A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BL-B01D1 for patients with a type of cancer called recurrent or metastatic esophageal squamous cell carcinoma, which means the cancer has come back or spread after previous treatments. The goal is to find out if BL-B01D1 works better than standard chemotherapy chosen by doctors for these patients, especially those who have already tried another treatment that didn’t work. The study is currently looking for participants aged 18 and older who have been diagnosed with this type of cancer and have at least one measurable tumor.

To qualify for the trial, patients must be in generally good health, with their previous cancer treatments side effects mostly resolved. They should also be able to provide tissue samples from their tumors for research purposes. Participants will receive either BL-B01D1 or the chemotherapy of their doctor’s choice and will be monitored for side effects and how well the treatment is working. It's important to note that certain health conditions might prevent someone from joining the trial, so potential participants will be carefully screened. This study aims to offer hope for patients who have limited treatment options and to improve outcomes for those with this challenging cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign the informed consent and follow the requirements of the protocol;
• • 2. Age ≥18 years old;
• • 3. Expected survival time ≥3 months;
• • 4. Patients with recurrent or metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
• • 5. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
• • 6. Must have at least one measurable lesion according to RECIST v1.1 definition;
• • 7. ECOG 0 or 1;
• • 8. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• • 9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• • 10. No blood transfusion and no use of any cell growth factor drugs were allowed within 14 days before randomization, and the level of organ function had to be adequate;
• • 11. Urine protein ≤2+ or \< 1000mg/24h;
• • 12. A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal women who are likely to have children, and the result must be negative and must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
• Exclusion Criteria:
• • 1. Chemotherapy, targeted therapy, biological therapy, etc., had been used within 4 weeks or 5 half-lives before randomization, and palliative radiotherapy and modern traditional Chinese medicine preparations approved by NMPA had been used within 2 weeks;
• • 2. Patients with recurrent esophageal squamous cell carcinoma suitable for radical local treatment should be excluded;
• • 3. Frontline received ADCs with topoisomerase I inhibitors as toxins;
• • 4. History of severe heart disease and cerebrovascular disease;
• • 5. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• • 6. diagnosed with active malignancy within 3 years before randomization;
• • 7. Hypertension poorly controlled by two antihypertensive drugs;
• • 8. patients with poor glycemic control;
• • 9. present with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; A previous history of interstitial lung disease (ILD) or a suspicion of such disease on imaging during screening;
• • 10. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• • 11. patients with active central nervous system metastases;
• • 12. Severe infections within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
• • 13. patients with massive or symptomatic effusions or poorly controlled effusions;
• • 14. Imaging examination showed that the tumor had invaded or wrapped around the large blood vessels in the abdomen, chest, neck, and pharynx;
• • 15. serious unhealed wounds, ulcers, or fractures, or clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• • 16. patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction or chronic diarrhea;
• • 17. patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
• • 18. had a history of autologous or allogeneic stem cell transplantation;
• • 19. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
• • 20. a history of severe neurological or psychiatric illness;
• • 21. received other unmarketed investigational drugs or treatments within 4 weeks before randomization;
• • 22. subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;
• • 23. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.