CLDN18.2 Positive Solid TumorsPhase 1NCT05199519

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

A Phase 1 study testing IBI345 in people with CLDN18.2 Positive Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: CLDN18.2 Positive Solid Tumors
What is being tested?: IBI345
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteChina
Study dates: 13 Dec 2021to 19 Jan 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: 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

Conditions: CLDN18.2 Positive Solid Tumors
Being tested: IBI345

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IBI345Drug
IBI345 CAR-T cell injection by intravenous infusion

Study groups in NCT05199519
Study group	Role	What they receive
IBI345	Other	Single arm Receives: Drug: IBI345

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: up to 2 years

Secondary outcomes (14)

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: up to 2 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.
Measured: 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.
Measured: up to 2 years
Peak Plasma Concentration (Cmax)
Measured: up to 1 years
Area under theplasma concentration versus time curve (AUC)
Measured: up to 1 years
Time of maximum drug concentration in hours [Tmax]
Measured: up to 1 years
Elimination half-life in hours [t1/2]
Measured: up to 1 years
Clearance (CL)
Measured: up to 1 years
Distribution Volume (Vd)
Measured: up to 1 years
Number of Participants With anti-drug antibody (ADA)
Measured: up to 1 years
Number of Participants With Neutralizing Antibodies (NAbs)
Measured: up to 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 202119 Jan 2023

First posted20 Jan 2022
Study start13 Dec 2021
Primary completion29 Oct 2022
Study completion19 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CLDN18.2 Positive Solid TumorsStudies of the same condition, open and under way.
More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05199519
Sponsor's protocol ID: CIBI345Y001
Status last verified: May 2023
First submitted: 28 Nov 2021
Last updated: 24 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
Advanced Solid Tumors
RecruitingEarly Phase 1
A IIT Study of 177Lu-DOTA-SNA040
Advanced Solid Tumors (Such as Gastric Cancer), Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction)
RecruitingPhase 1
SG1906 for CLDN18.2-Positive Solid Tumors
Locally Advanced Unresectable or Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase I/II Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors
Claudin 18.2, Solid Tumor Malignancies
RecruitingEarly Phase 1
An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors
CLDN18.2 Positive Solid Tumors

All CLDN18.2 Positive Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345 in Patients With CLDN18.2-positive Solid Tumors
ClinicalTrials.gov ID: NCT05199519
Acronym / sponsor ID: CIBI345Y001
Conditions: CLDN18.2 Positive Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 13 Dec 2021 (actual)
Primary completion: 29 Oct 2022 (actual)
Study completion: 19 Jan 2023 (actual)
First posted: 20 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IBI345	Other	Drug: IBI345Single arm

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IBI345IBI345 CAR-T cell injection by intravenous infusion	Drug	IBI345

Primary outcome

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

14 secondary outcomes

Objective Response Rate (ORR) according to RECIST version 1.1
Time frame: up to 2 years
Duration of Response (DOR) according to RECIST version 1.1
Time frame: up to 2 years
Disease Control Rate (DCR) according to RECIST version 1.1
Time frame: up to 2 years
Time to Response (TTR) according to RECIST version 1.1
Time frame: up to 2 years
Progression-Free Survival (PFS) according to RECIST version 1.1
Time frame: up to 2 years
Overall Survival (OS) according to RECIST version 1.1
Time frame: up to 2 years
Peak Plasma Concentration (Cmax)
Time frame: up to 1 years
Area under theplasma concentration versus time curve (AUC)
Time frame: up to 1 years
Time of maximum drug concentration in hours [Tmax]
Time frame: up to 1 years
Elimination half-life in hours [t1/2]
Time frame: up to 1 years
Clearance (CL)
Time frame: up to 1 years
Distribution Volume (Vd)
Time frame: up to 1 years
Number of Participants With anti-drug antibody (ADA)
Time frame: up to 1 years
Number of Participants With Neutralizing Antibodies (NAbs)
Time frame: up to 1 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
Individual participant dataSharing planned: No

Related trials for CLDN18.2 Positive Solid Tumors

RecruitingPhase 1/2
A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
Advanced Solid Tumors
RecruitingEarly Phase 1
A IIT Study of 177Lu-DOTA-SNA040
Advanced Solid Tumors (Such as Gastric Cancer), Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction)
RecruitingPhase 1
SG1906 for CLDN18.2-Positive Solid Tumors
Locally Advanced Unresectable or Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase I/II Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors
Claudin 18.2, Solid Tumor Malignancies
RecruitingEarly Phase 1
An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors
CLDN18.2 Positive Solid Tumors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI345 in people with CLDN18.2 Positive Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05199519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.