Clinical trial NCT05199519: Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345
Official title: A Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345 in Patients With CLDN18.2-positive Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CLDN18.2 Positive Solid Tumors
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 7
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 phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤75 years.
2. Histologically or cytologically confirmed CLDN18.2 positive patients with advanced gastric cancer or pancreatic cancer who failed standard therapy .
3. There are assessable lesions according to RECIST V1.1 (solid tumor efficacy evaluation criteria).
4. Expected survival time ≥12 weeks.
5. ECOG PS 0\~1.

Exclusion Criteria:

1. Participating in another interventional clinical study, other than observational (non-interventional) clinical study or in the survival follow-up phase of the interventional study.
2. Received any antitumor drug within 2 weeks prior to apheresis or initial administration of the investigational drug.
3. Use of immunosuppressive drugs within 1 week prior to apheresis or 2 weeks prior to initial administration of the investigational drug.
4. Long-term systemic steroid or any other immunosuppressive drug therapy is required, not including inhaled steroid therapy.
5. Receive live attenuated vaccine within 4 weeks prior to initial administration of the study drug or plan to receive live attenuated vaccine during the study period.
6. Toxicity (excluding alopecia, fatigue, and hematological toxicity) that did not return to equal to or lower than Grade 1 of NCI CTCAE V5.0 from previous antitumor therapy prior to initial administration of the investigational drug.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
timeFrame: up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR) according to RECIST version 1.1
timeFrame: up to 2 years
measure: Duration of Response (DOR) according to RECIST version 1.1
timeFrame: up to 2 years
measure: Disease Control Rate (DCR) according to RECIST version 1.1
timeFrame: up to 2 years
measure: Time to Response (TTR) according to RECIST version 1.1
timeFrame: up to 2 years
measure: Progression-Free Survival (PFS) according to RECIST version 1.1
timeFrame: up to 2 years
measure: Overall Survival (OS) according to RECIST version 1.1
timeFrame: up to 2 years
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 1 years
measure: Area under theplasma concentration versus time curve (AUC)
timeFrame: up to 1 years
measure: Time of maximum drug concentration in hours [Tmax]
timeFrame: up to 1 years
measure: Elimination half-life in hours [t1/2]
timeFrame: up to 1 years
measure: Clearance (CL)
timeFrame: up to 1 years
measure: Distribution Volume (Vd)
timeFrame: up to 1 years
measure: Number of Participants With anti-drug antibody (ADA)
timeFrame: up to 1 years
measure: Number of Participants With Neutralizing Antibodies (NAbs)
timeFrame: up to 1 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: