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PEER-TO-PEER CLINICAL CONVERSATIONS
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Phase 1 Study Evaluates Bone Metastasis Resolution with SYNC-T Therapy SV-102
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Gerald Andriole, MD
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| Zachary Klaassen hosts Gerald Andriole to discuss phase 1 findings with SYNC-T therapy SV-102 in metastatic prostate cancer. The investigational approach combines brief tumor cryolysis with immediate intratumoral administration of a four-component immunoadjuvant designed to stimulate tumor-specific T-cell responses.
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ABBV-969 Dual-Targeted ADC in Heavily Pretreated mCRPC
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Tanya Dorff, MD
Tanya Dorff presents phase 1 data on ABBV-969, a dual-targeting antibody-drug conjugate binding PSMA and STEAP1 to deliver a topoisomerase payload in 49 heavily pretreated mCRPC patients, over 80% of whom had received docetaxel and more than half had prior lutetium.
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ProTACT Trial Investigates Next-Generation PSMA-Targeted Alpha Therapy for mCRPC
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Aaron Hansen, MBBS, FRACP
Aaron Hansen reports phase one data on Actinium-225 FL-020, a PSMA-targeted alpha-emitting radioligand therapy, in metastatic castration-resistant prostate cancer.
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| Phase 2 Study of YL201, an Anti-B7H3 Antibody-Drug Conjugate, in Heavily Pretreated mCRPC
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| Yao Zhu, MD
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| Yao Zhu discusses the phase 2 YL201-CN-201-01 trial of 82 heavily pretreated mCRPC patients.The B7-H3–targeting ADC tambotatug pelitecan (tam‑peli, YL201) showed encouraging activity: confirmed ORR 32.8% overall (38.9% at 2.4 mg/kg), confirmed PSA50 37.2%, median rPFS 9.9 months, and 15‑month OS 57.8%, with maintained responses in visceral and liver metastases.
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| TIDAL: A Phase II Study of the DLL3-Directed T-Cell Engager Tarlatamab in DLL3-Positive Metastatic Prostate Cancer
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| Karen Autio, MD, MSc
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| TIDAL is a multicenter, single-arm phase II trial evaluating the DLL3-targeted bispecific T-cell engager tarlatamab in patients with DLL3-positive metastatic prostate cancer who have progressed after at least one prior systemic therapy; dosing uses a step-up schedule with mandatory short inpatient monitoring due to cytokine-release risk.
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| Phase I/II Study to Evaluate AZD9750, a Novel Androgen Receptor Proteolysis-Targeting Chimera, Alone and in Combination with Other Anticancer Agents in Patients with Metastatic Prostate Cancer (ANDROMEDA)
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| Neeraj Agarwal, MD, FASCO
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| The ANDROMEDA trial is a first-in-human, modular phase I/II, open-label study evaluating AZD9750, an oral androgen receptor PROTAC, as monotherapy and in combination with the PARP1 inhibitor saruparib in patients with metastatic castration-resistant prostate cancer who have progressed after prior ARPI (and usually prior taxane). Primary objectives focus on safety, tolerability, dose-limiting toxicities, and preliminary antitumor activity
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| HRS-1167 (M9466), a PARP1 Inhibitor, Combined with Abiraterone Acetate and Prednisone in mCRPC: A Phase 1b/2 Study
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| Chaochao Liang
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| This phase 1b/2 study of the selective PARP1 inhibitor HRS-1167 plus abiraterone/prednisone in 58 Chinese men with HRR-mutated mCRPC showed encouraging preliminary activity, with PSA50 responses in 36.4% and 52%, disease control rates of 81.8% and 92.0%, and particularly high PSA50 rates in BRCA-mutated patients. Safety was manageable with predominantly hematologic grade ≥3 toxicities, no new safety signals, and no treatment-related deaths, supporting further evaluation of selective PARP1 inhibition combined with AR pathway blockade, especially in BRCA-mutated mCRPC.
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| AcTION: Phase 1 Study of 225Ac-PSMA-617 in Men with mCRPC with or Without Prior 177Lu-PSMA Radioligand Therapy
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| Louise Emmett, MD, MBChB, FRACP, FAANMS
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| Louise Emmett discusses AcTION, the first prospective phase 1 dose-escalation study of the alpha-emitting radioligand 225Ac-PSMA-617 in PSMA-positive mCRPC, enrolling 101 patients across three groups: post-chemo/ARPI and 177Lu-naïve, chemo/ARPI-naïve, and prior 177Lu-PSMA, with doses of 4–10 MBq q8w for up to 6 cycles.
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