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Clinical Trials for Prostate Cancer

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There are 207 active trials for advanced/metastatic prostate cancer.

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207 trials meet filter criteria.

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No known activity More information High burden on patient More information
Sponsor: SystImmune Inc. (industry) Phase: 1 Start date: April 28, 2025

TrialFetch AI summary: Adults with previously treated, locally advanced/metastatic small cell lung cancer or other neuroendocrine tumors (e.g., LCNEC, NEPC, high‑grade GI‑NET, Merkel cell) receive BL‑M14D1, an investigational DLL3‑targeted antibody–drug conjugate with a topoisomerase I inhibitor payload, given IV every 21 days. Suitable for ECOG 0–1 patients post‑standard therapy (SCLC requires prior platinum); excludes prior topo‑I ADCs, significant cardiac/QTc issues, ILD/pneumonitis, active CNS disease, and uncontrolled infections.

ClinicalTrials.gov ID: NCT07080242

No known activity More information High burden on patient More information
Sponsor: AstraZeneca (industry) Phase: 1/2 Start date: Sept. 30, 2025

TrialFetch AI summary: Adults with metastatic castration‑resistant prostate adenocarcinoma (ECOG 0–1) after progression on ADT receive AZD6621 monotherapy, a multispecific T‑cell–engaging antibody targeting STEAP2 on tumor cells and CD3/CD8 to preferentially activate CD8+ T cells; two administration routes are explored with dose escalation and expansion. Key exclusions include significant cardiac disease/QT prolongation, uncontrolled autoimmune disease, prior severe CRS/ICANS, active CNS disease, and recent cellular therapy.

ClinicalTrials.gov ID: NCT07192614

No known activity More information High burden on patient More information
Sponsor: AstraZeneca (industry) Phase: 1/2 Start date: Oct. 1, 2025

TrialFetch AI summary: Adults with metastatic castration‑resistant prostate adenocarcinoma (ECOG 0–1) with documented progression and adequate organ function receive AZD0516, a STEAP2‑targeted antibody–drug conjugate delivering an exatecan topoisomerase I inhibitor, either as monotherapy or combined with AZD9574 (palacaparib), a selective PARP1 inhibitor. Requires available tumor tissue; excludes prior STEAP2‑targeted therapy and significant CNS, pulmonary, infectious, or cardiovascular comorbidities.

ClinicalTrials.gov ID: NCT07181161

No known activity More information High burden on patient More information
Sponsor: K36 Therapeutics, Inc. (industry) Phase: 1 Start date: Oct. 8, 2025

TrialFetch AI summary: Adult men with metastatic castration-resistant prostate cancer after at least one AR pathway inhibitor, ECOG 0–1, receive oral KTX-2001 (first-in-class NSD2 histone methyltransferase inhibitor targeting H3K36me2) as monotherapy or combined with darolutamide 600 mg BID. Excludes unstable CNS disease and significant cardiac/infection risks; aims to establish safety, PK/PD, and preliminary activity to define MTD/RP2D.

ClinicalTrials.gov ID: NCT07103018

No known activity More information High burden on patient More information
Sponsor: Novartis Pharmaceuticals (industry) Phase: 1 Start date: Oct. 16, 2025

TrialFetch AI summary: Adults with DLL3-expressing advanced solid tumors, including previously treated SCLC or LCNEC (dose escalation) and expansion cohorts of SCLC (≤2 prior lines), de novo or treatment-emergent NEPC, and GEP-NEC; some cohorts require demonstrable uptake on 111In-ETN029 SPECT. Single-arm therapy with 225Ac-ETN029, a DLL3-targeted alpha-emitting radiopharmaceutical delivering actinium-225 to tumor cells, with optional 111In-ETN029 imaging/dosimetry.

ClinicalTrials.gov ID: NCT07006727

No known activity More information High burden on patient More information
Sponsor: Novartis Pharmaceuticals (industry) Phase: 1/2 Start date: Dec. 29, 2025

TrialFetch AI summary: Enrolls adults with advanced malignancies, primarily HR+/HER2− advanced breast cancer that has progressed after endocrine therapy plus a CDK4/6 inhibitor (phase II limited to ≤2 prior endocrine lines for advanced disease and no prior chemotherapy/ADC in the advanced setting), with additional phase I cohorts for CCNE1-amplified solid tumors and metastatic castration-resistant prostate cancer. Patients receive the first-in-human investigational agent GVV858 (target/mechanism not publicly specified) as monotherapy or combined with endocrine therapy—fulvestrant (and letrozole in phase I), with phase II evaluating two GVV858 dose regimens plus fulvestrant.

ClinicalTrials.gov ID: NCT07288359

No known activity More information High burden on patient More information
Sponsor: Arsenal Biosciences, Inc. (industry) Phase: 1/2 Start date: Jan. 9, 2026

TrialFetch AI summary: Enrolls adults with progressive metastatic castration-resistant prostate adenocarcinoma after at least one prior novel androgen receptor pathway inhibitor, requiring PSMA-positive disease on PSMA PET (with RECIST-measurable disease or evaluable disease with PSA ≥1 ng/mL) and no CNS metastases. Patients undergo leukapheresis and receive a single IV infusion of AB-3028, an autologous logic-gated engineered T-cell therapy designed to activate only with PSMA plus a second priming antigen to improve tumor selectivity and limit on-target/off-tumor toxicity.

ClinicalTrials.gov ID: NCT07285694

No known activity More information High burden on patient More information
Sponsor: Daiichi Sankyo (industry) Phase: 1 Start date: Nov. 4, 2025

TrialFetch AI summary: Adults with advanced/metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer (ECOG 0–1; ECOG 2 allowed if due to cancer pain), with the mCRPC cohort requiring prior androgen receptor pathway inhibitor exposure and at least one prior chemotherapy line or ineligibility/refusal, receive oral DS9051b tablet monotherapy. This dose-escalation study is primarily assessing safety/DLTs and establishing the recommended expansion dose while looking for preliminary antitumor activity; DS9051b’s target/mechanism has not been publicly specified.

ClinicalTrials.gov ID: NCT07189403

No known activity More information High burden on patient More information
Sponsor: Conjupro Biotherapeutics, Inc. (industry) Phase: 1 Start date: Feb. 20, 2026

TrialFetch AI summary: Adults with advanced/unresectable or metastatic solid tumors that have progressed after, are intolerant to, or lack standard systemic options (ECOG 0–1; measurable disease; excluding prior B7-H3–targeted therapy, prior topoisomerase inhibitor ADCs, significant ILD/pneumonitis, uncontrolled infection, or active/untreated CNS metastases). Patients receive SYS6043, an IV q3-week B7-H3 (CD276)–targeted antibody–drug conjugate delivering a cytotoxic payload to B7-H3–expressing tumor cells, with expansion cohorts planned in ES-SCLC, HR+/HER2− breast cancer, mCRPC, and ovarian cancer.

ClinicalTrials.gov ID: NCT07424547

No known activity More information High burden on patient More information
Sponsor: Radiopharm Theranostics, Ltd (industry) Phase: 1/2 Start date: Sept. 24, 2025

TrialFetch AI summary: Enrolls adults with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors (including CRPC, NSCLC/SCLC, CRC, HNSCC, ovarian/cervical/endometrial cancers, TNBC, and esophageal SCC) who have progressed after their most recent therapy and have no suitable standard option, with ECOG 0–2 and adequate organ function (measurable disease required except in CRPC; prior Lu-177–PSMA excluded for CRPC). Patients receive 177Lu-BetaBart, a lutetium-177–labeled anti–B7-H3 (CD276) monoclonal antibody delivering beta-particle radiation as systemic radioimmunotherapy in a dose-escalation/expansion design.

ClinicalTrials.gov ID: NCT07189871

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