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A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors

NCT07744763 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-08-04

No results posted yet for this study

Summary

This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors.

Conditions

Interventions

DRUG

SYS6041

Farletuzumab-exatecan antibody-drug conjugate targeting human FRα

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2027-03-28
Completion
2027-03-31

Countries

  • China

Study Locations

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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 NCT07744763 on ClinicalTrials.gov