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To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)

NCT05514158 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-18

No results posted yet for this study

Summary

This is a single-center, open-label, dose-escalation phase I clinical study.This study aimed to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical efficacy of RC48-ADC combined with RC98 in subjects with advanced gastric cancer.Which will provide a reference basis for dose confirmation in subsequent clinical studies.

Conditions

Interventions

DRUG

RC48-ADC

RC48 for injection is a novel antibody-drug conjugate, with a her-2-targeting antibody and a microtube inhibitor

DRUG

RC98

RC98 is a recombinant humanized IgG1 monoclonal antibody targeting programmed cell death-Ligand 1 (PD-L1)

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • yi Ba, ph.D · Tianjin Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2024-05-30
Completion
2024-09-30

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 NCT05514158 on ClinicalTrials.gov