A Study of CS1003 in Subjects With Advanced Solid Tumors

NCT03475251 | Completed Phase 1

• 2 other identifiers: CS1003-101ACTRN12618000382279
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  From the day of first dose to 30 days after last dose of CS1003

Secondary Outcomes (6)

• Area under the plasma concentration-time curve (AUC)

  From the day of first dose to 30 days after last dose of CS1003

• Maximum plasma concentration (Cmax)

  From the day of first dose to 30 days after last dose of CS1003

• Time to reach maximum plasma concentration (Tmax)

  From the day of first dose to 30 days after last dose of CS1003

• Terminal elimination half-life (t1/2)

  From the day of first dose to 30 days after last dose of CS1003

• Disease assessment by CT/MRI scan

  To be performed every 9 weeks during treatment period (up to 2 years) and within 30 days after last dose of CS1003

Study Arms (2)

CS1003

EXPERIMENTAL

Biological: CS1003

CS1003 + regorafenib

EXPERIMENTAL

Biological: CS1003; Drug: Regorafenib

Interventions

CS1003 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 DRUG

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

CS1003 + regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG performance status of 0 or 1.
• 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.
• Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
• Life expectancy ≥ 3 months.
• Subject must have adequate organ function.
• Use of effective contraception (males and females).

You may not qualify if:

• Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
• Subjects with active autoimmune diseases or history of autoimmune diseases.
• 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.
• 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.
• Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
• Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment within 2 weeks prior to the first dose of CS1003.
• 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.
• Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to the first dose of CS1003.
• Receipt of live vaccine within 28 days prior to the first dose of CS1003.
• History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
• History of HIV infection.
• Subjects with active Hepatitis B and C infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring therapy.
• Subjects with active infection of tuberculosis.
• Subjects with signs or symptoms of any active infection requiring systemic therapy.
• History of organ transplantation.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

Related Publications (2)

• Gong J, Guo Y, Zhang Y, Ba Y, Chen T, Li W, Zhou C, Wang M, Yang H, Zhou Y, Cai Q, Wang Z, Huang G, Zhang W, Su R, Cai Z, Yue Z, Dou J, Li P, Wu R, Tse AN, Shen L. A Phase 1a/1b Dose Escalation/Expansion Study of the Anti-PD-1 Monoclonal Antibody Nofazinlimab in Chinese Patients with Solid Tumors or Lymphoma. Target Oncol. 2024 Sep;19(5):723-733. doi: 10.1007/s11523-024-01091-8. Epub 2024 Sep 4.

  PMID: 39231855 DERIVED

• Day D, Park JJ, Coward J, Markman B, Lemech C, Kuo JC, Prawira A, Brown MP, Bishnoi S, Kotasek D, Strother RM, Cosman R, Su R, Ma Y, Yue Z, Hu HH, Wu R, Li P, Tse AN. A first-in-human phase 1 study of nofazinlimab, an anti-PD-1 antibody, in advanced solid tumors and in combination with regorafenib in metastatic colorectal cancer. Br J Cancer. 2023 Nov;129(10):1608-1618. doi: 10.1038/s41416-023-02431-7. Epub 2023 Sep 20.

  PMID: 37731023 DERIVED

MeSH Terms

Interventions

CS-1003; regorafenib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 23, 2018
• Study Start: May 9, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

AU (1)