Clinical Trials for Prostate Cancer

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

A Phase I/II Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or 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 metastatic prostate adenocarcinoma progressing during or after their most recent therapy, with ECOG 0–1 and ongoing androgen deprivation, receive single-agent GDC-1261 in dose-escalation or expansion cohorts. GDC-1261 is an investigational anticancer agent with an undisclosed target and mechanism of action.

ClinicalTrials.gov ID: NCT07567846

A Phase 1b/2 Study of ASP388B as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable 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 locally advanced unresectable or metastatic HNSCC, ESCC, mCRPC, squamous NSCLC, or SCLC receive ASP388B, an investigational antibody–drug conjugate with an undisclosed target, as monotherapy. Previously untreated recurrent/metastatic HNSCC or ESCC cohorts receive ASP388B with pembrolizumab and platinum/5-fluorouracil chemotherapy.

ClinicalTrials.gov ID: NCT07730021

Phase 1/2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma

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 metastatic castration-resistant prostate cancer after at least two systemic treatment lines or metastatic clear-cell renal cell carcinoma progressing after a PD-1/PD-L1–containing regimen receive investigational REGN15505, a PSMA×4-1BB antibody, alone or with cemiplimab (anti-PD-1) or REGN4336 (an investigational PSMA×CD3 T-cell–engaging antibody).

ClinicalTrials.gov ID: NCT07594106