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)

Recruiting now · Phase 2/Phase 3

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT07554456

Run by

Sichuan Baili Pharmaceutical Co., Ltd.

People needed

90

Starts

2026-06-09

Expected to finish

2028-12-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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;
• 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 enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.

You may not qualify 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;
• 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;

Where it is running

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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