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Recruiting Phase 1

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

NCT05528055 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2022-05-18
Last updated
2022-09-06

Condition(s) studied

Solid TumorNon Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

SCR-6920 capsuleSCR-6920 capsuleSCR-6920 capsuleSCR-6920 capsule

SCR-6920 capsule: SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis

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

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

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

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Dose limiting toxicity(DLT) — Up to 28 days
    DLT will be evaluated within 28 days since first dose. The number of DLTs will be used to determine the maximum tolerated dose (MTD).
  • Overall Response Rate (ORR) — Up to approximately 1 years
    Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria

Trial sites (1)

FacilityCityRegionStatus
Shandong Cancer Hospital Jinan Shandong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05528055 on ClinicalTrials.gov ↗ ← All trials in China