Tests two cancer drugs alone and together in cervical cancer that returned or spread
Tests two experimental drugs, alone and combined, in cervical cancer that spread.
Plain-language title generated from the registry record
Registry title: A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 75 with cervical cancer or another gynecological cancer that has come back or spread, after standard treatment failed or was not tolerated, or when no standard treatment exists.
- Age
- 18 to 75 years
- Sex
- Women only
- Disease stage
- Recurrent or metastatic cervical cancer or other gynecological cancer, confirmed by tissue and/or cell tests. At least one measurable tumor is needed. Expected survival of at least 3 months. ECOG score 0-1.
- Earlier treatment
- Standard treatment must have failed or not been tolerated, or no standard treatment is available. Side effects of earlier cancer treatment must have settled to grade 1 or milder. Earlier treatment with an ADC drug that uses a topoisomerase I inhibitor as its toxin is not allowed.
- Biomarker or test result
- Not stated. Participants must agree to give tumor tissue samples (surgical or fresh) taken within 3 years.
Main reasons for not taking part
- Serious heart, blood vessel or brain vessel disease in the past
- Past or current interstitial lung disease (ILD)
- Active brain or spinal cord (central nervous system) metastases
- Organ transplant or allogeneic stem cell transplant in the past
- HIV antibody positive, active tuberculosis, or active hepatitis B or C infection
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05990803, who can take part
Where in China
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT05990803
- Record updated
- 26 September 2025
- Original description
Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.Read full original descriptionShow less
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.
Inclusion: Subject volunteered to participate in the study and signed an informed consent; Women aged ≥18 years and ≤75 years; Expected survival time ≥3 months; ECOG score 0-1; Gynecological malignancies such as recurrent or metastatic cervical cancer confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which no standard treatment is available; Agree to provide 10 surgical specimens or fresh tissue samples of primary or metastatic tumors within 3 years; At least one measurable lesion meeting the RECIST v1.1 definition was required; No blood transfusion, colony-stimulating factor, any cell growth factor injection, or albumin injection were allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements; Urine protein ≤2+ or ≤1000g/24h; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient 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: Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin; Use of antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil or palliative radiotherapy within 2 weeks before the first dose; Cohort_B, Cohort_C, who had received an immunomodulatory drug within 14 days before the first dose of study drug; New onset of deep vein thrombosis within 14 days before screening or pulmonary embolism within 6 months; Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; Had participated in another clinical trial within 4 weeks before the first dose; Patients with a history of intestinal obstruction within 6 months before the screening period; Cohort_B and Cohort_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis; Had a history of serious cardiovascular and cerebrovascular diseases; Active autoimmune and inflammatory diseases; Other malignant tumors that progressed or required treatment within 5 years before the first dose; A history of ILD requiring steroid therapy, current ILD, or suspected ILD at screening that could not be ruled out by imaging; History of poorly controlled diabetes mellitus, poorly controlled hypertension, or hypertensive crisis or hypertensive encephalopathy before the first medication; Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients; Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection; Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc; Who have a history of psychotropic drug abuse and cannot quit or have mental disorders; Patients with active central nervous system metastases; Patients with massive, symptomatic, poorly controlled, or unstable effusions; Other circumstances that the investigator deemed inappropriate for participation in the trial.