Clinical Trials for Prostate Cancer

A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors

No known activity

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

TrialFetch AI summary: Adults with ECOG 0–1 and measurable advanced selected solid tumors, including SCLC, extrapulmonary high-grade neuroendocrine/small-cell carcinomas, NSCLC, prostate, ovarian, renal, HNSCC, hepatic, gastric, and triple-negative breast cancers, after progression/relapse/intolerance to at least one standard systemic therapy. All patients receive dose-escalated oral EXS74539/REC-4539 monotherapy, a selective reversible LSD1/KDM1A epigenetic inhibitor, to define safety and MTD with preliminary efficacy assessment.

ClinicalTrials.gov ID: NCT07517198

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

No known activity

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

TrialFetch AI summary: Adults with unresectable or metastatic advanced solid tumors, particularly MSI-H/dMMR tumors, receive oral EIK1005, a Werner syndrome helicase inhibitor intended to exploit synthetic lethality in MSI-H cancers, after progression/intolerance of standard therapy or in dose-optimization cohorts. The study tests EIK1005 monotherapy and dose escalation of EIK1005 plus pembrolizumab in MSI-H/dMMR advanced solid tumors.

ClinicalTrials.gov ID: NCT07262619

A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer

No known activity

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

TrialFetch AI summary: Enrolls men with metastatic castration-resistant prostate adenocarcinoma, generally after prior androgen receptor pathway inhibitor therapy and limited/required prior taxane exposure depending on cohort, with key exclusions including prior T-cell engager/CAR-T or radioligand therapy. All participants receive single-agent JANX014, an investigational tumor-activated PSMA × CD3 T-cell engager designed to redirect T cells against PSMA-expressing prostate cancer cells while limiting systemic T-cell activation.

ClinicalTrials.gov ID: NCT07545811

Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer

No known activity

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

TrialFetch AI summary: Enrolls men with metastatic castration-resistant prostate cancer progressing after at least one novel androgen receptor–targeted agent, with ECOG 0–1 and no requirement for RECIST-measurable disease. All patients receive oral (R)-9bMS/mahatinib, an investigational ACK1/TNK2 tyrosine kinase inhibitor intended to suppress AR/AR-V7 signaling, in dose escalation/expansion to define safety and the recommended phase 2 dose.

ClinicalTrials.gov ID: NCT06705686

An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer

No known activity

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

TrialFetch AI summary: Adults with radiographically metastatic castration-resistant prostate adenocarcinoma, including heavily pretreated patients in escalation/monotherapy cohorts and first-line mCRPC patients in combination expansion, receive oral INR731, an investigational agent with undisclosed target/mechanism, alone or with continued ADT plus enzalutamide or abiraterone. The study focuses on safety, dose finding, pharmacokinetics, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT07570979

A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

No known activity

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

TrialFetch AI summary: Enrolls adults with PSMA-PET–positive mCRPC after progression on one prior ARPI, with Phase II focused on taxane-naive patients and excluding prior PSMA-targeted/radioligand therapy. Treatment evaluates oral AMO959, an investigational DNA-PK inhibitor intended to radiosensitize tumors, combined with 177Lu-PSMA-617, with or without continuous abiraterone or enzalutamide; Phase II compares AMO959 plus 177Lu-PSMA-617 plus ARPI versus 177Lu-PSMA-617 plus ARPI.

ClinicalTrials.gov ID: NCT07226986

Phase I/II Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)

No known activity

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

TrialFetch AI summary: Adults with ECOG 0–1 and previously treated metastatic castration-resistant prostate adenocarcinoma or metastatic invasive breast cancer receive nine infusions of autologous fresh peripheral blood mononuclear cells armed ex vivo with HER2Bi. This anti-CD3 × anti-HER2 bispecific antibody redirects CD3-positive T cells against HER2-expressing tumor cells without prolonged T-cell expansion.

ClinicalTrials.gov ID: NCT07441889

A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors

No known activity

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

TrialFetch AI summary: Adults with measurable advanced or metastatic solid tumors that have progressed on, or are unsuitable or intolerant of, standard therapy receive once-daily oral SHY-ONC6. SHY-ONC6 is a small-molecule proteasome inhibitor targeting selected AAA+ ATPases in the 19S regulatory particle to disrupt ubiquitinated protein processing and promote apoptosis.

ClinicalTrials.gov ID: NCT07705334

BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer

No known activity

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

TrialFetch AI summary: Adults with progressive mCRPC, ECOG 0–1, and limited prior AR pathway inhibitor/taxane therapy are enrolled in cohorts based on prior 177Lu-PSMA-617 exposure. Patients receive IV [225Ac]Ac-AKY-2519, a B7-H3/CD276-targeted miniprotein radiopharmaceutical that delivers alpha radiation after tumor internalization, with optional [64Cu]Cu-AKY-2519 imaging for biodistribution and dosimetry.

ClinicalTrials.gov ID: NCT07581184

Phase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer

No known activity

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

TrialFetch AI summary: Adults with progressive metastatic castration-resistant prostate adenocarcinoma or neuroendocrine-differentiated prostate cancer after androgen-receptor pathway inhibition and other specified prior therapies receive AZD8359 at escalating or selected dose levels and schedules. AZD8359 is a STEAP2-targeted, CD8-biased T-cell engager designed to direct cytotoxic CD8+ T cells against STEAP2-expressing prostate cancer cells.

ClinicalTrials.gov ID: NCT07529717