A Study Of IMM47 In Subjects With Advanced Solid Tumors

Oncology Clinical Trial

Official title: A Phase I, Open-Label, Multicenter, Dose-Escalation And Cohort-Expansion Study Of IMM47 In Subjects With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a first-in-human (FIH), open-label, multi-center, phase I study to evaluate the safety, tolerance, pharmacokinetics (PK), immunogenicity, preliminary anti-tumor activity, pharmacodynamics, and biomarker activity of IMM47 monotherapy in subjects with advanced solid tumors.

Clinical Trial Description

In phase Ia phase, approximately 17-48 eligible subjects with advanced solid tumors will be enrolled, and an accelerated titration method and the traditional "3+3" design method will be adopted to explore the safety, tolerability, PK, immunogenicity, and anti-tumor activity of 6 dose levels of IMM47: 5 μg/kg, 50 μg/kg, 250 μg/kg, 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg or higher, to determine the MTD and RP2D.

Accelerated dose cohorts: At the dose cohorts of 5 μg/kg and 50 μg/kg, one subject will be enrolled at first, and the conventional "3+3" design will be altered and the additional 2 or 5 subjects would be enrolled if any ≥ Grade 2 drug related toxicities are observed during the first 28-day cycle (DLT observational period).

"3+3" dose cohorts: Thereafter, at least three subjects will be enrolled in each dose cohort at the 250 μg/kg, 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg dose levels sequentially. There will be a minimum interval of 48 hours between the 1st and 2nd subjects being dosed in each "3+3" dose cohort. If no DLTs occur in a dose cohort of 3 subjects during the first cycle (DLT observational period), 3 subjects will be enrolled at the next higher dose level. If 1 of 3 subjects in a cohort experiences a DLT, an additional 3 subjects will be enrolled at that dose level. If only 1 of 6 subjects experiences a DLT, then 3 subjects will be enrolled at the next higher dose level. If 2 or more subjects experienced DLTs within a cohort, dose escalation will be halted and 3 more subjects will be enrolled at the previous lower (tolerated) dose level until that cohort has 6 evaluable subjects. Depending on toxicity, the dose deescalation to an intermediate dose may occur. Higher doses than 5.0 mg/kg may be explored under the decision of Safety Review Committee (SRC). A total of 6 subjects must be enrolled at the MTD (or the highest dose studied where no more than 1 of 6 subjects experiences a DLT if the MTD is not identified) and evaluated at the end of Cycle 1 before any subject is dosed in the expansion cohorts.

Continued dosing with IMM47 beyond the second cycle will be offered to subjects who do not experience disease progression or significant toxicity. Subjects who are benefiting from IMM47 will receive the treatment up to 12 cycles, at investigator's discretion. Subjects discontinuing the study treatment early for any reason will complete an end-of-treatment (EOT) visit within 30 (+7) days after the last dose, and a safety follow-up visit within 90 (±7) days after the last dose. If the subjects who achieve complete response (CR), partial response (PR), or stable disease (SD) with clinical benefit discontinue the investigational product, the follow-up visits will be completed every 12 weeks until disease progression, informed consent withdrawn by subject, death, or loss to follow-up, or end of study (whichever occurs first). Survival follow-up will be performed for a maximum of 2 years. ;

Related Conditions & MeSH terms

• Neoplasms
• Oncology

• NCT number: NCT05985083
• Study type: Interventional
• Source: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
• Contact: Qiying Lu, Dr.
• Phone: +86 21 38016387
• Email: qiying.lu@immuneonco.com
• Status: Recruiting
• Phase: Phase 1
• Start date: August 18, 2023
• Completion date: January 23, 2025