IMM2902, a HER2/SIRPα Bispecific mAb-Trap Antibody-receptor Fusion Protein, in Patients With HER2-expressing Advanced Solid Tumors

Overview

This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.

Full Title of Study: “A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients With HER2-Expressing Advanced Solid Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2023

Interventions

  • Drug: IMM2902
    • a recombinant bispecific monoclonal antibody with high affinity to the dual targets, HER2 and CD47

Arms, Groups and Cohorts

  • Experimental: IMM2902
    • IMM2902 Dose escalation: 0.03, 0.1, 0.25, 0.5, 1.0, 1.5, and 2.0 mg/kg through intravenous administration weekly up to 48 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Dose-Limiting Toxicity (DLT)
    • Time Frame: 48 Weeks
    • All toxicities will be graded according to the NCI CTCAE Version 5.0, which provides additional guidance for AEs not specifically mentioned in CTCAE. A DLTs is defined as any Grade 3 or greater AE that is assessed as related to study treatment that occurs during the 4-week DLTs observation period.
  • maximum tolerated dose (MTD) of IMM2902
    • Time Frame: 48 Weeks
    • Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
  • dose for expansion (RDE) of IMM2902
    • Time Frame: 48 Weeks
    • Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
  • Number of patients with Adverse Events(AEs)
    • Time Frame: 48 Weeks
    • Graded according to the NCI CTCAE V5.0

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years – Histologically or cytologically confirmed HER2-expressing advanced solid malignancy, who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available. – Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. – Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry. – Radiation therapy must be completed at least 2 weeks prior to study entry. Radiated lesions may not serve as measurable disease unless they have been radiated ≥12 months prior to enrollment. – Patients must have adequate organ and bone marrow function within 14 days of first dose of study drug administration Exclusion Criteria:

  • Prior anti-cancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 4 half-lives prior to IMM2902 dosing (up to a maximum of 4 weeks). – Anthracyclines within 3 months before first IMM2902 dosing or lifetime load exceeding 300 mg/m² adriamycin or equivalent. – Prior treatment with CD47 or SIRPα-targeting agents. – Trastuzumab, pertuzumab, lapatinib, tucatinib or T-DM1 within 3 weeks before first IMM2902 dosing. – Known active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. – Known inherited or acquired bleeding disorders. – History of hemolytic anemia or Evans syndrome, sickle cell disease, thalassemia, G6PD deficiency, hereditary spherocytosis, or hypersplenism in the last 3 months. – Current or prior use of immunosuppressive therapy within 14 days before the first dose of IMM2902. – Receipt of live attenuated vaccination within 30 days prior to registration.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cheng Huang, MD, Study Director, VP,Clinical Development
  • Overall Contact(s)
    • Qianwen Shao, +8617709180861, qianwen.shao@immuneonco.com

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