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Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor

NCT05009966 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-10-25

No results posted yet for this study

Summary

This is an open-label, dose escalation, dose expansion and extension cohort phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of SYSA1801

Conditions

  • Advanced Solid Tumor
  • Gastric Cancer (GC)
  • Gastroesophageal Junction (GEJ) Cancer
  • Pancreatic Cancer

Interventions

DRUG

SYSA1801 for injection

SYSA1801 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shen Lin, Ph.D · Peking University Cancer Hospital & Institute

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
2021-09-16
Primary Completion
2023-12-31
Completion
2024-06-30
FDA Drug
Yes

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 NCT05009966 on ClinicalTrials.gov