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NCT Number: NCT05528055

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

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCR-6920 capsule

Drug

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

Other names: PRMT5 inhibitor

Primary outcomes

  1. Dose limiting toxicity(DLT)

    Time frame: 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).

  2. Overall Response Rate (ORR)

    Time frame: Up to approximately 1 years

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

Secondary outcomes

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

    Time frame: Up to approximately 1 years

    All AEs, SAEs and dose modifications will be collected. Adverse events as characterized by type, severity, timing and relationship to study therapy. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  2. Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters.

    Time frame: Up to approximately 1 years

    Blood and urine samples will be collected for analysis of lab parameters. Vital signs, electrocardiogram (ECG), physical examinations and organ-specific parameters will be collected at specified time points. Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters will be reported.

  3. Pharmacokinetic Parameters: Area Under the Curve (AUC)

    Time frame: Up to approximately 1 years

    Blood samples will be collected at given time points to determine the AUC (0-t) and AUC (0-inf) of SCR-6920

  4. Pharmacokinetic Parameters: Maximum Concentration (Cmax)

    Time frame: Up to approximately 1 years

    Blood samples will be collected at given time points to determine the Cmax of SCR-6920.

  5. Pharmacokinetic Parameters: Trough Concentration (Ctrough)

    Time frame: Up to approximately 1 years

    Blood samples will be collected at given time points to determine the Ctrough of SCR-6920.

  6. Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax)

    Time frame: Up to approximately 1 years

    Blood samples will be collected at given time points to determine the Tmax of SCR-6920.

  7. Pharmacokinetic Parameters: Terminal elimination half life (t1/2)

    Time frame: Up to approximately 1 years

    Blood samples will be collected at given time points to determine the t1/2 of SCR-6920.

  8. Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure

    Time frame: Up to approximately 1 years

    Evaluation of change from baseline in SDMA, a PD biomarker of PRMT5 inhibition.

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 6, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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