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First-In-Human Study of Bispecific Antibody MR001 In Subjects With Advanced Solid Tumors

NCT06134531 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-11-18

No results posted yet for this study

Summary

Phase 1 open-label study to evaluate the safety, tolerability and preliminary efficacy of bispecific antibody MR001 and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.

Conditions

Interventions

DRUG

MR001

Dose Level 1: 0.5 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 1 cycle Dose Level 2: 2 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle Dose Level 3: 6 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle Dose Level 4: 10 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle Dose Level 5: 15 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle Dose Level 6: 20 mg/kg Intravenously (IV) Frequency: administered on Day 1 of each cycle (every 3 weeks), 4 cycle

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Guoxin Li, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2026-07-31
Completion
2026-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06134531 on ClinicalTrials.gov