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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/NCT05290597




Registration number
NCT05290597
Ethics application status
Date submitted
9/01/2022
Date registered
22/03/2022
Date last updated
8/09/2022

Titles & IDs
Public title
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas
Scientific title
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas
Secondary ID [1] 0 0
CIBI363A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Malignancies or Lymphomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IBI363

Experimental: IBI363 - Single arm


Other interventions: IBI363
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
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) and immune-related AEs (irAEs)
Timepoint [1] 0 0
up to 90 days after the last administration
Primary outcome [2] 0 0
Number of participants with abnormality in vital signs
Timepoint [2] 0 0
up to 90 days after the last administration
Primary outcome [3] 0 0
Number of participants with abnormality in hematology parameters
Timepoint [3] 0 0
up to 90 days after the last administration
Primary outcome [4] 0 0
Number of participants with abnormality in clinical chemistry parameters
Timepoint [4] 0 0
up to 90 days after the last administration
Primary outcome [5] 0 0
Number of participants with abnormality in routine urinalysis parameters
Timepoint [5] 0 0
up to 90 days after the last administration
Primary outcome [6] 0 0
Number of participants with abnormality in ECG parameters
Timepoint [6] 0 0
up to 90 days after the last administration
Primary outcome [7] 0 0
Number of dose-limiting toxicity (DLT)
Timepoint [7] 0 0
28 days during the first 4-week cycle
Secondary outcome [1] 0 0
maximum concentration (Cmax)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
area under the curve (AUC)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
clearance (CL)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
half-life (t1/2) of IBI363
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Objective response rate (ORR)
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
time to response (TTR)
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
duration of response (DoR)
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [8] 0 0
disease control rate (DCR)
Timepoint [8] 0 0
Up to 2 years
Secondary outcome [9] 0 0
progression-free survival (PFS)
Timepoint [9] 0 0
Up to 2 years
Secondary outcome [10] 0 0
6-month and 1-year PFS rate per RECIST v1.1 for subjects with solid tumors, and per Lugano 2014 for subjects with lymphomas
Timepoint [10] 0 0
Up to 2 years
Secondary outcome [11] 0 0
Overall survival (OS)
Timepoint [11] 0 0
through study completion, an average of 1 year
Secondary outcome [12] 0 0
survival rates (6-month and 1-year)
Timepoint [12] 0 0
Up to 2 years
Secondary outcome [13] 0 0
The incidence of ADA and NAb of IBI363
Timepoint [13] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
1. Male or female subjects, = 18 years

2. Subjects with a documented (histologically- or cytologically-proven) solid tumor
malignancy that is locally advanced or metastatic; subjects with documented lymphomas

3. Subjects with a malignancy (solid tumor or lymphoma) that is currently not amenable to
surgical intervention due to either medical contraindications or non-resectability of
the tumor

4. Subjects who are refractory to or intolerant to existing therapy(ies) known to provide
clinical benefit Note: Subjects may have received and failed prior therapy with a
PD-1/PD-L1 inhibitor and be considered eligible for this trial.

5. Subjects with measurable or non-measurable disease according to RECIST v1.1 or
standard criteria for lymphoma (Lugano 2014)

6. 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

7. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or lactating, or intending to become pregnant before, during,
or within 6 months after the last dose of study drug. Women of childbearing potential
(WOCBP) or fertile men with WOCBP partner(s), not using and not willing to use a
highly effective method of contraception.

2. Subjects with history of or known active seizure disorder, brain metastases, spinal
cord compression, or carcinomatous meningitis, or new evidence of brain or
leptomeningeal disease.

3. Subjects with:

- Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary
embolism (PE) within 4 weeks prior to first administration of study drug unless
adequately treated and considered by the Investigator to be stable.

- Active uncontrolled bleeding or a known bleeding diathesis.

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong

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, open-label, multicenter, dose-escalation 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 IBI363 (study drug) in subjects
with advanced, refractory solid malignancies or lymphomas.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05290597
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Morteza Aghmesheh
Address 0 0
Southern Medical Day Care Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Min Luo
Address 0 0
Country 0 0
Phone 0 0
00861087412310
Fax 0 0
Email 0 0
min.luo@innoventbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05290597