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Compares treatment options for Esophageal Squamous Cell Carcinoma
Official title A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)
ClinicalTrials.gov ID: NCT07554456
What this study is testing
What is BL-B01D1?
BL-B01D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Also referred to as iza-bren, izalontamab brengitecan.
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 trial is a registrational Phase II/III, randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with tislelizumab ± 5-FU in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
- Phase 3: a large, late-stage 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 form and agree to follow the protocol requirements;
- No gender restriction;
- Age ≥18 years and ≤75 years at the time of signing the informed consent form;
- Expected survival time ≥3 months;
- Patients with unresectable, locally advanced recurrent or metastatic first-line esophageal squamous cell carcinoma;
You likely can't join if
- Patients with esophageal squamous cell carcinoma whose pathology indicates the presence of non-squamous carcinoma components;
- Use of immunomodulatory drugs within 2 weeks prior to the first study drug administration;
- Prior use of an ADC drug whose small-molecule toxin is a topoisomerase I inhibitor;
- Patients with esophageal squamous cell carcinoma who are suitable for curative-intent local therapy;
- Receipt of curative-intent radiotherapy, major surgery, etc., within 4 weeks prior to study randomization;
- Ongoing long-term systemic corticosteroid therapy (e.g., \>10 mg/day prednisone) prior to the first dose;
See the full eligibility criteria
- Voluntarily sign the informed consent form and agree to follow the protocol requirements;
- No gender restriction;
- Age ≥18 years and ≤75 years at the time of signing the informed consent form;
- Expected survival time ≥3 months;
- Patients with unresectable, locally advanced recurrent or metastatic first-line esophageal squamous cell carcinoma;
- Must have at least one measurable target lesion as defined by RECIST v1.1;
- Must provide archived tumor tissue specimens from the primary or metastatic lesion within the past 3 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- No severe cardiac dysfunction; left ventricular ejection fraction ≥50%;
- Organ function levels must meet the specified requirements;
- Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
- Urine protein ≤1+ or \<1000 mg/24h;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must be negative, and the patient must not be breastfeeding; all...
- Patients with esophageal squamous cell carcinoma whose pathology indicates the presence of non-squamous carcinoma components;
- Use of immunomodulatory drugs within 2 weeks prior to the first study drug administration;
- Prior use of an ADC drug whose small-molecule toxin is a topoisomerase I inhibitor;
- Patients with esophageal squamous cell carcinoma who are suitable for curative-intent local therapy;
- Receipt of curative-intent radiotherapy, major surgery, etc., within 4 weeks prior to study randomization;
- Ongoing long-term systemic corticosteroid therapy (e.g., \>10 mg/day prednisone) prior to the first dose;
- Prior immunotherapy targeting PD-1, PD-L1, or PD-L2;
- History of severe heart disease or cerebrovascular disease;
- Prolonged QTc interval, complete left bundle branch block, etc.;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of active malignant tumor within 3 years prior to study randomization;
- Hypertension poorly controlled by two antihypertensive agents;
- Patients with poorly controlled blood glucose;
- History of interstitial lung disease (ILD)/interstitial pneumonitis requiring steroid therapy, etc.;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
- Presence of large serous cavity effusions or serous cavity effusions, etc.;
- Concomitant pulmonary diseases resulting in clinically severe respiratory function impairment;
- Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, thorax, neck, or pharynx;
- Tumor invasion or compression of the trachea or bronchi causing any clinical symptoms such as cough;
- Patients with esophageal fistula caused by tumor invasion of adjacent organs, or patients assessed by the investigator as being at risk of developing esophageal fistula;
- Patients with tracheal or esophageal stent placement due to any cause;
- Participants with clinically significant bleeding or an obvious bleeding tendency within 4 weeks prior to signing the informed consent form;
- BMI \< 18.5 kg/m² at screening, or weight loss ≥10% within 2 months prior to screening;
- Patients with active central nervous system metastases;
- Patients with a history of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient component of BL-B01D1;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Severe infection within 4 weeks prior to study randomization, etc.;
- History of severe neurological or psychiatric disorders;
- Patients with a history of substance abuse that precludes compliance with clinical trial requirements;
- Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;
- Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.;
- Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;
- Trial participants planning to receive or having received live vaccine within 28 days prior to the first dose;
- Pregnant or breastfeeding women;
- Presence of other serious physical conditions, laboratory abnormalities, or poor compliance that may increase the risk of study participation, interfere with study results, or make the patient unsuitable for study...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 Beijing, Beijing Municipality, 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.