Идёт набор NCT06892379

A Study of HS-20110 in Participants With Advanced Solid Tumors

Фаза I С лечением Solid Tumors

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: HS-20110 (Phase Ia：Dose escalation ), HS-20110 (Phase Ib:Dose expansion ).
Кому может быть актуально: Состояния в реестре: Solid Tumors. 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 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 in Participants With Advanced Solid Tumors

Обзор

This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors

Вмешательства

Препарат HS-20110 (Phase Ia：Dose escalation )
HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles
Препарат HS-20110 (Phase Ib:Dose expansion )
The recommended dose from the dose-escalation stage and other potential doses will be further explored

Первичные конечные точки

Maximum tolerated dose (MTD) or maximum applicable dose (MAD) [Срок оценки: From day 1 to one months after the last dose in Phase 1a]
Objective response rate (ORR) as per RECIST v1.1 [Срок оценки: From screening to 2 months after the last dose]

Вторичные конечные точки (4)

Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities [Срок оценки: From the first dose until 90 days after the last dose]
Objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; overall survival (OS) [Срок оценки: From screening to up to 3 years after last dose]
Incidence of anti-HS-20110 antibody (ADA) [Срок оценки: From the first dose until 90 days after the last dose]
Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload) [Срок оценки: From the first dose until 90 days after the last dose]

Критерии участия

Критерии включения

Males or females, aged ≥ 18 years.
Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.

Критерии исключения

Participants have received or are receiving the following treatment:

Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor T cells).
Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.
Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.
Major surgery within 4 weeks prior to the first dose of study treatment.
Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.
Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.
Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.
Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).
Inadequate bone marrow reserve or hepatic and renal functions.
Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
Participants who are allergic to any component of HS-20110.

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

Здоровые добровольцы: Нет