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

NCT05460767 | Unknown Phase 1

• 1 other identifier: CIBI363A102
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Solid Tumors or Lymphoma

Outcome Measures

Primary Outcomes (7)

• Number of dose-limiting toxicity (DLT)

  Incidence of dose-limiting toxicity (DLT) events

  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.

  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.

  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)

  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.

  up to 90 days after the last administration

• Number of participants with abnormality in routine urinalysis parameters

  Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.

  up to 90 days after the last administration

• Number of participants with abnormality in ECG parameters

  12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.

  up to 90 days after the last administration

Secondary Outcomes (14)

• maximum concentration (Cmax)

  Up to 2 years

• area under the curve (AUC)

  Up to 2 years

• clearance (CL)

  Up to 2 years

• half-life (t1/2) of IBI363

  Up to 2 years

• volume of distribution (V)

  Up to 2 years

Study Arms (1)

IBI363

EXPERIMENTAL

Single arm

Biological: IBI363

Interventions

IBI363 BIOLOGICAL

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

IBI363

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, ≥ 18 years
• Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas
• 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.
• Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Expected survival time ≥ 3 months.

You may not qualify if:

• 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.
• 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.
• Subjects with massive pleural effusion or massive ascites.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xiuzhi Yu

CONTACT

0512-69566088; xiuzhi.yu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 15, 2022
• Study Start: August 31, 2022
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

CN (1)