A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors

Официальное название

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10386 in Participants With Advanced Solid Tumors

Обзор

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.

Подробное описание

This is a phase I open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in subjects with advanced solid tumors.

Вмешательства

• Препарат HS-10386
  Starting dose 10 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of HS-10386, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined

Первичные конечные точки

• Maximum Tolerated Dose (MTD) or Maximum Applicable Dose (MAD) (Dose Escalation Phase) [Срок оценки: Up to 21 days from the first dose]
• Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Expansion Phase) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months.]

Вторичные конечные точки (12)

• Incidence and Severity of Adverse Events (AEs) [Срок оценки: From Informed consent until the end of the follow-up period which is defined as 28 days (+7 days) after study treatment is discontinued.]
• Cmax of HS-10386 [Срок оценки: Approximately 1 month.]
• Tmax of HS-10386 [Срок оценки: Approximately 1 month.]
• λz of HS-10386 [Срок оценки: Approximately 1 month.]
• t1/2 of HS-10386 [Срок оценки: Approximately 1 month.]
• AUC0-t of HS-10386 [Срок оценки: Approximately 1 month]
• CL/F of HS-10386 [Срок оценки: Approximately 1 month.]
• ORR defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Escalation Phase) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months.]
• Disease Control Rate (DCR) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months.]
• Duration of Response (DoR) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months.]
• Progression-Free Survival (PFS) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months.]
• Overall Survival (OS) (Dose Expansion Phase) [Срок оценки: From the time of randomization to death due to any cause, approximately 3 years.]

Критерии участия

Критерии включения

• Male or female, 18-75 years old.
• Histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable.
• At least one measurable lesion per RECIST v1.1.
• Willingness to provide fresh or archival tumor biopsy sample.
• An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
• Willingness to use adequate contraceptive measures throughout the study.
• Ability to comprehend and willingness to sign a written ICF for the study.

Критерии исключения

• Treatment with any of the following:

• Previous or current treatment with systemic immunotherapy.
• Treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of HS-10386.
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
• Known additional malignancy.
• History or risk of autoimmune disease.
• Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation.
• Inadequate bone marrow reserve or organ function.
• Clinically significant cardiac disease.
• Any evidence of severe or uncontrolled systemic diseases
• Severe infections within 4 weeks prior to the first scheduled dose or symptoms of infection within 2 weeks prior to prior to the first scheduled dose.
• History of organ transplantation or any medical condition requiring the use of systemic immunosuppressive medications.
• Active HBV or HCV infection that requires treatment.
• Known history of HIV.
• Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.
• Administration of a live, attenuated vaccine within 4 weeks prior to the first scheduled dose or anticipation that such a live attenuated vaccine will be required during the study.
• History of severe anaphylaxis or allergic to any of the components of HS-10386.
• Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT05911464 · HS-10386-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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