A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

NCT03312842 | Completed Phase 1

• 1 other identifier: CS1001-101
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 2

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 CS1001 in subjects with advanced solid tumors.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of CS1001

  From first dose to 30 days after last dose of CS1001, up to 2 years

• 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

Study Arms (1)

CS1001

EXPERIMENTAL

Drug: CS1001

Interventions

CS1001 DRUG

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.

CS1001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
• ECOG performance status of 0 or 1.
• Subjects must have at least one measurable lesion.
• Patients with life expectancy ≥ 3 months.
• Subject must have adequate organ function.
• Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for six months after last study drug administration.

You may not qualify if:

• Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
• Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
• Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
• Known history of HIV infection.
• Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
• Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
• Known history of alcoholism or drugs abuse.
• For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• Gong J, Cao J, Zhang Q, Xu N, Zhao Y, Xing B, Miao Z, Wu Y, Pan H, Gao Q, Li X, Liu B, Li W, Pei Z, Xia H, Qi Q, Dai H, Shi Q, Yang J, Li J, Shen L. Safety, antitumor activity and biomarkers of sugemalimab in Chinese patients with advanced solid tumors or lymphomas: results from the first-in-human phase 1 trial. Cancer Immunol Immunother. 2022 Aug;71(8):1897-1908. doi: 10.1007/s00262-021-03102-3. Epub 2022 Jan 5.

  PMID: 34984540 DERIVED

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: October 19, 2017
• Primary Completion: August 16, 2021
• Study Completion: February 16, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-02

Locations

CN (2)