Идёт набор NCT07228247

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors

Фаза I / Фаза II С лечением Solid Tumors, Adult

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: HMPL-A251, HMPL-A251.
Кому может быть актуально: Состояния в реестре: Solid Tumors, Adult. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase Ⅰ/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A251 in Participants With Advanced or Metastatic HER2-Expressing Solid Tumors

Обзор

This is a first-in-human (FIH), phase Ⅰ/Ⅱa, open-label, multicenter clinical study of HMPL-A251 monotherapy in adult participants with unresectable, advanced or metastatic HER2-expressing solid tumors.

Подробное описание

* To evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of HMPL-A251 in participants with previously treated HER2+ solid tumors * To characterize the safety and preliminary efficacy of HMPL-A251 at RDEs to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected HER2-expressing solid tumors

Вмешательства

Препарат HMPL-A251
Six dose cohorts are planned for the Dose Escalation phase; at least three participants with solid tumors will be enrolled in each dose cohort. Bayesian optimal interval design with backfill (BF-BOIN, Zhao, 2023) will be used to guide dose escalation and determine the MTD and/or RDE of HMPL-A251. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.
Препарат HMPL-A251
Participants will be randomized in a 1:1 ratio to receive treatment in two RDEs levels (approximately 15 participants per dose level) for each cohort. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.

Первичные конечные точки

Maximum Tolerated Dose (MTD) [Срок оценки: Approximately 12 months]
Recommended doses for expansion (RDE) [Срок оценки: Approximately 12 months]
Overview of Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Approximately 24 months]
Objective Response Rate (ORR) [Срок оценки: At least 6 weeks post dose of first participant up to approximately 24 months]
Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A251 [Срок оценки: Approximately 12 months]

Вторичные конечные точки (9)

Disease control rate (DCR) [Срок оценки: Approximately 2 years]
Duration of response (DoR) [Срок оценки: Approximately 2 years]
Time to response (TTR) [Срок оценки: Approximately 2 years]
Progression-free survival (PFS) [Срок оценки: Approximately 2 years]
Overall survival (OS) [Срок оценки: Approximately 2 years]
Pharmacokinetic Analysis(Cmax) [Срок оценки: Each cycle(21-day cycle), From C9, every 4 cycles, Approximately 12 months]
Pharmacokinetic Analysis(Tmax) [Срок оценки: Each cycle(21-day cycle), From C9, every 4 cycles, Approximately 12 months]
Pharmacokinetic Analysis((AUC) [Срок оценки: Each cycle(21-day cycle), From C9, every 4 cycles, Approximately 12 months]
To evaluate the immunogenicity of HMPL-A251 [Срок оценки: Each cycle(21-day cycle), From C9, every 4 cycles, Approximately 12 months]

Критерии участия

Критерии включения

Histologically confirmed unresectable advanced or metastatic disease.
Have at least one measurable lesion per RECIST v1.1;
Life expectancy ≥ 12 weeks;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
Weight ≥ 35 kg;

Критерии исключения

An established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus.
Use of strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug;
Toxicity from prior anti-tumor therapy has not recovered to Grade 1 or baseline prior to the first dose of study drug (except alopecia). Participants with chronic Grade 2 toxicities may be eligible after discussion between the investigator and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy-induced neuropathy);
Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant;
Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
Major surgery within 28 days prior to the first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study drug(s);

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

Здоровые добровольцы: Нет