Clinical trial NCT05290597: A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies or Lymphomas
Official title: A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies or Lymphomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Malignancies or Lymphomas
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fortvita Biologics (USA)Inc.
First posted: 2022-03-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in vital signs
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in hematology parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in clinical chemistry parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in routine urinalysis parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in ECG parameters
timeFrame: up to 90 days after the last administration
measure: Number of dose-limiting toxicity (DLT)
timeFrame: 28 days during the first 4-week cycle
Secondary outcomes:
measure: maximum concentration (Cmax)
timeFrame: Up to 2 years
measure: area under the curve (AUC)
timeFrame: Up to 2 years
measure: clearance (CL)
timeFrame: Up to 2 years
measure: half-life (t1/2) of IBI363
timeFrame: Up to 2 years
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: time to response (TTR)
timeFrame: Up to 2 years
measure: duration of response (DoR)
timeFrame: Up to 2 years
measure: disease control rate (DCR)
timeFrame: Up to 2 years
measure: progression-free survival (PFS)
timeFrame: Up to 2 years
measure: 6-month and 1-year PFS rate per RECIST v1.1 for subjects with solid tumors, and per Lugano 2014 for subjects with lymphomas
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year
measure: survival rates (6-month and 1-year)
timeFrame: Up to 2 years
measure: The incidence of ADA and NAb of IBI363
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Kate.Wilkinson1@health.nsw.gov.au
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Southwest Private Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Cancer Care Wollongong
state: New South Wales
Study officials:
affiliation: Southern Medical Day Care Centre
name: Morteza Aghmesheh
role: PRINCIPAL_INVESTIGATOR
References: