A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

Официальное название

A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

Обзор

This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.

Вмешательства

• Препарат BMS-986490
  Specified dose on specified days.
• Препарат Bevacizumab
  Specified dose on specified days.

Первичные конечные точки

• Number of participnats with Adverse Events (AEs) [Срок оценки: Up to 100 days following discontinuation of dosing]
• Number of participants with Serious AEs (SAEs) [Срок оценки: Up to 100 days following discontinuation of dosing]
• Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [Срок оценки: Up to 28 days after the first treatment of study intervention]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to 100 days following discontinuation of dosing]
• Number of deaths [Срок оценки: Up to 100 days following discontinuation of dosing]

Вторичные конечные точки (6)

• Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [Срок оценки: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)]
• Trough observed concentration (Ctrough) [Срок оценки: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)]
• Maximum observed concentration (Cmax) [Срок оценки: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)]
• Time of maximum observed concentration (Tmax) [Срок оценки: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)]
• Total anti-drug antibodies (ADAs) [Срок оценки: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)]
• Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator [Срок оценки: Up to approximately 4 years]

Критерии участия

Критерии включения

• Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
• CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:

i) Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).

• NSCLC: Part 2A-NSCLC/GC, 2L+ NSCLC:

i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.

ii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.

\- GC: Part 2A-NSCLC/GC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).

ii) ECOG performance status of 0 or 1.

Критерии исключения

• History of anaphylactic reactions to irinotecan and/or bevacizumab.
• Previously received therapy targeting CEACAM5.
• Grade ≥3 ILD/pneumonitis.
• Other protocol-defined Inclusion/Exclusion criteria apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Local Institution - 0007 — Los Angeles
• Local Institution - 0017 — Grand Rapids
• Local Institution - 0004 — Hackensack
• Local Institution - 0006 — Pittsburgh

Австралия · 1 центр

• Tasman Oncology Research — Southport

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT06730750 · CA238-0001 · 2024-518421-14 · U1111-1313-7004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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