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Trial Title:
A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT06423885
Condition:
HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Capecitabine
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-M07D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
PD-1 monoclonal antibody
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Oral administration for a cycle of 3 weeks.
Arm group label:
Study treatment
Summary:
This study is a multicenter, open-label, phase II clinical study to explore the safety
and efficacy of BL-M07D1+PD-1 monoclonal antibody and BL-M07D1+PD-1 monoclonal antibody+
capecitabine in patients with unresectable locally advanced or metastatic HER2-positive
gastric or gastroesophageal junction adenocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
4. Expected survival time ≥3 months;
5. Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma
confirmed by pathology;
6. Patients provided tumor tissue specimens as far as possible for the detection of
biomarkers such as HER2 and PD-L1 for exploratory retrospective analysis;
7. Must have at least one measurable lesion according to RECIST v1.1 definition;
8. ECOG 0 or 1;
9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by
NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Blood transfusion is not allowed within 14 days before the first use of study drugs,
and the use of colony-stimulating factors is not allowed, and the organ function
level must meet the requirements;
12. Coagulation function: international normalized ratio (INR) ≤1.5 and activated
partial thromboplastin time (APTT) ≤1.5×ULN;
13. Urine protein ≤2+ or ≤1000mg/24h;
14. Female subjects of childbearing potential, or male subjects with a fertile partner,
had to use highly effective contraception from 7 days before the first dose until 7
months after the dose. Female subjects of childbearing potential had to have a
negative serum pregnancy test within 7 days before the first dose.
Exclusion Criteria:
1. Anti-tumor therapy such as chemotherapy, biological therapy, and immunotherapy had
been used within 4 weeks or 5 half-lives before the first dose. Oral drugs such as
fluorouracil;
2. Prior ADC drug therapy with camptothecin derivative as toxin;
3. The history of severe cardiovascular and cerebrovascular diseases in the past six
months;
4. Serious impairment of lung function due to pulmonary diseases;
5. QT prolongation, complete left bundle branch block, III degree atrioventricular
block, frequent and uncontrollable arrhythmia;
6. Other primary malignancies diagnosed within 5 years before the first dose;
7. Poorly controlled hypertension;
8. A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or
suspected to have such a condition during screening;
9. Patients with active central nervous system metastases;
10. Patients who are allergic to any excipients of the trial drug;
11. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks
before study dosing;
12. Patients with massive or symptomatic effusions or poorly controlled effusions;
13. Severe systemic infection within 4 weeks before screening;
14. Active autoimmune and inflammatory diseases;
15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection
or hepatitis C virus infection;
16. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
17. A history of severe neurological or psychiatric illness;
18. Pregnant or lactating women;
19. The presence of other serious physical or laboratory abnormalities or poor
compliance may increase the risk of participating in the study risk, or interference
with the results of the study, and patients who were deemed by the investigators to
be unsuitable for participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Weijian Guo
Start date:
October 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06423885
