Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345

A Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345 in Patients With CLDN18.2-positive Solid Tumors

A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors

Study Overview

• Status: Completed
• Conditions: CLDN18.2 Positive Solid Tumors
• Intervention / Treatment: Drug: IBI345

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jiahui Xu; Phone Number: +86 010 87705665; Email: jiahui.xu@innoventbio.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IBI345; Single arm	Drug: IBI345; IBI345 CAR-T cell injection by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) according to RECIST version 1.1	Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.	up to 2 years
Duration of Response (DOR) according to RECIST version 1.1	Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.	up to 2 years
Disease Control Rate (DCR) according to RECIST version 1.1	Defined as the proportion of subjects who have achieved CR, PR, or stable disease (duration of stable disease should be ≥3 months).	up to 2 years
Time to Response (TTR) according to RECIST version 1.1	Defined as the time from first dose to first documentation of objective response (either CR or PR).	up to 2 years
Overall Survival (OS) according to RECIST version 1.1	Defined as the time from first dose to the date of death due to any cause.	up to 2 years
Peak Plasma Concentration (Cmax)		up to 1 years
Area under theplasma concentration versus time curve (AUC)		up to 1 years
Time of maximum drug concentration in hours [Tmax]		up to 1 years
Elimination half-life in hours [t1/2]		up to 1 years
Clearance (CL)		up to 1 years
Distribution Volume (Vd)		up to 1 years
Number of Participants With anti-drug antibody (ADA)		up to 1 years
Number of Participants With Neutralizing Antibodies (NAbs)		up to 1 years
Progression-Free Survival (PFS) according to RECIST version 1.1	Defined as the time from first dose to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.	up to 2 years

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): October 29, 2022
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: November 28, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CIBI345Y001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No