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Completed

NCT Number: NCT05199519

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

IBI345

Drug

IBI345 CAR-T cell injection by intravenous infusion

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

    Time frame: up to 2 years

    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.

  2. Duration of Response (DOR) according to RECIST version 1.1

    Time frame: up to 2 years

    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.

  3. Disease Control Rate (DCR) according to RECIST version 1.1

    Time frame: up to 2 years

    Defined as the proportion of subjects who have achieved CR, PR, or stable disease (duration of stable disease should be ≥3 months).

  4. Time to Response (TTR) according to RECIST version 1.1

    Time frame: up to 2 years

    Defined as the time from first dose to first documentation of objective response (either CR or PR).

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

    Time frame: up to 2 years

    Defined as the time from first dose to first documentation of radiographic disease progression or death due to any cause, whichever occurs first.

  6. Overall Survival (OS) according to RECIST version 1.1

    Time frame: up to 2 years

    Defined as the time from first dose to the date of death due to any cause.

  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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 20, 2022
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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