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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Shandong Cancer Hospital
RECRUITING
Jinan
Time Frame
Start Date: 2022-05-18
Estimated Completion Date: 2027-10
Participants
Target number of participants: 122
Treatments
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.
Experimental: Dose expansion: non small cell lung cancer(NSCLC)
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose
Experimental: Dose expansion: NHL
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
Experimental: Dose expansion: solid tumors
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Simcere Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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