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New treatment option for Esophageal Cancer
Official title A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
ClinicalTrials.gov ID: NCT06500052
What this study is testing
What is BL-M17D1?
BL-M17D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancer and other solid tumors.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- No gender limit;
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
- Expected survival time ≥3 months;
- The pathologic histology and/or cytology diagnosis of locally advanced or metastatic positive HER2 / low expression of the digestive tract tumor and...
You likely can't join if
- Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and...
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
- Other malignant tumors diagnosed within 5 years before the first dose;
- Hypertension poorly controlled by two antihypertensive drugs;
See the full eligibility criteria
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- No gender limit;
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
- Expected survival time ≥3 months;
- The pathologic histology and/or cytology diagnosis of locally advanced or metastatic positive HER2 / low expression of the digestive tract tumor and other solid tumor;
- Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
- 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%;
- Organ function level must meet the requirements;
- Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;
- Urine protein ≤2+ or ≤1000mg/24h;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All the patients (no...
- Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral...
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
- Other malignant tumors diagnosed within 5 years before the first dose;
- Hypertension poorly controlled by two antihypertensive drugs;
- Patients with poor glycemic control before the first dose;
- Have to hormone treatment of interstitial lung disease, or the current with ILD or suspected suffering from such diseases;
- Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large blood vessels;
- Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months;
- Patients with active central nervous system metastases;
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the excipients of BL-M17D1;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic therapy with serious infection within 4 weeks before informed consent; There were indications of pulmonary infection or active pulmonary inflammation within 2 weeks before informed...
- Participated in another clinical trial within 4 weeks before the first dose;
- Pregnant or lactating women;
- Patients with superior vena cava syndrome should not be rehydrated;
- A history of severe neurological or psychiatric illness;
- Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
- people with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection or presence of Crohn's disease, ulcerative colitis, or chronic disease Sexual diarrhea;
- Patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose;
- Other conditions for participation in the trial were not considered appropriate by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.