NCT05549557

IMM40H Phase I Dose Escalation and Expansion

An Open-label, Multi-center Phase I Clinical Study of IMM40H in Patients With Advanced Solid Tumor and Hematological Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is first-in-human, open-label, multi-center, dose-escalation (phase Ia) and cohort expansion (phase Ib) phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, immunogenicity, and antitumor activities of IMM40H in patients with advanced malignancies including solid tumor and hematological malignancies.

Detailed description

This study will include 16\~27 patients with advanced malignancies that have progressed after or have no response to previous standard treatments or for whom no standard treatments are available (including but not limited to melanoma, nasopharyngeal cancer, thymoma, RCC, colorectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, astrocytoma, ovarian cancer, AML, and lymphoma). The primary objective is to determine the maximum tolerated dosage (MTD) or recommended dose for expansion (RDE) by observing the safety and tolerability of IMM40H monotherapy. The adjusted "3 + 3" design will be adopted in this trial for dose escalation, with the starting dose of IMM40H at 0.3 mg/kg and the temporary maximum dose at 20 mg/kg. In the dose-escalation stage, a total of 5 dose levels will be designed:0.3, 1, 3, 10, 20 mg/kg, to determine MTD . For each subject in each dose group, the dose will be gradually increased according to the dose-escalation rules, and the observation period for dose-limiting toxicity (DLT) will be set to be 28 days after the first dose. Patients with CD70-positive malignancies to further evaluate the safety, PK characteristics, immunogenicity, and anti-tumor activity or preliminary efficacy of IMM40H dosing at MTD.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	IMM40H	IMM40H is a monoclonal antibody with a molecular generated from ImmuneOnco's antibody platform. IMM40H targets CD70 (a tumor cell marker).

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-10-01
• Completion: 2024-06-01
• First posted: 2022-09-22
• Last updated: 2022-09-22