Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors

Официальное название

ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors

Обзор

This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.

Подробное описание

The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics, and preliminary evaluation of anti-tumor activity.

Вмешательства

• Препарат ACR-2316
  ACR-2316 is an experimental drug

Первичные конечные точки

• Dose Escalation [Срок оценки: Number of DLT events during the DLT observation period (up to 28 days)]
• Dose Expansion [Срок оценки: RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.]
• Dose Expansion [Срок оценки: Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.]
• Dose Expansion [Срок оценки: Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.]

Вторичные конечные точки (12)

• Dose Escalation [Срок оценки: This will be evaluated through study completion, an average of 1 year.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Escalation [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Expansion [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]
• Dose Expansion [Срок оценки: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.]

Критерии участия

Критерии включения

• Signed written informed consent.
• Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
• Must be willing to provide redacted pathology report.
• Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
• Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
• Adequate organ functions.
• Must have progressed after prior line of treatment.

Exclusion Criteria (all participants):

• Participants with known symptomatic brain metastases.
• Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
• Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
• Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
• Women who are 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

США · 15 центров

• HonorHealth Research Institute — Phoenix
• Precision NextGen Oncology & Research Center — Beverly Hills
• Hoag Memorial Hospital Presbyterian — Newport Beach
• Denver Health One — Denver
• Florida Cancer Specialist — Sarasota
• Beth Israel Deaconess Medical Center — Boston
• University of Michigan — Ann Arbor
• Roswell Park Comprehensive Cancer Center — Buffalo
• … и ещё 7 центров

Идентификаторы

NCT: NCT06667141 · ACR-2316-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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