A Study of CS1003 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of CS1001 in Subjects with Advanced Solid Tumors

NCT03744403

Advanced Solid Tumors

COMPLETED PHASE1

A Study of CS1002 in Subjects with Advanced Solid Tumors

NCT03523819

Solid Tumor, Adult

COMPLETED PHASE1

A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

NCT03809767

Solid Tumor Lymphoma

COMPLETED PHASE1

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

NCT04200404

Advanced Refractory Solid Tumors

COMPLETED PHASE1/PHASE2

A Study of CS3006 in Subjects with Locally Advanced or Metastatic Solid Tumors

NCT03516123

Solid Tumor, Adult

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CS1003

Group Type EXPERIMENTAL

CS1003

Intervention Type BIOLOGICAL

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.

CS1003 + regorafenib

Group Type EXPERIMENTAL

CS1003

Intervention Type BIOLOGICAL

CS1003 to be intravenously administered at the dose level determined during the dose escalation part

Regorafenib

Intervention Type DRUG

Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CS1003

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.

Intervention Type BIOLOGICAL

CS1003

CS1003 to be intravenously administered at the dose level determined during the dose escalation part

Intervention Type BIOLOGICAL

Regorafenib

Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
2. ECOG performance status of 0 or 1.
3. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
4. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
5. Life expectancy ≥ 3 months.
6. Subject must have adequate organ function.
7. Use of effective contraception (males and females).

Exclusion Criteria

1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
2. Subjects with active autoimmune diseases or history of autoimmune diseases.
3. Subjects who have to receive glucocorticoids (prednisone at \> 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib, except for those with basal cell carcinoma, in situ breast cancer and cervical carcinoma in situ who have undergone radical treatment.
5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
6. Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment within 2 weeks prior to the first dose of CS1003.
7. Receipt of major surgical procedure or wide field of radiation within 28 days prior to the first dose of CS1003, local radiotherapy within 14 days prior to the first dose of CS1003, or radioactive agents within 56 days before the first dose of CS1003.
8. Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to the first dose of CS1003.
9. Receipt of live vaccine within 28 days prior to the first dose of CS1003.
10. History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
11. History of HIV infection.
12. Subjects with active Hepatitis B and C infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring therapy.
13. Subjects with active infection of tuberculosis.
14. Subjects with signs or symptoms of any active infection requiring systemic therapy.
15. History of organ transplantation.
16. Unresolved toxicities from prior anti-cancer therapy.
17. History of any irAE of Grade ≥ 3.
18. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
19. History of alcoholism or drugs abuse.
20. Subjects with major cardiovascular diseases.
21. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.

For more information regarding trial participation, please contact at [email protected]

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No