Solid TumorPhase 1NCT05528055
A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
A Phase 1 study testing SCR-6920 capsule in people with Solid Tumor and Non Hodgkin Lymphoma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Non Hodgkin Lymphoma
- What is being tested?
- SCR-6920 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2022to Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Jinming Yu, 0531-67626971, sdyujinming@126.com
About this study
Official 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
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
- Being tested
- SCR-6920 capsule
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCR-6920 capsuleDrug
Also called PRMT5 inhibitor
SCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis
SCR-6920 capsuleDrug
Also called PRMT5 inhibitor
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
SCR-6920 capsuleDrug
Also called PRMT5 inhibitor
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
SCR-6920 capsuleDrug
Also called PRMT5 inhibitor
SCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: Drug: SCR-6920 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
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)
Measured: 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.
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.
Measured: Up to approximately 1 years
Pharmacokinetic Parameters: Area Under the Curve (AUC)
Blood samples will be collected at given time points to determine the AUC (0-t) and AUC (0-inf) of SCR-6920
Measured: Up to approximately 1 years
Pharmacokinetic Parameters: Maximum Concentration (Cmax)
Blood samples will be collected at given time points to determine the Cmax of SCR-6920.
Measured: Up to approximately 1 years
Pharmacokinetic Parameters: Trough Concentration (Ctrough)
Blood samples will be collected at given time points to determine the Ctrough of SCR-6920.
Measured: Up to approximately 1 years
Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax)
Blood samples will be collected at given time points to determine the Tmax of SCR-6920.
Measured: Up to approximately 1 years
Pharmacokinetic Parameters: Terminal elimination half life (t1/2)
Blood samples will be collected at given time points to determine the t1/2 of SCR-6920.
Measured: Up to approximately 1 years
Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure
Evaluation of change from baseline in SDMA, a PD biomarker of PRMT5 inhibition.
Measured: Up to approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start18 May 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528055
- Sponsor's protocol ID
- SIM1907-04-PRMT5-101
- Status last verified
- Sep 2022
- First submitted
- 10 May 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05528055
- Acronym / sponsor ID
- SIM1907-04-PRMT5-101
- Conditions
- Solid Tumor, Non Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: SCR-6920 capsuleParticipants 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. |
| Dose expansion: non small cell lung cancer(NSCLC) | Experimental | Drug: SCR-6920 capsuleParticipants will receive SCR-6920 capsule orally at the recommended phase 2 dose |
| Dose expansion: NHL | Experimental | Drug: SCR-6920 capsuleParticipants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis |
| Dose expansion: solid tumors | Experimental | Drug: SCR-6920 capsuleParticipants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCR-6920 capsuleAlso: PRMT5 inhibitorSCR-6920 capsule will be oral administered once daily at escalating doses on a continuous basis | Drug | Dose escalation |
| SCR-6920 capsuleAlso: PRMT5 inhibitorSCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis | Drug | Dose expansion: non small cell lung cancer(NSCLC) |
| SCR-6920 capsuleAlso: PRMT5 inhibitorSCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis | Drug | Dose expansion: NHL |
| SCR-6920 capsuleAlso: PRMT5 inhibitorSCR-6920 capsule will be oral administered once daily at the recommended phase 2 dose on a continuous basis | Drug | Dose expansion: solid tumors |
Primary outcome
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).
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
8 secondary outcomes
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
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
Pharmacokinetic Parameters: Area Under the Curve (AUC)
Time frame: Up to approximately 1 years
Pharmacokinetic Parameters: Maximum Concentration (Cmax)
Time frame: Up to approximately 1 years
Pharmacokinetic Parameters: Trough Concentration (Ctrough)
Time frame: Up to approximately 1 years
Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax)
Time frame: Up to approximately 1 years
Pharmacokinetic Parameters: Terminal elimination half life (t1/2)
Time frame: Up to approximately 1 years
Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure
Time frame: Up to approximately 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCR-6920 capsule in people with Solid Tumor and Non Hodgkin Lymphoma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity(DLT) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.