Clinical trial NCT05528055: A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Non Hodgkin Lymphoma
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: Dose limiting toxicity(DLT)
timeFrame: Up to 28 days
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 1 years
Secondary outcomes:
measure: Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions
timeFrame: Up to approximately 1 years
measure: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters.
timeFrame: Up to approximately 1 years
measure: Pharmacokinetic Parameters: Area Under the Curve (AUC)
timeFrame: Up to approximately 1 years
measure: Pharmacokinetic Parameters: Maximum Concentration (Cmax)
timeFrame: Up to approximately 1 years
measure: Pharmacokinetic Parameters: Trough Concentration (Ctrough)
timeFrame: Up to approximately 1 years
measure: Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax)
timeFrame: Up to approximately 1 years
measure: Pharmacokinetic Parameters: Terminal elimination half life (t1/2)
timeFrame: Up to approximately 1 years
measure: Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure
timeFrame: Up to approximately 1 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
Study officials:
References: