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)

NCT07554456 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-B01D1-315
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

  Up to approximately 24 months

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Progression-free survival (PFS)

  Up to approximately 24 months

• Time to Response (TTR)

  Up to approximately 24 months

Study Arms (3)

BL-B01D1 + tislelizumab + 5-FU

EXPERIMENTAL

Participants receive BL-B01D1 + tislelizumab + 5-FU in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-B01D1; Drug: Tislelizumab; Drug: 5-Fluorouracil

BL-B01D1 + tislelizumab

EXPERIMENTAL

Participants receive BL-B01D1 + tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-B01D1; Drug: Tislelizumab

cisplatin + paclitaxel/5-FU+ tislelizumab

ACTIVE COMPARATOR

Participants receive cisplatin + paclitaxel/5-FU+ tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: Tislelizumab; Drug: 5-Fluorouracil; Drug: Cisplatin; Drug: Paclitaxel

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1 + tislelizumab; BL-B01D1 + tislelizumab + 5-FU

Tislelizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1 + tislelizumab; BL-B01D1 + tislelizumab + 5-FU; cisplatin + paclitaxel/5-FU+ tislelizumab

5-Fluorouracil DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1 + tislelizumab + 5-FU; cisplatin + paclitaxel/5-FU+ tislelizumab

Paclitaxel DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

cisplatin + paclitaxel/5-FU+ tislelizumab

Cisplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

cisplatin + paclitaxel/5-FU+ tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

tislelizumab; Fluorouracil; Cisplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)