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Trial Title:
A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies
NCT ID:
NCT06131450
Condition:
Gynecological Malignancies
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
HER2 expression
Study type:
Interventional
Study phase:
Phase 1/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-M07D1
Description:
Administration by intravenous infusion
Arm group label:
BL-M07D1
Summary:
This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study
evaluating the efficacy and safety of BL-M07D1 for injection in patients with
HER2-expressing recurrent or metastatic gynecologic malignancies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Female;
3. Age: ≥18 years old and ≤75 years old;
4. Expected survival time ≥3 months;
5. patients with recurrent or metastatic HER2-positive/low-expression gynecologic
malignancies who have failed or are intolerant to standard treatment or who
currently have no standard treatment;
6. The histopathology of gynecological malignant tumors should meet the following
conditions: HER2 positive; Low expression of HER2;
7. Consent to provide archived tumor tissue samples or fresh tissue samples of primary
or metastatic lesions within 2 years;
8. At least one measurable lesion meeting the RECIST v1.1 definition was required;
9. ECOG score 0 or 1;
10. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by
NCI-CTCAE v5.0;
11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
12. No blood transfusion, use of any cell growth factors and/or platelet-raising drugs
were allowed within 14 days before screening, and the organ function level had to be
acceptable;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. albumin ≥30 g/L;
15. Women who are likely to give birth must have negative serum/urine pregnancy within 7
days before treatment and must be non-lactating; All enrolled patients should have
adequate contraception throughout the treatment cycle and for 6 months after the end
of treatment.
Exclusion Criteria:
1. had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas;
Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine
or Chinese patent medicine;
2. had received prior ADC drug therapy with camptothecin derivative (topoisomerase I
inhibitor) as toxin;
3. had a history of serious cardiovascular and cerebrovascular diseases;
4. active autoimmune or inflammatory diseases;
5. Patients with other malignant tumors within 5 years before the first administration,
except cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder
cancer and prostate/cervix/breast cancer in situ;
6. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and
pulmonary embolism requiring medical intervention within 6 months before screening;
7. patients with massive or symptomatic effusions or poorly controlled effusions;
8. Hypertension poorly controlled by antihypertensive drugs (systolic blood pressure
> 150 mmHg or diastolic blood pressure > 100 mmHg);
9. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation
pneumonitis requiring steroid therapy, or a history of these diseases;
10. patients with central nervous system (CNS) metastases and/or carcinomatous
meningitis (meningeal metastases);
11. patients with a history of allergy to recombinant humanized antibody or human-mouse
chimeric antibody or to any ingredient of BL-M07D1;
12. patients received previous organ transplantation or allogeneic hematopoietic stem
cell transplantation (Allo-HSCT);
13. HIVAb positive, active tuberculosis, active hepatitis B virus infection, or active
hepatitis C virus infection;
14. active infections requiring systemic therapy, such as severe pneumonia, bacteremia,
sepsis, etc.;
15. had participated in another clinical trial within 4 weeks before the first dose;
16. pregnant or lactating women;
17. The investigator did not consider it appropriate to apply other criteria for
participation in the trial.
Gender:
Female
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:
February 29, 2024
Completion date:
December 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/NCT06131450
