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Trial 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
NCT ID:
NCT05990803
Condition:
Cervical Cancer
Conditions: Official terms:
Neoplasms
Uterine Cervical Neoplasms
Conditions: Keywords:
Gynecological malignancies
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
SI-B003
Description:
SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).
Arm group label:
Study treatment
Summary:
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.
Detailed description:
Objective: To explore the efficacy of BL-B01D1 monotherapy, SI-B003 monotherapy, and
BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical
cancer. To explore the safety and tolerability of BL-B01D1 monotherapy, SI-B003
monotherapy and BL-B01D1+SI-B003 combination therapy in patients with recurrent or
metastatic cervical cancer and other gynecological malignancies, and to further explore
the optimal dose and mode of combination therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject volunteered to participate in the study and signed an informed consent;
2. Women aged ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG score 0-1;
5. 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;
6. Agree to provide 10 surgical specimens or fresh tissue samples of primary or
metastatic tumors within 3 years;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. 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;
9. Urine protein ≤2+ or ≤1000g/24h;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
12. 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 Criteria:
1. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
2. 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;
3. Cohort_B and Cohort_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2
immune-related myocarditis;
4. Cohort_B, Cohort_C, who had received an immunomodulatory drug within 14 days before
the first dose of study drug;
5. Had a history of serious cardiovascular and cerebrovascular diseases;
6. Active autoimmune and inflammatory diseases;
7. Other malignant tumors that progressed or required treatment within 5 years before
the first dose;
8. A history of ILD requiring steroid therapy, current ILD, or suspected ILD at
screening that could not be ruled out by imaging;
9. History of poorly controlled diabetes mellitus, poorly controlled hypertension, or
hypertensive crisis or hypertensive encephalopathy before the first medication;
10. New onset of deep vein thrombosis within 14 days before screening or pulmonary
embolism within 6 months;
11. Patients with active central nervous system metastases;
12. Patients with massive, symptomatic, poorly controlled, or unstable effusions;
13. Patients with a history of allergy to recombinant humanized antibody or human-mouse
chimeric antibody or to any of BL-B01D1's excipients;
14. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
15. Human immunodeficiency virus antibody positive, active tuberculosis, active
hepatitis B virus infection or active hepatitis C virus infection;
16. Active infections requiring systemic therapy, such as severe pneumonia, bacteremia,
sepsis, etc;
17. Had participated in another clinical trial within 4 weeks before the first dose;
18. Who have a history of psychotropic drug abuse and cannot quit or have mental
disorders;
19. Patients with a history of intestinal obstruction within 6 months before the
screening period;
20. Other circumstances that the investigator deemed inappropriate for participation in
the trial.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lingying Wu
Start date:
November 6, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05990803
