Actively Recruiting
A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors
Led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Updated on 2024-05-17
107
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.
CONDITIONS
Official Title
A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant 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) 250% within 28 days prior to first dose
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of 3 months or more
- During screening: Neutrophils 21.5 �D7 10^9/L, Platelets 210 �D7 10^9/L, Hemoglobin 290 g/L without recent transfusions or colony stimulating factors
- INR, PT, APTT 21.5 times upper limit of normal
- Serum total bilirubin 21.5 times upper limit of normal
- AST/ALT 23 times upper limit of normal or 25 times for liver metastasis
- Serum creatinine 21.5 times upper limit or creatinine clearance 260 mL/min
- Preferential subjects with measurable lesions in Part 1; subjects must have at least one measurable lesion in Part 2
- All acute toxicities from prior treatments resolved to baseline or grade 1 or less
- Fertile females or males with fertile female partners must agree to effective contraception from study start to 6 months after last treatment
- Female participants of childbearing potential must have negative pregnancy test within 7 days prior to enrollment
- Histologically or cytologically confirmed advanced or metastatic solid malignant tumors refractory or intolerant to standard treatment or no standard treatment available (Part 1)
- Pathologically confirmed advanced or metastatic breast cancer with HER2 overexpression failed prior HER2 targeted therapies (Cohort A, Part 2)
- Pathologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression failed two or more prior HER2 targeted therapies (Cohort B, Part 2)
You will not qualify if you...
- Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors
- Major surgery or severe trauma within 4 weeks before first dose
- Chemotherapy, targeted, anti-angiogenesis, biotherapy, immunotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before first dose
- Endocrine therapy within 3 weeks before first dose
- Autologous stem cell transplant within 3 months before first dose
- Other malignant tumors within past 3 years except cured non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, or other low malignant potential cancers effectively controlled without treatment
- Symptomatic central nervous system metastasis requiring glucocorticoids or progressive CNS metastasis
- Unresolved adverse reactions from previous anti-tumor treatments above grade 2 except alopecia or pigmentation or judged safe by investigator
- Clinically significant cardiovascular or cerebrovascular disease including symptomatic congestive heart failure (NYHA II-IV), serious arrhythmia, recent myocardial infarction or unstable angina within 6 months, QTc prolongation above 450 ms (males) or 470 ms (females)
- History of interstitial lung disease requiring glucocorticoids or suspected ILD on imaging
- Any uncontrolled active infection within 1 week prior to first dose
- Positive HIV antibody, active hepatitis B or C infection
- Concomitant diseases increasing toxicological risk
- Allergy to protein preparations or drugs similar to FDA022-BB05
- History of alcohol or psychotropic/narcotic drug abuse
- Pregnant or breastfeeding women
- Poor compliance or unsuitable for the study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
Research Team
X
Xinghe Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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