Trial Title:
The Efficacy and Safety of IBI363 in Solid Tumors
NCT ID:
NCT06081907
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Lenvatinib
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IBI363
Description:
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Arm group label:
IBI363 DL1
Other name:
IBI325
Intervention type:
Drug
Intervention name:
IBI363
Description:
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
Arm group label:
IBI363 DL2
Other name:
IBI325
Intervention type:
Drug
Intervention name:
IBI363
Description:
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
Arm group label:
IBI363 DL3
Other name:
Lenvatinib
Intervention type:
Drug
Intervention name:
IBI363
Description:
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
Arm group label:
IBI363 DL4
Other name:
Lenvatinib
Intervention type:
Drug
Intervention name:
IBI363
Description:
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).
Arm group label:
IBI363 DL10
Arm group label:
IBI363 DL11
Arm group label:
IBI363 DL5
Arm group label:
IBI363 DL6
Arm group label:
IBI363 DL7
Arm group label:
IBI363 DL8
Arm group label:
IBI363 DL9
Summary:
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.
Detailed description:
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. All the research data were collected follow the SAP.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yongchang Zhang
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongchang Yongchang Zhang, MD
Phone:
+8613873123436
Phone ext:
+8613873123436
Email:
zhangyongchang@csu.edu.cn
Start date:
December 25, 2023
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081907
