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CompletedNCT05199519Updated May 24, 2023

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

A Phase 1 interventional study of IBI345 in CLDN18.2 Positive Solid Tumors, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • CLDN18.2 Positive Solid Tumors
03

In context

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Other
    IBI345

    Single arm

    Drug: IBI345

Interventions

  • DrugIBI345

    IBI345 CAR-T cell injection by intravenous infusion

06

What researchers measure

Primary outcomes

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

    Time frame: up to 2 years

Secondary outcomes

  1. 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.

    Time frame: up to 2 years

  2. 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.

    Time frame: up to 2 years

  3. 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).

    Time frame: up to 2 years

  4. 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).

    Time frame: up to 2 years

  5. 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.

    Time frame: up to 2 years

  6. 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.

    Time frame: up to 2 years

  7. Peak Plasma Concentration (Cmax)

    Time frame: up to 1 years

  8. Area under theplasma concentration versus time curve (AUC)

    Time frame: up to 1 years

  9. Time of maximum drug concentration in hours [Tmax]

    Time frame: up to 1 years

  10. Elimination half-life in hours [t1/2]

    Time frame: up to 1 years

  11. Clearance (CL)

    Time frame: up to 1 years

  12. Distribution Volume (Vd)

    Time frame: up to 1 years

  13. Number of Participants With anti-drug antibody (ADA)

    Time frame: up to 1 years

  14. Number of Participants With Neutralizing Antibodies (NAbs)

    Time frame: up to 1 years

07

Study locations

1 site
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05199519
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Jan 20, 2022
Start date
Dec 13, 2021
Primary completion
Oct 29, 2022
Completion
Jan 19, 2023
Last update
May 24, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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