adults with metastatic prostate adenocarcinoma (mainly mCRPC after prior ARPI ± docetaxel; one cohort includes mHSPC with non-castrate testosterone and bone-only disease) to receive the KLK2×CD3 bispecific T‑cell engager pasritamig (JNJ‑78278343) combined with either cetrelimab (PD‑1 inhibitor), a taxane (docetaxel or cabazitaxel), or an ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone/prednisone). Open-label cohorts assess safety and preliminary activity to define recommended regimens; ECOG 0–1 and measurable/evaluable disease required.

ClinicalTrials.gov ID: NCT05818683

A Phase I and Randomized Phase II Trial of Radium-223 Dichloride, M3814, &Amp; Avelumab in Advanced Metastatic Castrate-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.

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 with bone-predominant disease (no visceral metastases), previously treated with AR-targeted therapy and/or taxane, are randomized to radium-223 alone versus radium-223 plus peposertib (M3814; oral DNA-PK inhibitor) versus radium-223 plus peposertib plus avelumab (anti–PD-L1). Key exclusions include active autoimmune disease requiring immunosuppression and concurrent abiraterone with radium-223; ECOG 0–1 (phase I) or 0–2 (phase II) required.

ClinicalTrials.gov ID: NCT04071236

Dynamic Investigator Initiated Enterprise (DIVINE) in 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.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Adults with metachronous recurrent oligometastatic hormone-sensitive prostate cancer (≤5 mets, ≥1 extra-pelvic) are randomized to SBRT alone versus SBRT plus 6 months of ADT and an androgen receptor pathway inhibitor (abiraterone/prednisone, apalutamide, darolutamide, or enzalutamide), then observation. ADT options include LHRH agonists/antagonists or an investigational long-acting GnRH antagonist depot (Debio 4228/degarelix), with the trial assessing whether short-course systemic intensification improves modified radiographic PFS.

ClinicalTrials.gov ID: NCT06378866

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced 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: Adults with metastatic castration‑resistant prostate adenocarcinoma (PCWG3; measurable/evaluable disease, PSA ≥2, on castration, ECOG 0–1; excludes active autoimmune disease requiring immunosuppression and recent major CV/CNS events) receive combination immunotherapy with pasritamig (KLK2×CD3 T‑cell–redirecting bispecific) plus JNJ‑87189401 (PSMA×CD28 costimulatory bispecific) to evaluate safety and preliminary activity. Suitable for mCRPC including those with small cell/neuroendocrine features (but not pure small cell/large cell NE).

ClinicalTrials.gov ID: NCT06095089

Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy

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.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Men with PSMA PET–positive biochemical recurrence after definitive local therapy, no visceral/bone mets, testosterone >100 ng/dL, and PSA DT <12 months are randomized to short-course enzalutamide without ADT versus enzalutamide plus PDS01ADC (NHS-IL12), an IL‑12 immunocytokine that targets exposed histones in necrotic tumor regions to deliver IL‑12 and stimulate NK/T‑cell activity. Designed to test whether adding PDS01ADC prolongs PSA control; retreatment with enzalutamide alone allowed upon PSA return to baseline.

ClinicalTrials.gov ID: NCT06096870

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)

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 imaging-confirmed mCRPC who have progressed after at least one potent AR pathway inhibitor; excludes small cell/neuroendocrine histology and liver metastases. Evaluates pocenbrodib, an oral CBP/EP300 bromodomain inhibitor that suppresses AR/AR‑variant transcription, as monotherapy and in combination with abiraterone, olaparib, or 177Lu‑PSMA‑617.

ClinicalTrials.gov ID: NCT06785636

A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With 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.

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 with advanced or metastatic ER+/HER2- breast cancer who have progressed after endocrine therapy and a CDK4/6 inhibitor, as well as selected patients with castration-resistant prostate cancer or non–small-cell lung cancer refractory to standard treatments. Participants receive PF-07248144, a selective KAT6A/B histone acetyltransferase inhibitor, as monotherapy or in combination with endocrine therapy or other investigational agents.

ClinicalTrials.gov ID: NCT04606446

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

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: This trial enrolls adults with relapsed or refractory small cell lung cancer, metastatic castration-resistant prostate cancer post-abiraterone/enzalutamide, or follicular lymphoma to receive mevrometostat, a selective oral EZH2 inhibitor, as monotherapy or in combination with standard of care therapies. Treatment assignment varies by disease type and prior therapy, with some arms randomizing mCRPC patients to mevrometostat plus standard of care versus standard of care alone.

ClinicalTrials.gov ID: NCT03460977

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

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: This trial enrolls adults with advanced or metastatic solid tumors—including breast, ovarian, prostate, pancreatic (HRR-mutated), IDH1/2-mutant glioma, and other selected solid cancers—who have progressive disease and good performance status, testing the selective PARP1 inhibitor AZD9574 as monotherapy or in combination with temozolomide, trastuzumab deruxtecan, or datopotamab deruxtecan. Eligibility may require specific genetic or molecular features depending on tumor type and study module.

ClinicalTrials.gov ID: NCT05417594

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study

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: This trial enrolls adults with advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329