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

NCT05199519 | Completed Phase 1

• 1 other identifier: CIBI345Y001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

CLDN18.2 Positive Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

  up to 2 years

Secondary Outcomes (14)

• Objective Response Rate (ORR) according to RECIST version 1.1

  up to 2 years

• Duration of Response (DOR) according to RECIST version 1.1

  up to 2 years

• Disease Control Rate (DCR) according to RECIST version 1.1

  up to 2 years

• Time to Response (TTR) according to RECIST version 1.1

  up to 2 years

• Progression-Free Survival (PFS) according to RECIST version 1.1

  up to 2 years

Study Arms (1)

IBI345

OTHER

Single arm

Drug: IBI345

Interventions

IBI345 DRUG

IBI345 CAR-T cell injection by intravenous infusion

IBI345

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participating in another interventional clinical study, other than observational (non-interventional) clinical study or in the survival follow-up phase of the interventional study.
• Received any antitumor drug within 2 weeks prior to apheresis or initial administration of the investigational drug.
• Use of immunosuppressive drugs within 1 week prior to apheresis or 2 weeks prior to initial administration of the investigational drug.
• Long-term systemic steroid or any other immunosuppressive drug therapy is required, not including inhaled steroid therapy.
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: January 20, 2022
• Study Start: December 13, 2021
• Primary Completion: October 29, 2022
• Study Completion: January 19, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)