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Evaluation of SYS6005 in Patients With Advanced Malignant Tumor

NCT06958679 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-05-14

No results posted yet for this study

Summary

This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases. The escalation phase employs a BOIN design with accelerated titration across seven dose levels, featuring a 21-day DLT observation period in Cycle 1, with dose adjustments guided by a Safety Monitoring Committee. In the expansion phase, one or more dosing regimens and tumor types will be selected, and participants will receive SYS6005 R2PD for further exploration and validation. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria. Safety monitoring includes AEs, labs, and ECOG PS, while efficacy is assessed via imaging. PK and immunogenicity samples are collected, and survival is tracked quarterly until death or study end. The study aims to determine the maximum tolerance dose (MTD)/recommended phase 2 dose (RP2D) and characterize SYS6005's clinical profile.

Conditions

Interventions

DRUG

SYS6005

SYS6005 administered via IV infusion on , Day 1 of each 21-day cycle

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Principal Investigators

  • Qiu Lugui, Ph.D · Institute of hematology & blood disease hospital, Chinese academy of medical sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2027-01-30
Completion
2028-06-30

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 NCT06958679 on ClinicalTrials.gov