A Study of CS1002 in Subjects with Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2022-01-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Randomized for Part 3 of the study

Study Groups

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CS1002

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

Group Type EXPERIMENTAL

CS1002

Intervention Type DRUG

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

CS1003

Intervention Type DRUG

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

CS1003

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

Group Type EXPERIMENTAL

CS1002

Intervention Type DRUG

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

CS1003

Intervention Type DRUG

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

Interventions

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CS1002

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

Intervention Type DRUG

CS1003

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

Intervention Type DRUG

Other Intervention Names

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anti-CTLA 4 anti-PD1

Eligibility Criteria

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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 [email protected]

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No