Clinical trial NCT05370755: A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
Official title: A Phase Ia /Ib Dose Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Patients With Advanced Solid Tumors
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Antibody in Patients with Advanced Solid Tumors.


Eligibility criteria: Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
2. Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
3. At least one measurable lesion according to RECIST 1.1.

Exclusion Criteria:

1. 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;
2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
3. Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
4. Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
5. 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.

Primary outcomes:
measure: The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0
timeFrame: through study completion, an average of 2 years
measure: Dose-Limiting Toxicities (DLTs)
timeFrame: through study completion, an average of 2 years
measure: Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: The maximum plasma concentration observed (Cmax)
timeFrame: through study completion, an average of 2 years
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: through study completion, an average of 2 years
measure: Elimination half-life (t1/2)
timeFrame: through study completion, an average of 2 years
measure: Area under plasma concentration-time curve (AUC0-t and AUC0-∞)
timeFrame: through study completion, an average of 2 years
measure: Apparent clearance (CL/F)
timeFrame: through study completion, an average of 2 years
measure: Apparent volume of distribution (Vz/F)
timeFrame: through study completion, an average of 2 years
measure: The objective response rate (ORR)
timeFrame: through study completion, an average of 2 years
measure: Duration of response (DoR)
timeFrame: through study completion, an average of 2 years
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 2 years
measure: Overall survival (OS)
timeFrame: through study completion, an average of 3.5 years
Other outcomes:
measure: Pharmacodynamics
timeFrame: through study completion, an average of 2 years
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou
role: PRINCIPAL_INVESTIGATOR
References: