Clinical Trials for Prostate Cancer

A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With 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: This study enrolls men with metastatic castration-resistant prostate adenocarcinoma progressing despite androgen-deprivation therapy and at least one potent androgen-receptor pathway inhibitor. Patients receive once-daily oral FX-111, an investigational cereblon-recruiting degrader of active androgen receptor, while continuing androgen-deprivation therapy when required.

ClinicalTrials.gov ID: NCT07719361

A Phase 1 First-In-Human Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of ML261, an Autologous Anti-DLL3 CAR + CARD11-PIK3R3 Fusion T Cell Therapy, in Participants With Relapsed/Refractory Small Cell Lung Cancer or Select Neuroendocrine Carcinomas

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, advanced or metastatic DLL3-positive relapsed/refractory small-cell lung cancer or select high-grade neuroendocrine carcinomas after at least one standard systemic therapy receive ML261, an autologous DLL3-targeted CAR T-cell therapy engineered with a CARD11–PIK3R3 fusion protein to enhance T-cell signaling and persistence.

ClinicalTrials.gov ID: NCT07488923

A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced 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: Patients with metastatic prostate adenocarcinoma, including small-cell or neuroendocrine features, that has progressed after at least one novel androgen receptor–targeted therapy receive intravenous JNJ-98768111. This investigational antibody–drug conjugate targets human kallikrein-2 to deliver a cytotoxic payload; dosing is escalated, then expanded at selected regimens.

ClinicalTrials.gov ID: NCT07746713

Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors

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.

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 advanced selected solid tumors who have exhausted or are ineligible for standard treatment receive oral TT-10 (PORT-6), an adenosine A2A receptor antagonist, oral TT-4 (PORT-7), an adenosine A2B receptor antagonist, or both. Eligible tumor types vary by cohort and include RCC, CRPC, NSCLC, head and neck, colorectal, endometrial, and ovarian cancers.

ClinicalTrials.gov ID: NCT04969315

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

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.

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 metastatic or unresectable cancer, ECOG 0–1, and no suitable standard treatment option may receive oral NX-1607, a CBL-B inhibitor intended to enhance T-cell antitumor activity. Selected tumor cohorts receive NX-1607 with paclitaxel.

ClinicalTrials.gov ID: NCT05107674

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

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.

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 recurrent or metastatic GRPR-expressing mCRPC, HR-positive/HER2-negative breast cancer, colorectal cancer, cervical cancer, cutaneous melanoma, or NSCLC are eligible if they have a lesion with uptake greater than liver on GRPR imaging; recurrent disease must have progressed after at least two systemic therapies. Participants receive up to four cycles of investigational ²¹²Pb-DOTAM-GRPR1, a GRPR-targeted radiopharmaceutical that delivers DNA-damaging alpha radiation.

ClinicalTrials.gov ID: NCT05283330

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

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.

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 advanced or metastatic cancer after progression on, intolerance of, or lack of benefit from standard therapy receive oral AMXI-5001 twice daily as monotherapy. AMXI-5001 is an investigational dual inhibitor of PARP1/2-mediated DNA repair and tubulin polymerization.

ClinicalTrials.gov ID: NCT04503265

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)

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.

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 advanced or metastatic small-cell lung cancer, pulmonary large-cell neuroendocrine carcinoma, or extrapulmonary neuroendocrine carcinoma are eligible according to cohort-specific prior treatment criteria. Peluntamig, an investigational DLL3/CD47-targeting bispecific antibody, is given alone or with carboplatin/etoposide, paclitaxel, atezolizumab, or carboplatin/etoposide plus atezolizumab.

ClinicalTrials.gov ID: NCT05652686

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

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.

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 and ECOG 0–1 who have received a second-generation androgen receptor–targeted therapy and generally a taxane receive oral RO7656594 (GDC-2992). This investigational drug is designed to inhibit the androgen receptor and recruit cereblon to promote its degradation.

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

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.

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: Patients with relapsed or refractory castration-resistant prostate cancer, unresectable or metastatic NUT carcinoma, chronic myelomonocytic leukemia, myelofibrosis, or selected other advanced cancers receive oral EP31670, an investigational dual BET and CBP/p300 inhibitor. EP31670 is given alone in the initial cohorts; patients with intermediate- or high-risk myelofibrosis and inadequate or lost response to a JAK inhibitor receive it with ruxolitinib or momelotinib.

ClinicalTrials.gov ID: NCT05488548