A Clinical Study of MIL95 in Advanced Malignancies.

NCT04651348 | Recruiting Phase 1

• 1 other identifier: MIL95-CT101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events

  Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.

  up to 1year after enrollment

Secondary Outcomes (6)

• Pharmacokinetics:AUC

  up to 1year after enrollment

• Pharmacokinetics: Cmax

  up to 1year after enrollment

• Objective response rate (ORR)

  up to 1year after enrollment

• Duration of response (DoR)

  up to 1year after enrollment

• Progression free survival (PFS)

  up to 1year after enrollment

Study Arms (1)

MIL95

EXPERIMENTAL

Drug: Recombinant Humanized Monoclonal Antibody MIL95

Interventions

Recombinant Humanized Monoclonal Antibody MIL95 DRUG

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.

MIL95

Eligibility Criteria

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

You may qualify if:

• Adult patients, \>=18 years of age;
• Diagnosis of Refractory/relapsed lymphomas or solid tumor;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Life expectancy \>=3 months;
• Sufficient organ and bone marrow function;
• At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014);
• Able and willing to provide written informed consent and to comply with the study protocol.

You may not qualify if:

• Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
• Previous exposure to any drug targeting CD47 or SIRPα;
• Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
• Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
• Central nervous system metastasis;
• History of other primary malignant tumors in 5 years;
• Evidence of significant, uncontrolled concomitant disease;
• Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
• Active or suspected autoimmune diseases;
• Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments;
• Known history of hemolytic anemia;
• Known severe allergic reaction or/and infusion reaction to monoclonal antibody.

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Central Study Contacts

Yuqin Song, doctor

CONTACT

(+86)010-88121122; songyuqin622@163.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: November 11, 2020
• First Posted: December 3, 2020
• Study Start: January 4, 2021
• Primary Completion: December 8, 2022
• Study Completion: November 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-07

Locations

CN (1)