Actively Recruiting
A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors
Led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Updated on 2024-09-26
150
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.
CONDITIONS
Official Title
A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Left Ventricular Ejection Fraction (LVEF) 50% within 28 days prior to first dose.
- Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.
- Life expectancy 3 months.
- Histopathologically or cytologically confirmed advanced/unresectable or metastatic solid malignant tumors refractory or intolerable to standard treatment, or no standard treatment available.
- Cohort A: Breast cancer that is unresectable or metastatic, with low HER2 expression (IHC 2+/ISH- or IHC 1+), refractory to endocrine therapy if HR-positive, and never previously HER2-positive.
- Cohort B: Endometrial cancer that is unresectable or metastatic, with HER2 expression (1+, 2+, or 3+), prior platinum-based therapy, and no previous ADC anti-tumor treatment.
- Cohort C: Metastatic or advanced solid tumors with HER2 overexpression or mutation including urothelial cancer, colorectal adenocarcinoma, and non-small cell lung cancer.
You will not qualify if you...
- Prior treatment with antibody-drug conjugate containing topoisomerase I inhibitors.
- Major operation or severe trauma within 4 weeks prior to first dose.
- Chemotherapy, targeted therapy, anti-angiogenesis therapy, biotherapy, immunotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks.
- Endocrine therapy within 3 weeks.
- Autologous stem cell transplant within 3 months.
- Other malignant tumors in the past three years except certain low-risk cancers effectively controlled without treatment.
- Symptomatic central nervous system metastasis requiring glucocorticoids or progressive CNS metastasis.
- Unrecovered adverse reactions from previous anti-tumor treatment greater than Grade 2 except alopecia and pigmentation.
- Clinically significant cardiovascular or cerebrovascular disease including symptomatic congestive heart failure (NYHA II-IV), serious arrhythmia, myocardial infarction or unstable angina within 6 months, or QTc prolongation over defined limits.
- History of interstitial lung disease or pneumonia needing glucocorticoids, or suspicious ILD on imaging.
- Uncontrolled active infection within 1 week prior to first dose.
- Concomitant diseases increasing toxicological risk or allergy to protein drugs similar to FDA022-BB05.
- History of alcohol abuse or psychotropic/narcotic drug abuse.
- Pregnant or lactating women.
- Poor compliance or unsuitable for study as determined by investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
J
Jian Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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