Study of HLD-0915 in Patients With Metastatic Prostate Cancer

Официальное название

Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer

Обзор

Assessment of the safety and efficacy of HLD-0915 in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.

Подробное описание

This is a Phase 1/2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of oral single-agent HLD-0915.

The study includes an initial Phase 1 open-label portion to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0915 as monotherapy, followed by Phase 2 expansion cohorts to further evaluate the safety and efficacy of HLD-0915.

Phase 1 is conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior systemic therapies. Phase 1 includes Part 1, an open-label monotherapy dose-escalation using a Bayesian optimal interval with backfill (BF-BOIN) design. Phase 1 also includes Part 2 (open-label), which evaluates the relative bioavailability of HLD-0915 formulations.

Phase 2 will evaluate the safety, PK, and anti-tumor activity of HLD-0915 administered at the RDEs. Phase 2, Part 1 will randomize patients and assess dose strengths in patients with mCRPC to support registrational dose selection. Additional Phase 2 open-label expansion cohorts will further evaluate preliminary safety and efficacy in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Вмешательства

• Препарат HLD-0915 Hard Capsule
  Experimental: Oral HLD-0915
• Препарат HLD-0915 Tablet
  Experimental: Oral HLD-0915
• Препарат HLD-0915 Soft Capsule
  Experimental: Oral HLD-0915

Первичные конечные точки

• Frequency of dose-limiting toxicities (DLTs) [Срок оценки: 21 days]
• Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline [Срок оценки: 21 days]
• Phase 1 Part 2 (formulation exploration) relative bioavailability [Срок оценки: 22 days]

Вторичные конечные точки (6)

• PK Parameters [Срок оценки: 21 days]
• Change in PSA over time [Срок оценки: 21 days]
• Objective Response Rate (ORR) [Срок оценки: 63 days]
• Duration of Response (DOR) [Срок оценки: 21 days]
• Radiographic Progression-Free Survival (rPFS) [Срок оценки: 63 days]
• Time to Response (TTR) [Срок оценки: 63 days]

Критерии участия

Patients must meet the following criteria to be eligible study participation:

Критерии включения

All Study Arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):

Males ≥ 18 years old Histological, pathological, and/or cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication

mCRPC Arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen

SOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng/mL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI

mHSPC arms (Phase 2 Part 2B, 2C \& 2D) serum testosterone >150ng/ml mHSPC with distant metastatic disease based on conventional imaging and PSA >2.0 ng/mL

Критерии исключения

All arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):

Has experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of >10 mg/day Prior or ongoing significant medical condition

mCRPC arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods

SOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer

mHSPC arms (Phase 2 Part 2B, 2C \& 2D) regional pelvic lymph node disease only

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Sarah Cannon Research Institute at HealthONE — Denver
• Yale - New Haven Hospital - Yale Cancer Center — New Haven
• Florida Cancer Specialists — Sarasota
• Massachusetts General Hospital — Boston
• START Midwest, LLC — Grand Rapids
• Memorial Sloan Kettering Cancer Center — New York
• Duke University Medical Center — Durham
• Carolina Urologic Research Center, LLC — Myrtle Beach
• … и ещё 3 центра

Великобритания · 1 центр

• Royal Marsden Hospital — Sutton

Идентификаторы

NCT: NCT06800313 · HLD-0915-ONC-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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