Actively Recruiting
A Study of Bio-008 in Subjects With Advanced or Metastatic Solid Tumours
Led by Shijiazhuang Yiling Pharmaceutical Co. Ltd · Updated on 2023-09-07
60
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1: Dose escalation study (Phase Ia) Main purpose: Evaluate the safety and tolerability of BIO-008 in patients with advanced solid tumors, and determine the maximum tolerable dose (MTD) and dose limiting toxicity (DLT) of BIO-008. Secondary purpose: Evaluate the pharmacokinetic (PK) characteristics of BIO-008; Evaluate the immunogenicity of BIO-008. Exploratory purposes: Preliminary evaluation of the anti-tumor activity of BIO-008 (if available); Detect the expression of CLDN18.2 in tumor tissue and explore its correlation with BIO-008 anti-tumor activity indicators (only applicable to subjects who can provide fresh or archived tumor tissue samples before the first administration). Phase 2: Dose Extension Study (Phase Ib) Main purpose: • Preliminary evaluation of ORR of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer (GC/GEJ), pancreatic cancer (PC) and other solid tumors; Determine the recommended dose for clinical phase II (RP2D). Secondary purpose: Evaluate the safety and tolerability of BIO-008; Evaluate the PK characteristics of BIO-008; Evaluate the immunogenicity of BIO-008; • Evaluate other anti-tumor activity indicators of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer, pancreatic cancer and other solid tumors; Evaluate the correlation between the anti-tumor activity of BIO-008 and the expression of CLDN18.2.
CONDITIONS
Official Title
A Study of Bio-008 in Subjects With Advanced or Metastatic Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreement to follow the study protocol
- Age between 18 and 75 years old
- Diagnosed with advanced solid tumors with confirmed failure or intolerance of standard therapy, or no standard therapy available
- For Phase Ia, agreement to provide fresh or archived tumor tissue samples before first dose; positive CLDN18.2 expression not required
- For Phase Ib, positive CLDN18.2 expression confirmed by central laboratory and agreement to provide tumor tissue samples
- At least evaluable lesions (Phase Ia) or at least one measurable lesion (Phase Ib) according to RECIST v1.1
- ECOG performance status of 0 or 1
- Estimated survival time of at least 3 months
- Recovery to grade 1 toxicity or better from previous anti-tumor therapy as defined by CTCAE v5.0, with exceptions for certain non-safety risks
- Adequate bone marrow, coagulation, liver, and renal function within 7 days before first dose
- Agreement to use reliable contraception during the study and for 6 months after last dose if of childbearing potential
- Negative pregnancy test for women of childbearing age within 7 days before first dose
You will not qualify if you...
- Allergy or hypersensitivity to similar products or excipients
- Receipt of other clinical trial drugs or treatments within 28 days prior to first dose
- Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 28 days prior to first dose, with exceptions judged by investigator
- Prior treatment with antitumor drugs targeting CLDN18.2
- Vaccination with any live vaccine within 28 days prior to first dose
- Use of immunosuppressants or systemic corticosteroids above specified doses within 14 days prior to first dose
- Major organ surgery, significant trauma, or interventional therapy within 28 days prior to first dose
- Use of anticoagulants except for prophylactic doses
- Gastrointestinal obstruction, recurrent vomiting, uncontrolled bleeding or ulcers within 28 days prior to first dose
- Active infection within 1 week prior to first dose requiring treatment
- Uncontrolled central nervous system or meningeal metastases
- Poorly controlled pleural, pericardial effusion, or ascites requiring repeated drainage
- History of interstitial lung disease, pulmonary fibrosis, or drug-induced lung disease
- Severe cardiovascular or cerebrovascular diseases as specified
- Second primary tumor within 5 years except certain skin cancers
- History of immunodeficiency, organ transplantation, or active autoimmune/inflammatory diseases
- Active HIV, HBV, HCV, or syphilis infection
- History of substance abuse
- Mental illness or poor compliance
- Inability to tolerate venous blood collection
- Pregnancy or lactation
- Other serious systemic diseases or conditions judged by investigator as unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of the Chinese People's Liberation Army Air Force Military Medical University
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
W
wei Wang, master
CONTACT
J
jie Zhou, PM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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