A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

Phase 1

Completed

• Conditions: Solid Tumor; Lymphoma
• Interventions: Drug: CS1003 monoclonal antibody

• Registration Number: NCT03809767
• Lead Sponsor: CStone Pharmaceuticals

Brief Summary

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1003 in subjects with advanced solid tumors or lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-29
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Primary Completion: 2021-08-30
• Study Completion: 2022-06-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. Willing to sign the informed consent.
2. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
3. ECOG performance status of 0 or 1.
4. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
5. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
6. Life expectancy ≥ 3 months.
7. Subject must have adequate organ function.
8. Use of effective contraception (males and females).

Exclusion Criteria

1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
2. Subjects with active autoimmune diseases or history of autoimmune diseases.
3. Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
6. History of HIV infection.
7. Subjects with active Hepatitis B and C infection requiring therapy.
8. Subjects with active infection of tuberculosis.
9. History of organ transplantation.
10. Unresolved toxicities from prior anti-cancer therapy.
11. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
12. Subjects with major cardiovascular diseases.
13. History of alcoholism or drugs abuse.
14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS1003 monoclonal antibody	CS1003 monoclonal antibody	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	from the day of first dose to 90 days after last dose of CS1003

Trial Locations

Locations (17)

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

The First Hospital of Jilin University; 🇨🇳 Changchun, China

Hunan Cancer Hospital; 🇨🇳 Changsha, China

West China Hospital Sichuan University; 🇨🇳 Chengdu, China

Huashan Hospital Fudan University; 🇨🇳 Shanghai, China

Shanghai East Hospital; 🇨🇳 Shanghai, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Yunnan Cancer Hospital; 🇨🇳 Kunming, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

Shanghai pulmonary hospital; 🇨🇳 Shanghai, China

Zhongshan Hospital; 🇨🇳 Shanghai, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China