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Trial Title:
A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors
NCT ID:
NCT05639153
Condition:
Malignant Neoplasm of Digestive System
Conditions: Official terms:
Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Conditions: Keywords:
Malignant neoplasm of digestive system
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DR30303
Description:
DR30303 dose level of escalation IV every 3 weeks (Q3W) Day 1, as well as dose expansion
with recommended dose level from dose escalation.
Arm group label:
DR30303
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Fully informed of this study and voluntarily sign informed consent form (ICF).
2. Aged 18 to 75 years, gender is not limited.
3. 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.
4. 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.
5. The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.
6. Expected survival ≥ 3 months.
7. Adequate organ function.
8. Referring to the RECIST 1.1 standard, there is at least one measurable lesion.
Exclusion Criteria:
1. Radical radiotherapy was performed within 12 weeks before the first dose of study
drug.
2. Subjects who have received other systemic anti-tumor therapy within 4 weeks before
the first dose of study drug.
3. Subjects who received or are scheduled to receive live attenuated vaccine within 4
weeks.
4. Received systemic steroids equivalent to >10mg/d prednisone within 2 weeks before
the first dose of study drug, except inhaled steroids.
5. 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.
6. Ever received any treatments targeting Claudin18.2.
7. Subject who have a history of allergy to any component in the DR30303.
8. Subject with uncontrolled intracranial metastases.
9. Uncontrollable pleural effusion, pericardial effusion and ascites effusion existed
before enrollment.
10. hepatitis B virus (HBV), hepatitis C virus (HCV), HIV or syphilis infection.
11. Diseases or associated risks that are judged by the investigator to be inappropriate
for enrollment, such as poorly controlled diabetes,etc.
12. Subjects with interstitial lung disease requiring treatment such as oral or
intravenous corticosteroids.
13. Subjects with previous or concomitant malignancies, with the following exceptions:
non- melanoma skin carcinoma in situ, superficial bladder cancer, etc.
14. 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.
15. Female patients who are breastfeeding.
16. The investigator assesses that the subject is unable or unwilling to comply with the
requirements of the research protocol.
17. Participated in other clinical studies within the past 4 Weeks.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shaw Hospital，Zhejiang University School of Medicine
Address:
City:
Hanzhou
Zip:
311100
Country:
China
Status:
Recruiting
Contact:
Last name:
Pan Hongming
Phone:
+86 571 8600 6922
Email:
shonco@sina.cn
Start date:
May 13, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Zhejiang Doer Biologics Co., Ltd.
Agency class:
Industry
Source:
Zhejiang Doer Biologics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05639153
