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

NCT05639153 | Terminated Phase 1

• 1 other identifier: DR30303-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Malignant neoplasm of digestive system

Outcome Measures

Primary Outcomes (5)

• Part 1：Incidence of dose limiting toxicities (DLTs)

  up to 21 days following first dose

• Part 1：Number, severity and duration of treatment-emergent adverse events (TEAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

  up to 28 days following last dose

• Part 1：Maximum Tolerated Dose (MTD) and/or Biological effective dose (BED) based on safety, tolerability, PK profile and preliminary efficacy data

  from date of last dose until the date of will receive DR30303 for 1 year or last documented progression，whichever occurs first

• Part 2: Recommended Phase 2 Dose (RP2D) based on safety, tolerability, PK profile, and preliminary efficacy data

  from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first

• Part 2: Number, severity and duration of treatment-emergent adverse events (TEAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

  up to 28 days following last dose

Secondary Outcomes (14)

• Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first

• Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first

• Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first

• Clinical Benefit Rate

  from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first

• Duration of disease control (DDC) per RECIST v1.1

  from date of first dose start until the date of first documented progression，or the date of death from any cause, or the date of will receive DR30303 for 1 year whichever came first

Study Arms (1)

DR30303

EXPERIMENTAL

DR30303 injection treatment. This phase 1 trial will include two stages, a dose escalation stage and an expansion stage.

Drug: DR30303

Interventions

DR30303 DRUG

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

DR30303

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully informed of this study and voluntarily sign informed consent form (ICF).
• Aged 18 to 75 years, gender is not limited.
• Part 1: Dose escalation stage - the subject have histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors who have failed or are intolerant to prior systemic therapy.
• Part 2: Dose expansion stage- CLDN18.2 positive confirmed by central laboratory locally advanced unresectable or metastatic gastric cancer (GC)/gastroesophageal junction (GEJ ) or Pancreatic cancer those who had failed or were intolerant to at least 1 line of systemic therapy.
• The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.
• Expected survival ≥ 3 months.
• Adequate organ function.
• Referring to the RECIST 1.1 standard, there is at least one measurable lesion.

You may not qualify if:

• Radical radiotherapy was performed within 12 weeks before the first dose of study drug.
• Subjects who have received other systemic anti-tumor therapy within 4 weeks before the first dose of study drug.
• Subjects who received or are scheduled to receive live attenuated vaccine within 4 weeks.
• Received systemic steroids equivalent to \>10mg/d prednisone within 2 weeks before the first dose of study drug, except inhaled steroids.
• Subjects who have undergone or are expected to undergo major surgery, or have severe unhealed wounds, etc. prior to the first dose of study drug.
• Ever received any treatments targeting Claudin18.2.
• Subject who have a history of allergy to any component in the DR30303.
• Subject with uncontrolled intracranial metastases.
• Uncontrollable pleural effusion, pericardial effusion and ascites effusion existed before enrollment.
• hepatitis B virus (HBV), hepatitis C virus (HCV), HIV or syphilis infection.
• Diseases or associated risks that are judged by the investigator to be inappropriate for enrollment, such as poorly controlled diabetes,etc.
• Subjects with interstitial lung disease requiring treatment such as oral or intravenous corticosteroids.
• Subjects with previous or concomitant malignancies, with the following exceptions: non- melanoma skin carcinoma in situ, superficial bladder cancer, etc.
• Clinically significant cardiovascular and cerebrovascular diseases within 6 months before the first dose of study drug, such as New York Heart Association (NYHA) class III or IV congestive heart failure, etc.
• Female patients who are breastfeeding.

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (1)

Sir Run Run Shaw Hospital，Zhejiang University School of Medicine

Hanzhou, Zhejiang, 311100, China

Location

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Officials

• Hongming Pan, MD,PhD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Yanshan Huang, PhD

  Zhejiang Doer Biologics Co., Ltd.

  STUDY CHAIR

• Junfang Xu, MD

  Huadong Medicine Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 6, 2022
• Study Start: May 13, 2022
• Primary Completion: December 30, 2025
• Study Completion: March 18, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)