Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

Официальное название

A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants With Selected Advanced PIWIL1-Positive Cancers

Обзор

This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A\*02:01-positive participants with selected advanced PIWIL1-Positive cancers.

Вмешательства

• Препарат IMC-R117C
  IV infusion
• Препарат Chemotherapy drug
  IV infusion
• Препарат Chemotherapy drug
  oral
• Препарат Kinase inhibitor
  oral
• Препарат Antiangiogenic Agent
  IV infusion
• Препарат Monoclonal antibody
  IV infusion

Первичные конечные точки

• Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) [Срок оценки: Up to ~24 months]
• Dose Escalation: Percentage of participants with ≥1 adverse event (AE) [Срок оценки: Up to ~24 months]
• Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE) [Срок оценки: Up to ~24 months]
• Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings [Срок оценки: Up to ~24 months]
• Dose Escalation: Percentage of participants with significant changes in vital signs [Срок оценки: Up to ~24 months]
• Dose Escalation: Percentage of participants with significant changes in laboratory results [Срок оценки: Up to ~24 months]
• Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation [Срок оценки: Up to ~24 months]
• Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1 [Срок оценки: Up to ~24 months]

Вторичные конечные точки (12)

• Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination [Срок оценки: Up to ~36 months]
• Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination [Срок оценки: Up to ~36 months]
• Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination [Срок оценки: Up to ~36 months]
• Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination [Срок оценки: Up to ~36 months]
• Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy [Срок оценки: Up to ~36 months]
• Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy [Срок оценки: Up to ~36 months]
• Expansion: Overall Survival (OS) with IMC-R117C Monotherapy [Срок оценки: Up to ~36 months]
• Expansion: Percentage of participants with ≥1 Adverse Events (AE) [Срок оценки: Up to ~24 months]
• Expansion: Percentage of participants with ≥1 Serious Adverse Events (SAE) [Срок оценки: Up to ~24 months]
• Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings [Срок оценки: Up to ~24 months]
• Expansion: Percentage of participants with significant changes in vital signs [Срок оценки: Up to ~24 months]
• Expansion: Percentage of participants with significant changes in laboratory findings [Срок оценки: Up to ~24 months]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• HLA-A\*02:01-positive
• Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma
• Archived or fresh tumor tissue sample that must be confirmed as adequate
• Evaluable/Measurable disease per RECIST 1.1
• Previously received applicable standard treatments
• Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control

Критерии исключения

• Symptomatic or untreated central nervous system metastasis
• Recent bowel obstruction
• Ongoing ascites or effusion requiring recent drainages
• Significant ongoing toxicity from prior anticancer treatment
• Out-of-range laboratory values
• Clinically significant lung, heart, or autoimmune disease
• Ongoing requirement for immunosuppressive treatment
• Significant secondary malignancy
• Hypersensitivity to study drug or excipients
• Pregnant or lactating

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

Испания · 4 центра

• Hospital HM Nou Delfos — Barcelona
• VHIO, Vall d'Hebron University Hospital — Barcelona
• Centro Integral Oncologico Clara Campal — Madrid
• Hospital Universitario Fundacion Jimenez Diaz — Madrid

Бельгия · 3 центра

• Institut Jules Bordet — Anderlecht
• Universitair Ziekenhuis Gent — Ghent
• UZ Leuven — Leuven

Австралия · 2 центра

• St Vincent's Hospital — Darlinghurst
• Peter MacCallum Cancer Centre — Melbourne

Италия · 2 центра

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
• nstituto Clinico Humanitas — Rozzano

Германия · 1 центр

• Universitaetsklinikum Heidelberg — Heidelberg

Нидерланды · 1 центр

• Antoni van Leeuwenhoek — Amsterdam

Идентификаторы

NCT: NCT06840119 · IMC-R117C-1004 · 2023-508090-87-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗