Malignant Neoplasm of Digestive SystemPhase 1NCT05639153

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

A Phase 1 study testing DR30303 in people with Malignant Neoplasm of Digestive System, run by Zhejiang Doer Biologics Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Malignant Neoplasm of Digestive System
What is being tested?: DR30303
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteChina
Study dates: 13 May 2022to 18 Mar 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 17Show fewer

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.
The investigator assesses that the subject is unable or unwilling to comply with the requirements of the research protocol.
Participated in other clinical studies within the past 4 Weeks.

Trial locations and contacts

1 site in 1 country.

China1 site

Sir Run Run Shaw Hospital，Zhejiang University School of Medicine
Hanzhou, Zhejiang, 311100

Other trials in China

About this study

Official title: An Open, Phase I, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors

Read the detailed description

This study is an open, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of DR30303 in patients with advanced solid tumors. The study is composed of two parts: part 1 is Dose escalation stage and part 2 is Dose expansion stage.

Conditions: Malignant Neoplasm of Digestive System
Being tested: DR30303
Keywords: Malignant neoplasm of digestive system
Medical subject headings: Digestive System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DR30303Drug
DR30303 dose level of escalation IV every 3 weeks (Q3W) Day 1, as well as dose expansion with recommended dose level from dose escalation.

Study groups in NCT05639153
Study group	Role	What they receive
DR30303	Experimental	DR30303 injection treatment. This phase 1 trial will include two stages, a dose escalation stage and an expansion stage. Receives: Drug: DR30303

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1：Incidence of dose limiting toxicities (DLTs)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 28 days following last dose

Secondary outcomes (14)

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
These measure are defined as the proportion of subjects with complete response (CR) or partial response (PR)
Measured: 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)
These measure are defined as the proportion of subjects with CR, PR and stable disease (SD)
Measured: 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)
These measure are defined as the duration from the first occurrence of confirmed CR or PR until the date of disease progression or death (from any cause)
Measured: 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
Defined as Proportion of subjects with CR, PR and duration of SD ≥ 12 weeks
Measured: 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
For subjects with CR, PR, or SD, duration was calculated from the first assessment as CR, PR, or SD until the date of disease progression or death (from any cause)
Measured: 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
Progression free survival (PFS) per RECIST v1.1
These measure are defined as time from start of treatment to tumor progression or death from any cause
Measured: 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
6-month and 12-month survival rates
Measured: from date of first dose start until the date of first documented progression , 6 months，12 months whichever came first
Overall survival (OS) per RECIST v1.1
These measure are defined as time from start of treatment to death from any cause
Measured: from date of first dose start until the date of first documented progression or death from any cause，or the date of will receive DR30303 for 1 year whichever came first
Pharmacokinetic (PK) of DR30303: Maximum serum concentration (Cmax)
Measured: up to 28 days following last dose
PK of DR30303: Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last)
Measured: up to 28 days following last dose
PK of DR30303: Area Under the concentration-time Curve from time zero to infinity (AUC0-inf)
Measured: up to 28 days following last dose
PK of DR30303: Time of the maximum concentration (tmax)
Measured: up to 28 days following last dose
PK of DR30303: Terminal elimination half-life (t1/2)
Measured: up to 28 days following last dose
Immunogenicity by measurement of Incidence of anti-drug antibodies (ADA)
Measured: up to 28 days following last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 202218 Mar 2026

First posted6 Dec 2022
Study start13 May 2022
Primary completion30 Dec 2025
Study completion18 Mar 2026

Why it stopped: This trial was terminated voluntarily by the Sponsor for reasons related to its corporate strategic development, with no safety concerns or efficacy signals related to the investigational product identified.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malignant Neoplasm of Digestive SystemStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05639153
Sponsor's protocol ID: DR30303-101
Status last verified: Apr 2026
First submitted: 8 Nov 2022
Last updated: 13 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Neoplasm of Digestive System trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Phase I, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05639153
Acronym / sponsor ID: DR30303-101
Conditions: Malignant Neoplasm of Digestive System
Keywords: Malignant neoplasm of digestive system
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: This trial was terminated voluntarily by the Sponsor for reasons related to its corporate strategic development, with no safety concerns or efficacy signals related to the investigational product identified.
Enrolment: 13 participants (actual)
Lead sponsor: Zhejiang Doer Biologics Co., Ltd.Industry (pharma, biotech, devices)
Study start: 13 May 2022 (actual)
Primary completion: 30 Dec 2025 (actual)
Study completion: 18 Mar 2026 (actual)
First posted: 6 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DR30303	Experimental	Drug: DR30303DR30303 injection treatment. This phase 1 trial will include two stages, a dose escalation stage and an expansion stage.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DR30303DR30303 dose level of escalation IV every 3 weeks (Q3W) Day 1, as well as dose expansion with recommended dose level from dose escalation.	Drug	DR30303

Primary outcome

Part 1：Incidence of dose limiting toxicities (DLTs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 28 days following last dose

14 secondary outcomes

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Progression free survival (PFS) per RECIST v1.1
Time frame: 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
6-month and 12-month survival rates
Time frame: from date of first dose start until the date of first documented progression , 6 months，12 months whichever came first
Overall survival (OS) per RECIST v1.1
Time frame: from date of first dose start until the date of first documented progression or death from any cause，or the date of will receive DR30303 for 1 year whichever came first
Pharmacokinetic (PK) of DR30303: Maximum serum concentration (Cmax)
Time frame: up to 28 days following last dose
PK of DR30303: Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last)
Time frame: up to 28 days following last dose
PK of DR30303: Area Under the concentration-time Curve from time zero to infinity (AUC0-inf)
Time frame: up to 28 days following last dose
PK of DR30303: Time of the maximum concentration (tmax)
Time frame: up to 28 days following last dose
PK of DR30303: Terminal elimination half-life (t1/2)
Time frame: up to 28 days following last dose
Immunogenicity by measurement of Incidence of anti-drug antibodies (ADA)
Time frame: up to 28 days following last dose

Results and safety

The study was stopped early (reason given: This trial was terminated voluntarily by the Sponsor for reasons related to its corporate strategic development, with no safety concerns or efficacy signals related to the investigational product identified.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hongming Pan, MD,PhD principal investigator

Sir Run Run Shaw Hospital

Yanshan Huang, PhD study chair

Zhejiang Doer Biologics Co., Ltd.

Junfang Xu, MD study director

Huadong Medicine Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DR30303 in people with Malignant Neoplasm of Digestive System, run by Zhejiang Doer Biologics Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1：Incidence of dose limiting toxicities (DLTs) (time frame: up to 21 days following first dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05639153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.