A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- BL-M07D1
- Conditions
- HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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 in patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent and follow the requirements of the protocol;
- •No gender limit;
- •Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
- •Expected survival time ≥3 months;
- •Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology;
- •Provide tumor tissue samples within 2 years for detection of biomarkers such as HER2;
- •Must have at least one measurable lesion according to RECIST v1.1 definition;
- •ECOG 0 or 1;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
Exclusion Criteria
- •Major surgery within 4 weeks before the first dose, palliative radiotherapy within 2 weeks before the first dose, etc;
- •Prior ADC drug therapy with camptothecin derivative as toxin;
- •The history of severe cardiovascular and cerebrovascular diseases in the past six months;
- •Serious impairment of lung function due to pulmonary diseases;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Other primary malignancies diagnosed within 5 years before the first dose;
- •Poorly controlled hypertension;
- •A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or suspected to have such a condition during screening;
- •Patients with active central nervous system metastases;
- •Patients who are allergic to any excipients of the trial drug;
Arms & Interventions
Study treatment
Participants received BL-M07D1+PD-1 monoclonal antibody in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Intervention: BL-M07D1
Study treatment
Participants received BL-M07D1+PD-1 monoclonal antibody in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Intervention: PD-1 monoclonal antibody
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Recommended Phase II Dose (RP2D)
Time Frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1.
Secondary Outcomes
- Progression-free Survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)