IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

January 23, 2025 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

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 (Estimated)

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.
250

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 Contact Backup

Study Locations

  • Australia
    • New South Wales
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Cancer Research SA
        • Contact:
  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Not yet recruiting
        • Shanghai East Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Male or female participants ≥ 18 years old;
  2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  3. Has an anticipated life expectancy of ≥ 12 weeks;
  4. Adequate bone marrow and organ function:
  5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
  6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Key Exclusion Criteria:

  1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
  2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
  3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
  4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
  5. Known symptomatic central nervous system (CNS) metastases.
  6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
  7. History of endotracheal or gastrointestinal stent implantation;
  8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
  9. Esophageal or gastric varices requiring immediate intervention;
  10. Not eligible to participate in this study at the discretion of the investigator;
  11. Do not have adequate treatment washout period before study drug administration. -

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: Open-label: IBI3001 monotherapy
Drug: IBI3001

The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study.

IBI3001 is proposed to be administered by intravenous infusion (IV)

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
Number of subjects with adverse events
Time Frame: 24 months
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
24 months
Number of subjects with clinically significant changes in physical examination results
Time Frame: 24 months
Clinically significant abnormal physical examination findings reported by the investigator.
24 months
Number of subjects with clinically significant changes in vital signs
Time Frame: 24 months
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
24 months
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
Time Frame: 24 months
Dose limiting toxicity (DLT) to establish MTD or RP2D
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
Objective response rate (ORR)
Time Frame: 24 months
ORR as evaluated per the RECIST v1.1 criteria
24 months
Duration of response (DoR)
Time Frame: 24 months
DoR as evaluated per the RECIST v1.1 criteria
24 months
Disease control rate (DCR)
Time Frame: 24 months
DCR as evaluated per the RECIST v1.1 criteria
24 months
Time to response (TTR)
Time Frame: 24 months
TTR as evaluated per the RECIST v1.1 criteria
24 months
Progression free survival (PFS)
Time Frame: 24 months
PFS as evaluated per the RECIST v1.1 criteria
24 months
Overall survival (OS)
Time Frame: 24 months
Overall survival.
24 months
Plasma concentration (Cmax) of IBI3001
Time Frame: 24 months
Plasma concentration of IBI3001 for single and multiple doses.
24 months
Area under the curve (AUC) of IBI3001
Time Frame: 24 months
AUC of IBI3001 for single and multiple doses
24 months
Time to maximum concentration (Tmax) of IBI3001
Time Frame: 24 months
Tmax of IBI3001 for single and multiple doses.
24 months
Clearance (CL) of IBI3001
Time Frame: 24 months
Clearance of IBI3001 from the plasma
24 months
Volume of distribution (V) of IBI3001
Time Frame: 24 months
Apparent volume of distribution of IBI3001
24 months
Half-life (T1/2) of IBI3001
Time Frame: 24 months
T1/2 of IBI3001 for single and multiple doses
24 months
Immunogenicity of IBI3001
Time Frame: 24 months
Incidence of anti-drug (IBI3001) antibody
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.
January 10, 2025

Primary Completion (Estimated)

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.
December 31, 2026

Study Completion (Estimated)

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 31, 2027

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).
April 1, 2024

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.
April 1, 2024

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.
April 5, 2024

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.
March 25, 2025

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.
January 23, 2025

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.
January 1, 2025

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.
  • CIBI3001A101

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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