Trial Title:
A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
NCT ID:
NCT05636215
Condition:
Locally Advanced Unresectable or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/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:
IBI354
Description:
Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection
Arm group label:
IBI354
Summary:
This is a Phase 1/2, open-label, multicenter study designed to evaluate the safety,
tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum
administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to
explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with
locally advanced unresectable or metastatic solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female subjects, ≥ 18 years
2. Phase 1a : Has a pathologically documented advanced/unresectable or metastatic solid
tumor with HER2 alterations (IHC 1+, IHC 2+, IHC 3+ and/or ISH+ and/or NGS confirmed
mutant or amplification).
Phase 1b/2: Selected solid tumors enrolled Subjects with advanced GC/BC/BTC/CRC/Gyn
with her2 expression (IHC 1+, IHC 2+, IHC 3+ and/or ISH+).
3. Adequate bone marrow and organ function
4. Subjects, both male and female, who are either not of childbearing potential or who
agree to use at least one highly effective method of contraception during the study
(begin from screening or within 2 weeks prior to the first dose, whichever comes
first, and continue until 6 months after the last dose of study drug); Subjects,
both male and female, who are either not of childbearing potential or who agree to
use a highly effective method of contraception during the study beginning within 2
weeks prior to the first dose and continuing until 6 months after the last dose of
study drug
5. Subjects with the ability to understand and give written informed consent for
participation in this trial, including all evaluations and procedures as specified
by this protocol;
6. Have LVEF ≥ 50% by echocardiography (ECHO) within 28 days before study drug
administration.
Exclusion Criteria:
1. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the
anti-tumor regimens before the first administration of study drug, whichever is
shorter;
2. Plan to receive other antitumor therapy during the study excluding palliative
radiotherapy for the purpose of symptom (like pain) relief that must also do not
have impact on tumor assessment throughout the study;
3. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives
(whichever is longer) before first administration of the study drug.
4. Has adverse reactions resulting from previous antitumor therapies, which have not
resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia,
fatigue, pigmentation and other conditions with no safety risk according to
investigators' opinion) or baseline prior to first administration of the study drug;
5. Known symptomatic central nervous system (CNS) metastases.
6. History of pneumonia requiring corticosteroids therapy, or history of clinically
significant lung diseases or who are suspected to have these diseases by imaging at
screening period;
7. Uncontrolled diseases including:
- Uncontrolled infection requiring systematic antibiotics, antivirals or
antifungals within 2 weeks prior to first administration of the study drug;
- Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab
positive);
- HBsAg positive and/or HBcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥
2000 IU/mL or higher than lower limit of detection or HCV Ab positive with HCV
RNA>103 copies/mL;
- Active infection with COVID-19;
- Active tuberculosis infection, or still on anti-tuberculosis therapy or
received anti-tuberculosis therapy within 1 year prior to first administration
of the study drug;
- Active syphilis infection or latent syphilis requiring treatment;
- Symptomatic congestive heart failure Grade II-IV, symptomatic or uncontrolled
arrhythmias, QTc interval > 480 ms or personal or family history of congenital
long/short QT syndrome;
- SBP ≥ 160mmHg or DBP ≥ 100mmHg;
8. History of any arterial thromboembolic event within 6 months prior to the first
administration of study drug, including myocardial infarction, unstable angina
pectoris, cerebrovascular stroke or transient ischemic attack, etc.;
9. Risk of intestinal obstruction or perforation (including but not limited to: acute
diverticulitis, abdominal abscess, etc.) or a history of inflammatory bowel disease,
Crohn's disease, ulcerative colitis, or chronic diarrhea;
10. Do not have adequate treatment washout period before study drug administration,
defined as:
- Major surgery; ≥ 4 weeks.
- Radiation therapy；≥ 4 weeks (if palliative stereotactic radiation therapy, ≥ 2
weeks).
- Autologous transplantation；≥ 3 months.
- Hormonal therapy；≥ 2 weeks.
- Chemotherapy (including antibody drug therapy or other antitumor therapy)； ≥ 3
weeks.
- Immunotherapy； ≥ 4 weeks.
- Cytochrome P450 (CYP) 3A4 strong inhibitor；≥ 3 elimination half-lives of the
inhibitor.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Scientia Clinical Research Ltd
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Charlotte Lemech
Phone:
61293825807
Email:
Charlotte.lemech@scientiaclinicalresearch.com.au
Facility:
Name:
Sunshine Coast University Private Hospital
Address:
City:
Sunshine Coast
Zip:
4575
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Michelle Morris
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Daphne Day
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Shen Lin
Phone:
010-88196090
Email:
doctorshenlin@sina.cn
Facility:
Name:
Affiliated Cancer Hospital of Chongqing University
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Qi
Phone:
023-65311341
Email:
qizhou9128@163.com
Start date:
April 4, 2023
Completion date:
October 31, 2025
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/NCT05636215
