The Efficacy and Safety of IBI363 in Solid Tumors. (Promise)

January 6, 2024 updated by: Yongchang Zhang, Hunan Province Tumor Hospital

A Prospective, Multi-cohort Study on Efficacy and Safety of IBI363 for Advanced Solid Tumors

The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

430

Phase

  • 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 Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Yongchang Zhang
        • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sign written informed consent before implementing any trial-related procedures
  • Age ≥18 years old and ≤75 years old;
  • No limit on the gender;
  • Phase Ia: Enrollment priority is given to subjects with advanced non-small cell lung cancer and melanoma.
  • Phase Ib: This study comprises seven cohorts, including:
  • Cohort A: Patients with histopathologically confirmed advanced melanoma, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.
  • Cohort B: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.
  • Cohort C: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was disease stabilization for less than 6 months or disease progression.
  • Cohort D: Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was partial response or complete response lasting more than 6 months.
  • Cohort E: Patients with histologically confirmed advanced NSCLC, who have undergone NGS testing confirming the presence of an ALK fusion mutation and have previously failed standard treatment.
  • Cohort F: Patients with histological or cytological confirmation of advanced NSCLC who harboring EGFR mutation and failed standard treatment.
  • Cohort G: Patients with histological or cytological confirmation of advanced NSCLC and failed standard treatment with rare mutations, including but not limited to ROS1, BRAF V600E, METex14 skipping, HER2, NTRK, and RET fusion.
  • Tumor assessment according to RECIST v1.1, at least one measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • 1. Known history of seizures, active central nervous system metastasis, spinal cord compression, carcinomatous meningitis, history of meningeal metastasis, and newly diagnosed brain metastasis or meningeal metastasis.
  • a) Subjects who have previously received treatment for central nervous system metastases must meet all of the following criteria to be eligible for this study:
  • Completed treatment for central nervous system metastases (e.g., whole-brain radiation therapy, stereotactic radiosurgery, or equivalent treatment) at least 14 days before the first dose of the investigational drug.
  • Post-treatment repeat imaging confirmed no evidence of new brain metastases or enlargement of existing brain metastatic lesions (with an interval of ≥4 weeks and using the same imaging technique as the pre-treatment head imaging).

  • No requirement for steroid treatment and stable symptoms for at least 14 days before the first dose of the investigational drug.

    b) Subjects who have not previously received treatment for central nervous system metastases must meet all of the following criteria to be eligible for this study:

  • No symptoms related to central nervous system metastases.
  • Investigator assessment that immediate treatment for central nervous system metastases is not required.
  • A maximum of three central nervous system metastatic lesions, with each lesion having a maximum diameter of ≤5 mm.

  • 2. Significant cardiovascular and cerebrovascular diseases, including:

    1. Requiring medical intervention due to ventricular arrhythmias or other uncontrolled arrhythmias, such as treatment with anti-arrhythmic drugs.
    2. Severe conduction disturbances (e.g., third-degree atrioventricular block).
    3. HR-corrected QT interval (QTc interval, calculated using the Fridericia method) ≥480 ms.
    4. Uncontrolled hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg), a history of hypertensive crisis, or hypertensive encephalopathy.
    5. A history of myocarditis.
    6. Symptomatic congestive heart failure (New York Heart Association functional classes II-IV) or cardiac ultrasound findings indicating left ventricular ejection fraction (LVEF) <50%.
    7. Any arterial thrombosis, embolism, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident) within 6 months prior to the first dose of the investigational drug.
    8. History of deep venous thrombosis or any other serious thromboembolic event within the 3 months before enrollment (implantable venous access port or catheter-related thrombosis, or superficial venous thrombosis are not considered "serious" thromboembolic events).

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI363 DL5
Patients with histopathologically confirmed advanced melanoma, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL6
Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment and CD73 ≥++ confirmed by IHC.
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL7
Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was disease stabilization for less than 6 months or disease progression.
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL8
Patients with histopathologically confirmed advanced NSCLC, who have failed PD-1/PD-L1 treatment, and whose best response during PD-1/PD-L1 treatment was partial response or complete response lasting more than 6 months.
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL9
Patients with histologically confirmed advanced NSCLC, who have undergone NGS testing confirming the presence of an ALK fusion mutation and have previously failed standard treatment.
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL10
Patients with histological or cytological confirmation of advanced NSCLC who harboring EGFR mutation and failed standard treatment.
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL11
Patients with histological or cytological confirmation of advanced NSCLC and failed standard treatment with rare mutations, including but not limited to ROS1, BRAF V600E, METex14 skipping, HER2, NTRK, and RET fusion.
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL1
IBI363 + IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL2
IBI363 + IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL3
IBI363 + Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Experimental: IBI363 DL4
IBI363 + Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Other Names:
  • IBI325
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Other Names:
  • Lenvatinib
Drug: IBI363
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 1 year
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
1 year
Adverse Event
Time Frame: Up to 90 days post last dose
Number of participants experiencing clinical and laboratory adverse events (AEs)
Up to 90 days post last dose

Collaborators and Investigators

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

Sponsor

Hunan Province Tumor Hospital

Collaborators

Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Nong Yang, Hunan Cancer Hospital
  • Principal Investigator: Yongchang Zhang, Hunan Cancer Hospital
  • Principal Investigator: Xiang Chen, Xiangya Hospital of Central South University
  • Principal Investigator: Hong Liu, Xiangya Hospital of Central South University

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)

December 25, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 7, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBI-363

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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