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A Study of QL1706 in Subjects With Advanced Malignant Tumor

NCT04296994 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-04-10

No results posted yet for this study

Summary

This is an open-label, multicenter, Phase 1, ascending dose escalation study of QL1706 in subjects with advanced malignant tumor. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of QL1706. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of QL1706 in subjects with advanced malignant tumor. Part 2 of the study will further characterize the PK parameters for QL1706 in subjects with advanced malignant tumor.

Conditions

  • Advanced Malignant Tumor

Interventions

BIOLOGICAL

QL1706

QL1706（PSB205） is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, Doctor · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT04296994 on ClinicalTrials.gov