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

NCT05528055 | Recruiting Phase 1

• 1 other identifier: SIM1907-04-PRMT5-101
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Solid Tumor; Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity(DLT)

  DLT will be evaluated within 28 days since first dose. The number of DLTs will be used to determine the maximum tolerated dose (MTD).

  Up to 28 days

• Overall Response Rate (ORR)

  Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria

  Up to approximately 1 years

Secondary Outcomes (8)

• Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions

  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.

  Up to approximately 1 years

• Pharmacokinetic Parameters: Area Under the Curve (AUC)

  Up to approximately 1 years

• Pharmacokinetic Parameters: Maximum Concentration (Cmax)

  Up to approximately 1 years

• Pharmacokinetic Parameters: Trough Concentration (Ctrough)

  Up to approximately 1 years

Study Arms (4)

Dose escalation

EXPERIMENTAL

Participants will receive SCR-6920 capsule orally at escalating doses, till the maximum tolerated dose level is reached, and the recommended phase 2 dose(RP2D) will be determined.

Drug: SCR-6920 capsule

Dose expansion: non small cell lung cancer(NSCLC)

EXPERIMENTAL

Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose

Drug: SCR-6920 capsule

Dose expansion: NHL

EXPERIMENTAL

Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis

Drug: SCR-6920 capsule

Dose expansion: solid tumors

EXPERIMENTAL

Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis

Drug: SCR-6920 capsule

Interventions

SCR-6920 capsule DRUG

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

Also known as: PRMT5 inhibitor

Dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: September 6, 2022
• Study Start: May 18, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

CN (1)