Trial Title:
A Study of IBI363 in Subjects With Advanced Melanoma
NCT ID:
NCT06081920
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
IBI363
Description:
IBI363 monotherapy
Arm group label:
IBI363
Summary:
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability,
and efficacy of IBI363 in advanced melanoma patients
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically and/or cytologically confirmed, unresectable, locally advanced or
metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th
edition staging III-IV). Progression or recurrence after at least first-line
systemic standard treatment.
2. At least one measurable lesion (target lesion) per RECIST v1.1.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
4. Life expectancy of 3 months or more.
5. Female subjects of childbearing age or male subjects whose partners are female
subjects of childbearing age agree to strictly adopt effective contraceptive
measures throughout the entire treatment period and 6 months after the treatment
period.
Exclusion Criteria:
1. Pregnant or lactating subjects, or subjects who plan to conceive before, during, or
within 6 months after the last dose of the study drug.
2. Active or symptomatic central nervous system metastasis.
3. At baseline (within 7 days before the first administration of the study drug), there
were any hematological abnormalities as follows: hemoglobin<90 g/L; Absolute
neutrophil count (ANC)<1.5 × 109/L; Platelet count<100 × 109/L.
4. At baseline (within 7 days prior to first administration), there were any serum
biochemical abnormalities as follows: Total bilirubin>1.5 × ULN; AST or ALT>3 × ULN;
If it is tumor liver metastasis, AST or ALT>5.0 × ULN; Serum creatinine>1.5 × ULN or
CCr<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body
weight); Albumin<30 g/L.
5. At baseline (within 7 days before first administration), there were any coagulation
parameter abnormalities as follows: INR>1.5 × ULN (>3 if receiving anticoagulant
therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin
time (aPTT))>1.5 × ULN (>3 if receiving anticoagulant therapy with stabilizer
dosage) × ULN).
6. History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4
weeks prior to the first administration of the investigational drug, unless
sufficient treatment has been given and the investigator believes that the condition
is stable.
7. Uncontrolled bleeding or known tendency to bleed.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo
Phone:
13911233048
Email:
guoj307@126.com
Facility:
Name:
Peking University Cancer Hospital & Institute, Beijing, China,
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo
Phone:
13911233048
Email:
guoj307@126.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Chen
Phone:
18950395132
Email:
chenyu1980@fjmu.edu.cn
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianan Li
Phone:
18874933879
Email:
lixianan2001@163.com;puxingxiang@hnca.org.cn
Contact backup:
Last name:
Xingxiang Pu
Phone:
15874180022
Facility:
Name:
The first affiliated hospital of Nanchang university
Address:
City:
Nanchang
Zip:
330052
Country:
China
Status:
Recruiting
Contact:
Last name:
Ling Zhang
Phone:
13672215566
Email:
zhang_l202@163.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Status:
Recruiting
Contact:
Last name:
Xueying Zhang
Phone:
13304329877
Email:
554597526@qq.com
Facility:
Name:
The first hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Di Wu
Phone:
13944888991
Email:
wudi888991@163.com
Facility:
Name:
Qilu Hospital of Shandong university
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Cuihua Yi
Phone:
18560082871
Email:
yicuihua@sdu.edu.cn
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
030032
Country:
China
Status:
Recruiting
Contact:
Last name:
Huijing Feng
Phone:
15834121235
Email:
doctorfh@sina.com
Facility:
Name:
Yunan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Contact:
Last name:
Ke Li
Phone:
13888052830
Email:
likelikelike@162.com
Start date:
October 19, 2023
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081920
