A Study of PHN-012 in Patients With Advanced Solid Tumors

Официальное название

First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

Обзор

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Вмешательства

• Препарат PHN-012
  PHN-012 is an ADC

Первичные конечные точки

• Incidence of dose limiting toxicities (Phase 1a) [Срок оценки: 12 months]
• Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) [Срок оценки: 12 months]
• Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) [Срок оценки: 24 months]
• Overall response rate (ORR) (Phase 1b) [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Best overall response (BOR) (Phase 1a and 1b) [Срок оценки: 24 months]
• Disease control rate (DCR) (Phase 1a and 1b) [Срок оценки: 24 months]
• Progression free survival (PFS) (Phase 1a and 1b) [Срок оценки: 24 months]
• Time to response (TTR) (Phase 1a and 1b) [Срок оценки: 24 months]
• Overall survival (OS) (Phase 1a and 1b) [Срок оценки: 24 months]
• Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b) [Срок оценки: 24 months]
• Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b) [Срок оценки: 24 months]
• Pharmacokinetics, Cmax of free payload (Phase 1a and 1b) [Срок оценки: 24 months]
• Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b) [Срок оценки: 24 months]
• Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b) [Срок оценки: 24 months]
• Pharmacokinetics, Tmax of free payload (Phase 1a and 1b) [Срок оценки: 24 months]
• Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b) [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Has histologically confirmed, advanced/metastatic:

• Colorectal adenocarcinoma (CRC), or
• Non-small cell lung cancer (NSCLC), or
• Pancreatic ductal adenocarcinoma (PDAC).
• Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.
• Has measurable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has adequate organ function.
• Has available tumor tissue sample at screening (either an archival specimen or fresh biopsy material).

Критерии исключения

• Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.
• Has unstable central nervous system metastasis.
• Has persistent toxicities from previous systemic anti-cancer treatments of Grade >1.
• Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.
• Has received wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
• Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
• Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids within 6 months prior to first dose of the study drug, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 11 центров

• PHN-012-001 Site — Los Angeles
• PHN-012-001 Site — San Diego
• PHN-012-001 Site — Washington D.C.
• PHN-012-001 Site — Boston
• PHN-012-001 Site — St Louis
• PHN-012-001 Site — Durham
• PHN-012-001 Site — Portland
• PHN-012-001 Site — Nashville
• … и ещё 3 центра

Испания · 9 центров

• PHN-012-001 Site — Barcelona
• PHN-012-001 Site — Barcelona
• PHN-012-001 Site — Madrid
• PHN-012-001 Site — Madrid
• PHN-012-001 Site — Madrid
• PHN-012-001 Site — Madrid
• PHN-012-001 Site — Madrid
• PHN-012-001 Site — Valencia
• … и ещё 1 центр

South Korea · 6 центров

• PHN-012-001 Site — Seoul
• PHN-012-001 Site — Seongnam-si
• PHN-012-001 Site — Seoul
• PHN-012-001 Site — Seoul
• PHN-012-001 Site — Seoul
• PHN-012-001 Site — Seoul

Идентификаторы

NCT: NCT07127874 · PHN-012-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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