Study of IBI323 in Patients With Advanced Malignancies

September 14, 2022 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IBI323 in Participants With Advanced Malignancies

The purpose of this study is to evaluate safety, tolerability and efficacy of IBI323(anti-LAG-3/PD-L1) or in combination with chemotherapy in participants with advanced malignancies. Another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of IBI323

Study Overview

Status

Status

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

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 (Anticipated)

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.
322

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
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shang Hai Pulmonary Hospital
        • Contact:

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Phase Ia Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment Phase Ib cohort A Patients with IO-refractory advanced NSCLC cohort B Patients with IO-naive advanced NSCLC who have failed standard treatment cohort C Patients with advanced NSCLC who have no prior treatment and PD-L1 TPS≥1% cohort D Patients with ES-SCLC or G3 neuroendocrine tumors who have failed standard treatment cohort E Patients with advanced MPM who have failed standard treatment cohort F Patients with advanced UC who have failed standard treatment cohort G Patients with advanced nccRCC who have failed standard treatment cohort H Patients with advanced HCC who have failed standard treatment cohort I Patients with advanced NPC who have failed standard treatment cohort J Patients with advanced CC or HNSCC who have failed standard treatment cohort K Patients with advanced GC or GEJC with HER2 negative who have no prior treatment cohort L Patients with advanced TNBC who have failed standard treatment
  2. Able to understand and willing to sign the ICF.
  3. 18 to 75 years old.
  4. Life expectancy at least 12 weeks.
  5. At least 1 measurable lesion per RECIST v1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Adequate organ and bone marrow functionAdequate organ and bone marrow function.

Exclusion Criteria:

  1. Prior treatment with any anti- LAG-3 antibody.
  2. Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
  3. Any investigational drugs received within 4 weeks prior to the first study treatment.
  4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
  5. Symptomatic CNS metastasis.
  6. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
  7. Pregnant or nursing females.

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.
Experimental: IBI323
Phase Ia enrolls patients with advanced malignancies. Phase Ib cohort A enrolls patients with NSCLC(IO-refractory), cohort B NSCLC(IO-naive), cohort C NSCLC(PD-L1 TPS≥1%), cohort D ES-SCLC or neuroendocrine tumors, cohort E MPM, cohort F UC, cohort G nccRCC, cohort H HCC, cohort I NPC, cohort J CC or HNSCC, cohort K GC or GEJC with HER2 negative, cohort L TNBC
Drug: IBI323
In phase Ia study, seven dose levels of IBI323 (0.03, 0.1, 0.3, 1, 3, 10 and 20mg/kg) will be evaluated. The DLT observation period is 28 days. IBI323 is administered by iv infusion day 1 of every 14 days. After dose escalation stage completed, two dose levels (10mg/kg and 20mg/kg) will be expanded to 20 patients each. In Phase Ib study, IBI323 is administered RP2D by iv infusion day 1 of every 14 days. IBI323 and chemotherapy will be administrated in cohort C and cohort K

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
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: 24 months
To evaluate the safety and tolerability of IBI323 [Adverse events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE), serious adverse event (SAE), dose-limiting toxicity (DLT) assessed by CTCAE v5.0]
24 months

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
Investigator Assessments of Overall Response Rate(ORR)
Time Frame: 24 months
RECIST v1.1 will be used to determine ORR by investigator
24 months
Disease Control Rate(DCR)
Time Frame: 24 months
RECIST v1.1 will be used to determine DCR by investigator
24 months
PFS (progression-free survival)
Time Frame: 24 months
RECIST v1.1 will be used to determine PFS by investigator
24 months
Anti-drug antibody (ADA)
Time Frame: 24 months
24 months

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.
June 29, 2021

Primary Completion (Anticipated)

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.
June 23, 2023

Study Completion (Anticipated)

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.
December 9, 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).
June 1, 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.
June 1, 2021

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.
June 7, 2021

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.
September 16, 2022

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.
September 14, 2022

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.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • CIBI323A101

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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