A Study of CS1002 in Subjects With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT03523819
• Recruitment Status: Completed
• First Posted: May 14, 2018
• Last Update Posted: December 16, 2022
• Sponsor: CStone Pharmaceuticals
• Information provided by (Responsible Party): CStone Pharmaceuticals

Tracking Information

• First Submitted Date: April 22, 2018
• First Posted Date: May 14, 2018
• Last Update Posted Date: December 16, 2022
• Actual Study Start Date: April 26, 2018
• Actual Primary Completion Date: January 18, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 2, 2018): Number of participants with adverse events [ Time Frame: From the day of first dose to 30 days after last dose of CS1002 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of CS1002 in Subjects With Advanced Solid Tumors
• Official Title: A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
• Brief Summary: This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description:

Randomized for Part 3 of the study

Primary Purpose: Treatment

• Condition: Solid Tumor, Adult

Intervention

• Drug: CS1002
  Dose levels will be escalated following a modified 3+3 dose escalation scheme
  Other Name: anti-CTLA 4
• Drug: CS1003
  Fixed dose at 200mg in combination with CS1002 on a specified dose level
  Other Name: anti-PD1

Study Arms

• Experimental: CS1002
  Participants will receive CS1002 intravenously at specified dose on specified days.
  Interventions:

  • Drug: CS1002
  • Drug: CS1003
• Experimental: CS1003
  Participants will receive CS1003 intravenously at fixed dose on specified days.
  Interventions:

  • Drug: CS1002
  • Drug: CS1003

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2022): 91
• Original Estimated Enrollment (submitted: May 2, 2018): 18
• Actual Study Completion Date: January 18, 2022
• Actual Primary Completion Date: January 18, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
2. ECOG performance status of 0 or 1.
3. Life expectancy ≥12 weeks.
4. Subjects must have adequate organ function
5. Use of effective contraception

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Subjects with active autoimmune diseases or history of autoimmune diseases.
3. Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
4. Has received prior therapy with an anti-CTLA-4 agent.
5. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy.
6. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS1002.
7. Receipt of live vaccine within 28 days prior to the first dose of CS1002
8. Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.
9. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
10. Known history of HIV.
11. Subjects with active Hepatitis B or C infection
12. Subjects with active tuberculosis infection.
13. Subjects with an active infection requiring systemic therapy.
14. History of organ transplantation.
15. History of alcoholism or drugs abuse.
16. History of severe hypersensitivity reactions to other mAbs.
17. Subjects with major cardiovascular diseases.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Hong Kong

Administrative Information

• NCT Number: NCT03523819
• Other Study ID Numbers: CS1002-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CStone Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: CStone Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Wanmei Wang; CStone Pharmaceuticals

• PRS Account: CStone Pharmaceuticals
• Verification Date: December 2022