Clinical Trials for Prostate Cancer

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally 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.

HealthScout AI summary: Eligible patients are adults with unresectable, locally advanced, or metastatic solid tumors who have exhausted standard therapies, good performance status (ECOG 0-1), and adequate organ function. The investigational agent is AGX101, a TM4SF1-targeted antibody-drug conjugate delivering a maytansinoid payload to tumor and tumor vasculature cells.

ClinicalTrials.gov ID: NCT06440005

A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma

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.

HealthScout AI summary: Adults with advanced unresectable or metastatic solid tumors (including a broad range such as ovarian, pancreatic, GI, lung, and more) or relapsed/refractory multiple myeloma who have failed or are intolerant to standard therapies are eligible to receive QXL138AM, a masked anti-CD138 immunocytokine fused to interferon alpha-2a designed for tumor-targeted immune activation.

ClinicalTrials.gov ID: NCT06582017

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing 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.

HealthScout AI summary: This trial enrolls adults with recurrent or metastatic GRPR-expressing solid tumors (including mCRPC, HR+/HER2- breast, colorectal, cervical, melanoma, and NSCLC) who have progressed on at least two prior systemic therapies, and treats them with 212Pb-DOTAM-GRPR1, a radiolabeled peptide that targets the gastrin-releasing peptide receptor (GRPR) to deliver alpha particle radiation directly to tumor cells.

ClinicalTrials.gov ID: NCT05283330

A Phase I, Multicentre, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced 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.

HealthScout AI summary: Adults with advanced, measurable solid tumors and assessable MUC1 and/or HER3 expression are eligible to receive DM002, a bispecific antibody-drug conjugate targeting MUC1 and HER3, given intravenously every three weeks.

ClinicalTrials.gov ID: NCT06751329

An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1/2 Study With Peluntamig (PT217) Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients With NeuRoendocrIne Carcinomas That Are Known to be DLL3 expressinG CancErs (SKYBRIDGE)

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.

HealthScout AI summary: Adults with DLL3-expressing advanced/metastatic neuroendocrine carcinomas (including SCLC, LCNEC, and extrapulmonary NEC; predominant ≥50% neuroendocrine component) receive peluntamig (PT217), a bispecific anti-DLL3/CD47 IgG designed to promote macrophage phagocytosis and ADCC, as monotherapy or combined with carboplatin/etoposide, paclitaxel, and/or atezolizumab. Cohorts include relapsed/refractory disease and line-specific settings such as platinum-sensitive second line and ES-SCLC first-line or post-induction with atezolizumab.

ClinicalTrials.gov ID: NCT05652686

A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced 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.

HealthScout AI summary: Adults with advanced solid tumors harboring AKT1 E17K mutations, including a cohort with HR+/HER2- metastatic breast cancer, receive the oral selective AKT1 E17K allosteric inhibitor ATV-1601 as monotherapy or in combination with fulvestrant. The trial excludes tumors with activating RAS/BRAF mutations and aims to identify dosing and preliminary activity while minimizing AKT2-related metabolic toxicities.

ClinicalTrials.gov ID: NCT07038369

A Phase I Study of Safety, Pharmacokinetic and Efficacy of Orally Administered APG-5918 in Patients With Advanced Solid Tumors or Hematologic Malignancies

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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors or relapsed/refractory non-Hodgkin’s lymphoma (ECOG 0–2) who have exhausted standard options receive once-daily oral APG-5918, an EED inhibitor that allosterically disrupts PRC2 to deplete H3K27me3. Expansion focuses on molecular subsets including EZH2-mutant B‑cell lymphomas, SMARCB1-deficient sarcomas (epithelioid preferred), and castration‑resistant prostate cancer; treated/stable brain mets allowed.

ClinicalTrials.gov ID: NCT05415098

A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 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.

HealthScout AI summary: Adults with metastatic prostate adenocarcinoma (ECOG 0–1) post–second-generation AR therapy and typically post-taxane (or ineligible/refusing), with PARP inhibitor exposure if BRCA1/2-mutated, receive oral RO7656594 (GDC-2992), a heterobifunctional androgen receptor antagonist/degrader via cereblon-mediated proteasomal degradation. Dose escalation and expansion assess safety, PK, and preliminary activity, excluding prior AR degrader exposure and untreated CNS disease.

ClinicalTrials.gov ID: NCT05800665

A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies

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.

HealthScout AI summary: Enrolling adults with ECOG 0–1 who have selected relapsed/refractory cancers: solid tumors (e.g., post–docetaxel/AR-targeted mCRPC or metastatic/unresectable NUT carcinoma) and hematologic malignancies including CMML and intermediate/high-risk myelofibrosis after JAK inhibitor; stable treated brain mets allowed. Investigational therapy is EP31670 (NEO2734), an oral first-in-class dual BET and CBP/p300 inhibitor given intermittently as monotherapy (solid tumors/CMML) or combined with ruxolitinib or momelotinib in myelofibrosis.

ClinicalTrials.gov ID: NCT05488548

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

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: Enrolling adults with metastatic rare genitourinary cancers across multiple histologic cohorts (e.g., small cell/neuroendocrine bladder, variant urothelial, penile, sarcomatoid/unclassified RCC, collecting duct, renal medullary, urethral; including a bone-only GU cohort), with up to two prior lines allowed (cohort-specific exceptions. Patients receive cabozantinib (MET/VEGFR2/AXL multi-kinase inhibitor) plus nivolumab (PD-1) and ipilimumab (CTLA-4) for up to 2 years.

ClinicalTrials.gov ID: NCT03866382