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

September 2, 2022 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose escalation
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
SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
Other Names:
  • PRMT5 inhibitor
Drug: SCR-6920 capsule
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
Other Names:
  • PRMT5 inhibitor
Experimental: Dose expansion: non small cell lung cancer(NSCLC)
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose
Drug: SCR-6920 capsule
SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
Other Names:
  • PRMT5 inhibitor
Drug: SCR-6920 capsule
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
Other Names:
  • PRMT5 inhibitor
Experimental: Dose expansion: NHL
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
Drug: SCR-6920 capsule
SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
Other Names:
  • PRMT5 inhibitor
Drug: SCR-6920 capsule
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
Other Names:
  • PRMT5 inhibitor
Experimental: Dose expansion: solid tumors
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
Drug: SCR-6920 capsule
SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
Other Names:
  • PRMT5 inhibitor
Drug: SCR-6920 capsule
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
Other Names:
  • PRMT5 inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 28 days
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
Up to approximately 1 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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.
Up to approximately 1 years
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
Up to approximately 1 years
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.
Up to approximately 1 years
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.
Up to approximately 1 years
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.
Up to approximately 1 years
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.
Up to approximately 1 years
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.
Up to approximately 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Simcere Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIM1907-04-PRMT5-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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