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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05636215




Registration number
NCT05636215
Ethics application status
Date submitted
23/11/2022
Date registered
5/12/2022
Date last updated
12/12/2022

Titles & IDs
Public title
A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Scientific title
A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Secondary ID [1] 0 0
CIBI354A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Unresectable or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IBI354

Experimental: IBI354 - Single arm


Other interventions: IBI354
Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs).
Timepoint [1] 0 0
Up to 30 days after the last administration
Primary outcome [2] 0 0
Number of dose-limiting toxicity (DLT)
Timepoint [2] 0 0
21 days during the first cycle in Phase Ia
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
duration of response (DoR)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
progression-free survival (PFS)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
Up to 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/07/2025
Actual
Sample size
Target
444
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [2] 0 0
Sunshine Coast University Private Hospital - Sunshine Coast
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4575 - Sunshine Coast
Recruitment postcode(s) [3] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Innovent Biologics (Suzhou) Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05636215
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peng An
Address 0 0
Country 0 0
Phone 0 0
+86 18310080353
Fax 0 0
Email 0 0
alisa.an@innoventbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05636215