RecruitingPhase 1NCT04651348

A Clinical Study of MIL95 in Advanced Malignancies.

A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors

Sponsor

Beijing Mabworks Biotech Co., Ltd.

Enrollment

58 participants

Start Date

Jan 4, 2021

Study Type

INTERVENTIONAL

Conditions

Advanced Malignancies

Summary

This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design. The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days. Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests an experimental antibody drug called MIL95 in people with advanced cancers (solid tumors or lymphomas) that have not responded to previous treatments. MIL95 works by blocking a signal that cancer cells use to hide from the immune system. **You may be eligible if...** - You are 18 or older - You have a relapsed or refractory lymphoma or solid tumor - Your cancer has not spread to the brain - You are in good general health (ECOG 0–1) - You have a life expectancy of at least 3 months - You have not had another cancer in the last 5 years **You may NOT be eligible if...** - You have received any anti-cancer therapy within the past 4 weeks - You have previously been treated with a CD47- or SIRPα-targeting drug - You have active HIV, hepatitis B, or hepatitis C infection - You have autoimmune disease - You have a known history of hemolytic anemia (a condition where red blood cells break down too quickly) - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant Humanized Monoclonal Antibody MIL95

PART A :The patients confirming to the eligibility criteria will be assigned to the 4 dose groups (0.1mg/kg, 0.3mg/kg, 0.8mg/kg, 1.0mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL95 every week on Day 1 for a maximum of Twelve weeks. PART B:One recommended dose as a priming dose will be selected from 4 dose groups(0.1mg/kg、0.3mg/kg、0.8mg/kg、1.0mg/kg) based on results of PART A. Each patient will receive a priming dose of MIL95 on Day 1 Cycle 1.The patients will be assigned to the 5 maintenance dose groups (3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 45mg/kg, respectively) based on the sequence of inclusion. The maintenance dose was given on Day 8,15,22 Cycle 1 and on Day 1,8,15,22 Cycle 2+. Each cycle was 28 days.

Locations(1)

Beijing Cancer Hospital

Beijing, China

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NCT04651348

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