Advanced Cancer Clinical Trial
Official title:
A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
Verified date | February 2022 |
Source | CStone Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.
Status | Completed |
Enrollment | 108 |
Est. completion date | May 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 cstonera@cstonepharma.com |
Country | Name | City | State |
---|---|---|---|
Australia | Scientia Clinical Research Ltd | Randwick | New South Wales |
Lead Sponsor | Collaborator |
---|---|
CStone Pharmaceuticals |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | From the day of first dose to 30 days after last dose of CS1003 | ||
Secondary | Area under the plasma concentration-time curve (AUC) | From the day of first dose to 30 days after last dose of CS1003 | ||
Secondary | Maximum plasma concentration (Cmax) | From the day of first dose to 30 days after last dose of CS1003 | ||
Secondary | Time to reach maximum plasma concentration (Tmax) | From the day of first dose to 30 days after last dose of CS1003 | ||
Secondary | Terminal elimination half-life (t1/2) | From the day of first dose to 30 days after last dose of CS1003 | ||
Secondary | 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 | ||
Secondary | Anti-CS1003 antibody | From the day of first dose to 30 days after last dose of CS1003 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 | |
Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 |