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

Sponsor
CStone Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04421352
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
45.6
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 12, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: low-dose radiation+CS1001

low-dose radiation+CS1001

Drug: CS1001
low-dose radiation+CS1001 1200mg Q3W. In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. Dose A: 3Gy/1f; Dose B: 9Gy/3f; Dose C: 15Gy/5f; In the dose expansion part, more SCLC patients will be assigned.

Outcome Measures

Primary Outcome Measures

  1. To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001 [From first dose to 30 days after last dose of CS1001, up to 2 years]

Secondary Outcome Measures

  1. Objective Response Rate as Determined by the Investigator Using RECIST v1.1 [From first dose to 30 days after last dose of CS1001, up to 2 years]

  2. Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [From first dose to 30 days after last dose of CS1001, up to 2 years]

  3. Overall Survival (OS) [From first dose to 30 days after last dose of CS1001, up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital, Sichuan University Chendu Sichuan China 610041

Sponsors and Collaborators

  • CStone Pharmaceuticals

Investigators

  • Principal Investigator: You Lu, MD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CStone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04421352
Other Study ID Numbers:
  • CS1001-101-13
First Posted:
Jun 9, 2020
Last Update Posted:
Jul 7, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Small Cell Lung Carcinoma

Study Results

No Results Posted as of Jul 7, 2022