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Esophageal Squamous Cell CarcinomaPhase 2/3NCT07554456

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)

A Phase 2/3 study testing BL-B01D1, Tislelizumab and 5-Fluorouracil in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
BL-B01D1, Tislelizumab and 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
9 Jun 2026to Dec 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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 participation in the investigator's opinion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Lin Shen

    Recruiting

Other trials in China

About this study

Official title: A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 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)

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.

Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-B01D1Drug

    Also called iza-bren, izalontamab brengitecan, BMS-986507

    Administration by intravenous infusion for a cycle of 3 weeks.

  • TislelizumabDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • 5-FluorouracilDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • CisplatinDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • PaclitaxelDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT07554456
Study groupRoleWhat they receive
BL-B01D1 + tislelizumab + 5-FUExperimentalParticipants 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.
Receives: Drug: BL-B01D1; Drug: Tislelizumab; Drug: 5-Fluorouracil
BL-B01D1 + tislelizumabExperimentalParticipants 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.
Receives: Drug: BL-B01D1; Drug: Tislelizumab
cisplatin + paclitaxel/5-FU+ tislelizumabActive comparatorParticipants 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.
Receives: Drug: Tislelizumab; Drug: 5-Fluorouracil; Drug: Cisplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: Up to approximately 24 months

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

    Measured: Up to approximately 24 months

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Measured: Up to approximately 24 months

  3. Duration of Response (DOR)

    Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to approximately 24 months

  4. Progression-free survival (PFS)

    Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Measured: Up to approximately 24 months

  5. Time to Response (TTR)

    Time to Response (TTR) : For trial participants with objective response (BOR of CR or PR), the time from randomization to the first documented response (CR or PR, whichever occurs first).

    Measured: Up to approximately 24 months

  6. Treatment Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

    Measured: Up to approximately 24 months

  7. Anti-drug antibody (ADA)

    Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2026
  2. Study start9 Jun 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07554456
Sponsor's protocol ID
BL-B01D1-315
Status last verified
Jul 2026
First submitted
21 Apr 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BL-B01D1, Tislelizumab and 5-Fluorouracil in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07554456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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