A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

Официальное название

A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors

Обзор

A Phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, PK, and preliminary efficacy of SCR-6920 capsule in participants with advanced malignant tumors. The purpose of the study is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D), and to confirm the tolerability and preliminary efficacy of SCR-6920 in participants with advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma(NHL).

Вмешательства

• Препарат SCR-6920 capsule
  SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
• Препарат SCR-6920 capsule
  SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
• Препарат SCR-6920 capsule
  SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
• Препарат SCR-6920 capsule
  SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis

Первичные конечные точки

• Dose limiting toxicity(DLT) [Срок оценки: Up to 28 days]
• Overall Response Rate (ORR) [Срок оценки: Up to approximately 1 years]

Вторичные конечные точки (8)

• Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions [Срок оценки: Up to approximately 1 years]
• Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters. [Срок оценки: Up to approximately 1 years]
• Pharmacokinetic Parameters: Area Under the Curve (AUC) [Срок оценки: Up to approximately 1 years]
• Pharmacokinetic Parameters: Maximum Concentration (Cmax) [Срок оценки: Up to approximately 1 years]
• Pharmacokinetic Parameters: Trough Concentration (Ctrough) [Срок оценки: Up to approximately 1 years]
• Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax) [Срок оценки: Up to approximately 1 years]
• Pharmacokinetic Parameters: Terminal elimination half life (t1/2) [Срок оценки: Up to approximately 1 years]
• Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure [Срок оценки: Up to approximately 1 years]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed NHL
• Relapsed/refractory solid tumor or relapsed/refractory NHL who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available.
• At least one evaluable or measurable lesion (as defined in the protocol).
• ECOG Performance Status 0 or 1.
• Life expectancy ≥12 weeks.
• Adequate organ function (as defined in the protocol).
• Reproductive criteria (as defined in the protocol).

Критерии исключения

• Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption.
• Major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. Radiation therapy within 2 weeks prior to study entry.
• Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ).
• Autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose.
• History of a second malignancy within 2 years (as defined in the protocol).
• Active uncontrolled or symptomatic lung disease (as defined in the protocol).
• Intracranial hypertension or active uncontrolled or symptomatic CNS metastases.
• Known or suspected hypersensitivity to study medications.
• Known active uncontrolled or symptomatic CNS metastases.
• The investigator determined that the patient should not participate in the study.
• Known mental illness or substance abuse that may disrupt therapy.
• Clinically significant cardiac abnormalities (as defined in the protocol).
• Gestating or Lactating women.
• Pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose.
• The patient is currently using a drug known to be a strong inhibitor or inducer of CYP3A4.

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

Китай · 1 центр

• Shandong Cancer Hospital — Цзинань

Идентификаторы

NCT: NCT05528055 · SIM1907-04-PRMT5-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗