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

May 22, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: IBI345
Single arm
Drug: IBI345
IBI345 CAR-T cell injection by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 2 years
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.
up to 2 years
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).
up to 2 years
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).
up to 2 years
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.
up to 2 years
Peak Plasma Concentration (Cmax)
Time Frame: up to 1 years
up to 1 years
Area under theplasma concentration versus time curve (AUC)
Time Frame: up to 1 years
up to 1 years
Time of maximum drug concentration in hours [Tmax]
Time Frame: up to 1 years
up to 1 years
Elimination half-life in hours [t1/2]
Time Frame: up to 1 years
up to 1 years
Clearance (CL)
Time Frame: up to 1 years
up to 1 years
Distribution Volume (Vd)
Time Frame: up to 1 years
up to 1 years
Number of Participants With anti-drug antibody (ADA)
Time Frame: up to 1 years
up to 1 years
Number of Participants With Neutralizing Antibodies (NAbs)
Time Frame: up to 1 years
up to 1 years
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.
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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