MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Официальное название

A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Обзор

The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.

Вмешательства

• Препарат LY3962673
  Administered orally.
• Препарат Cetuximab
  Administered intravenously.
• Препарат Gemcitabine
  Administered intravenously.
• Препарат nab-paclitaxel
  Administered intravenously.
• Препарат Oxaliplatin
  Administered intravenously.
• Препарат leucovorin
  Administered intravenously.
• Препарат Irinotecan
  Administered intravenously.
• Препарат 5-fluorouracil
  Administered intravenously.

Первичные конечные точки

• Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Срок оценки: Baseline through 5 years]
• Phase 1a: Number of Participants with DLT [Срок оценки: During the first 28-day cycle of LY3962673 treatment]
• Phase 1a: Number of Participants with DLT Equivalent Toxicities [Срок оценки: During the first 28-day cycle of LY3962673 treatment]
• Phase 1b: Overall Response Rate (ORR) [Срок оценки: Up to approximately 5 years]
• Phase 1b: Best Overall Response (BOR) [Срок оценки: Up to approximately 5 years]
• Phase 1b: Duration of Response (DOR) [Срок оценки: Up to approximately 5 years]
• Phase 1b: Time to Response (TTR) [Срок оценки: Up to approximately 5 years]
• Phase 1b: Disease Control Rate (DCR) [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (8)

• Phase 1a: Overall Response Rate (ORR) [Срок оценки: Up to approximately 5 years]
• Best Overall Response (BOR) [Срок оценки: Up to approximately 5 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 5 years]
• Time to Response (TTR) [Срок оценки: Up to approximately 5 years]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 5 years]
• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673 [Срок оценки: Predose through Day 168]
• PK: Time to Maximum Concentration (Tmax) of LY3962673 [Срок оценки: Predose through Day 168]
• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673 [Срок оценки: Predose through Day 168]

Критерии участия

Критерии включения

• Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
• Have an ECOG performance status of ≤ 1
• Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease
• Participants with asymptomatic or treated CNS disease may be eligible.

Критерии исключения

• Have known active CNS metastases and/or carcinomatous meningitis.
• Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.
• Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction.
• Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
• Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
• Have other active malignancy unless in remission with life expectancy greater than (>) 2 years.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 25 центров

• City of Hope — Duarte
• University of California, Los Angeles (UCLA) — Santa Monica
• Sarah Cannon Research Institute at HealthOne — Denver
• Sibley Memorial Hospital — Washington D.C.
• Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute — Orlando
• Emory University School of Medicine — Atlanta
• Community Health Network — Indianapolis
• Massachusetts General Hospital — Boston
• … и ещё 17 центров

Япония · 5 центров

• National Cancer Center Hospital East — Chiba
• Kanagawa cancer center — Kanagawa
• Aichi Cancer Center Hospital — Nagoya
• Kansai Medical University Hospital — Osaka
• National Cancer Center Hospital — Tokyo

Китай · 4 центра

• Cancer Institute & Hospital, Chinese Academy of Medical Sciences — Пекин
• Beijing Cancer hospital — Пекин
• Harbin Medical University Cancer Hospita — Харбин
• Fudan University Shanghai Cancer Center — Шанхай

Франция · 4 центра

• Centre Leon Berard — Lyon
• Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone — Marseille
• Oncopole Claudius Regaud — Toulouse
• Institut Gustave Roussy — Villejuif

Германия · 4 центра

• Charite Universitaetsmedizin Berlin — Berlin
• Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
• Universitaetsklinikum Essen — Essen
• Klinikum der Ludwig-Maximilians-Universitaet Muenchen — München

Испания · 4 центра

• South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos — Barcelona
• Hospital Universitario Vall d'Hebron — Barcelona
• South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez — Madrid
• Hospital Universitario 12 de Octubre — Madrid

Италия · 3 центра

• Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli — Naples
• UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica — Roma
• Centro Ricerche Cliniche di Verona s.r.l. — Verona

Канада · 2 центра

• The Ottawa Hospital — Ottawa
• Princess Margaret Hospital — Toronto

Ирландия · 1 центр

• START Dublin Early Phase Clinical Trials Unit — Dublin

Идентификаторы

NCT: NCT06586515 · 27189 · J5J-OX-JZZA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗