Status:
NOT_YET_RECRUITING
A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Patients With Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antib...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
- At least one measurable lesion according to RECIST 1.1.
Exclusion
- Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured;
- Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
- Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
- Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
- Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (\> grade 3 assessed by CTCAE 5.0).
- Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05370755
Start Date
May 31 2022
End Date
January 31 2026
Last Update
May 11 2022
Active Locations (1)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433