Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

Innovent Biologics (Suzhou) Co. Ltd.260 enrolled

Overview

This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Solid Tumors or Lymphoma

Interventions

IBI363BIOLOGICAL

a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female subjects, ≥ 18 years 2. Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas 3. Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial. 4. Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Expected survival time ≥ 3 months. Exclusion Criteria: 1. 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. 2. 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. 3. Active uncontrolled bleeding or a known bleeding diathesis. 4. Subjects with massive pleural effusion or massive ascites.

Locations (1)

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Number of dose-limiting toxicity (DLT)

Incidence of dose-limiting toxicity (DLT) events

Time frame: 21 days during the first 3-week cycle

incidence of adverse enents (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)

AE is defined as an unexpected medical problem that happens during treatment with a drug or other therapy. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.

Time frame: up to 90 days after the last administration

Number of participants with abnormality in vital signs

Blood pressure, pulse, respiratory rate, and temperature will be assessed.

Time frame: up to 90 days after the last administration

Number of participants with abnormality in hematology parameters

Blood samples will be collected to evaluate hemoglobin, white blood cell (WBC) count, platelets and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)

Time frame: up to 90 days after the last administration

Number of participants with abnormality in clinical chemistry parameters

Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.

Central Contacts

Xiuzhi Yu

CONTACT

0512-69566088 xiuzhi.yu@innoventbio.com

Data from ClinicalTrials.gov

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Secondary Outcomes

maximum concentration (Cmax)

PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.

Time frame: Up to 2 years

area under the curve (AUC)

PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.

Time frame: Up to 2 years

clearance (CL)

PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate.

Time frame: Up to 2 years

half-life (t1/2) of IBI363

PK parameters to be evaluated for IBI363 including half-life (t1/2) will be determined when appropriate.

Time frame: Up to 2 years

volume of distribution (V)

PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.

Time frame: Up to 2 years

Objective response rate (ORR)