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Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients

A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

NCT04421352•CStone Pharmaceuticals

View on ClinicalTrials.gov

Summary

A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients

Detailed Description

This is a dose-escalation study of Low-dose Radiation in combination with CS1001 in relapsed SCLC patients. Patients are assigned to 3 treatment groups received from 3 Gy to 15Gy, to determine the safety, tolerability and the maximal tolerant dose. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with histologically or cytologically confirmed LS-SCLC or ES-SCLC and experienced progression since first-line standard platinum containing dual-drug chemotherapy.
•2. Patients whose initial diagnosis was limited must undergo radical chest radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or cannot receive radical chest radiotherapy due to specific reasons
•3. At least one extracranial measurable lesion (RECIST v1.1), and for a lesion that has received radiotherapy, progression of the lesion after radiotherapy must be confirmed.
•4. Patients with brain metastases are allowed to receive previous radiotherapy and their condition is stable, but the time to the end of radiotherapy must not be less than 3 months.
•5. No radiotherapy contraindications were judged by the radiologist
•6. ECOG performance status of 0 or 1.
•7. Patients with life expectancy ≥ 3 months.
•8. Patients must have adequate organ function.
•9. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 6 months after last study drug administration.

Exclusion Criteria

•1. Subjects known to have primary CNS tumors or meningeal metastases or unstable CNS metastases.
•2. Patients with active autoimmune diseases or history of autoimmune diseases should be excluded.
•3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
•4. Known history of HIV infection.
•5. Subjects with active chronic hepatitis B or active hepatitis C .
•6. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
•7. Known history of alcoholism or drugs abuse.
•8. Subjects with history of radiation pneumonitis of grade 3 or above, regardless of recovered or not.

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

January 12, 2021

Primary Completion Date

December 22, 2023

Completion Date

December 22, 2023

Last Updated

March 7, 2024

Enrollment

ACTUAL participants

Conditions

Relapsed Small Cell Lung Cancer

Interventions

CS1001

DRUG

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

NCT06681220

Relapsed Small Cell Lung CancerRecurrent Small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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