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A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors

NCT05564858 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-05-17

No results posted yet for this study

Summary

This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.

Conditions

Interventions

DRUG

FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia

FDA022-BB05, intravenously infusion, q3w

DRUG

FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib

FDA022-BB05, intravenously infusion, q3w

Sponsors & Collaborators

  • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xinghe Wang · Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2025-09-30
Completion
2025-11-30

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 NCT05564858 on ClinicalTrials.gov