NCT03523819

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2018

Typical duration for phase_1

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

April 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

September 19, 2024

Status Verified

December 1, 2022

Enrollment Period

3.7 years

First QC Date

April 22, 2018

Last Update Submit

September 4, 2024

Conditions

Solid Tumor, Adult

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    From the day of first dose to 30 days after last dose of CS1002

Study Arms (2)

CS1002

EXPERIMENTAL

Participants will receive CS1002 intravenously at specified dose on specified days.

Drug: CS1002Drug: CS1003

CS1003

EXPERIMENTAL

Participants will receive CS1003 intravenously at fixed dose on specified days.

Drug: CS1002Drug: CS1003

Interventions

CS1002DRUG

Dose levels will be escalated following a modified 3+3 dose escalation scheme

Also known as: anti-CTLA 4
CS1002CS1003
CS1003DRUG

Fixed dose at 200mg in combination with CS1002 on a specified dose level

Also known as: anti-PD1
CS1002CS1003

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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.
  • Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
  • Has received prior therapy with an anti-CTLA-4 agent.
  • 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.
  • 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.
  • Receipt of live vaccine within 28 days prior to the first dose of CS1002
  • Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.
  • History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
  • Known history of HIV.
  • Subjects with active Hepatitis B or C infection
  • Subjects with active tuberculosis infection.
  • Subjects with an active infection requiring systemic therapy.
  • History of organ transplantation.
  • History of alcoholism or drugs abuse.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Border Medical Oncology Research Unit

Albury, New South Wales, 2640, Australia

Location

Orange Health Service

Orange, New South Wales, 2800, Australia

Location

St Vincent's hospital

Sydney, New South Wales, 2010, Australia

Location

Southern Medical Day Care Centre

Wollongong, New South Wales, 2500, Australia

Location

Ashford Cancer Centre Research

Adelaide, South Australia, 5037, Australia

Location

Cabrini Health

Malvern, Victoria, 3186, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Boxhill Hospital

Melbourne, Victoria, 3128, Australia

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

IpilimumabCS-1003spartalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Wanmei Wang

    CStone Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomized for Part 3 of the study
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2018

First Posted

May 14, 2018

Study Start

April 26, 2018

Primary Completion

January 18, 2022

Study Completion

January 18, 2022

Last Updated

September 19, 2024

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(8)HK(2)