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A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors

NCT05639153 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-04-13

No results posted yet for this study

Summary

This study is an open-label Phase 1, First in Human trial of DR30303, a recombinant humanized monoclonal antibody that targets Claudin18.2 (CLDN18.2). It is composed of humanized variable domain of heavy chain of antibody (VHH) fused with engineered immunoglobulin gamma-1(IgG1) Fc. It is being testing against advanced and/or metastatic solid tumors.

Conditions

  • Malignant Neoplasm of Digestive System

Interventions

DRUG

DR30303

DR30303 dose level of escalation IV every 3 weeks (Q3W) Day 1, as well as dose expansion with recommended dose level from dose escalation.

Sponsors & Collaborators

  • Zhejiang Doer Biologics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hongming Pan, MD,PhD · Sir Run Run Shaw Hospital

  • Yanshan Huang, PhD · Zhejiang Doer Biologics Co., Ltd.

  • Junfang Xu, MD · Huadong Medicine Co., Ltd.

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
2022-05-13
Primary Completion
2025-12-30
Completion
2026-03-18

Countries

  • China

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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 NCT05639153 on ClinicalTrials.gov