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CompletedNCT03523819Updated Sep 19, 2024

A Study of CS1002 in Subjects with Advanced Solid Tumors

A Phase 1 interventional study of CS1002 and CS1003 in Solid Tumor, Adult, sponsored by CStone Pharmaceuticals. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by CStone Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumor, Adult

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Keywords

  • Solid Tumors
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 91 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

CStone Pharmaceuticals is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    CS1002

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

    Drug: CS1002 · Drug: CS1003

  • Experimental
    CS1003

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

    Drug: CS1002 · Drug: CS1003

Interventions

  • DrugCS1002

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

    Also known as: anti-CTLA 4

  • DrugCS1003

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

    Also known as: anti-PD1

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

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

07

Study locations

10 sites
  • Border Medical Oncology Research Unit
    Albury, New South Wales 2640, Australia
  • Orange Health Service
    Orange, New South Wales 2800, Australia
  • St Vincent's hospital
    Sydney, New South Wales 2010, Australia
  • Southern Medical Day Care Centre
    Wollongong, New South Wales 2500, Australia
  • Ashford Cancer Centre Research
    Adelaide, South Australia 5037, Australia
  • Cabrini Health
    Malvern, Victoria 3186, Australia
  • Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Boxhill Hospital
    Melbourne, Victoria 3128, Australia
  • Prince of Wales Hospital
    Hong Kong, Hong Kong
  • Queen Mary Hospital
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03523819
Lead sponsor
CStone Pharmaceuticals
Responsible party
Sponsor
First posted
May 14, 2018
Start date
Apr 26, 2018
Primary completion
Jan 18, 2022
Completion
Jan 18, 2022
Last update
Sep 19, 2024

Study contacts

Wanmei Wang
study director · CStone Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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