Actively Recruiting
A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors
Led by Bio-Thera Solutions · Updated on 2025-08-13
216
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study.
CONDITIONS
Official Title
A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female, and willing to provide informed consent
- Estimated survival of at least 3 months as judged by investigators
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- For dose escalation: Patients with HER-2 expression confirmed by histopathology or cytopathology (IHC3+, IHC2+/FISH+, or IHC2+/FISH-) who have failed standard therapy, lack standard options, or are unsuitable for standard therapy; tumor types include but are not limited to breast, stomach, non-small cell lung, biliary tract, colorectal, and urothelial carcinoma
- For dose expansion: Patients divided into cohorts with breast cancer, urothelial carcinoma, or gastric adenocarcinoma with HER-2 expression and prior failure or unsuitability of standard treatments
- Dose escalation patients must have evaluable tumor lesions; dose expansion patients must have at least one measurable tumor lesion per RECIST 1.1
- Negative pregnancy test during screening, before first dose, and on first day of each cycle; agreement to use effective contraception during study and for 90 days after last dose; no egg donation
You will not qualify if you...
- Prior treatment with HER2-targeted drugs causing grade 3 adverse events related to treatment or unknown cause, or left ventricular ejection fraction below 50%
- Previous doxorubicin use with cumulative dose over 360 mg/m2 or equivalent anthracyclines
- Grade 1 or higher adverse events from prior antitumor therapy before investigational drug, except hair loss, pigmentation, or stable distal toxicity
- Primary central nervous system tumor, symptomatic CNS metastasis, meningeal metastasis, or epilepsy history; stable asymptomatic CNS metastases allowed under conditions
- Major surgery within 28 days before first investigational drug dose or unresolved postoperative complications after 21 days
- Severe infection within 4 weeks before dosing or active infection symptoms within 2 weeks before dosing
- Untreated or active tuberculosis, immunodeficiency including HIV, or history of organ transplantation
- Active hepatitis B or C infection or positive tests for syphilis
- Symptomatic congestive heart failure (NYHA II-IV), severe arrhythmias needing treatment, recent myocardial infarction or unstable angina except atrial fibrillation or paroxysmal supraventricular tachycardia
- History of non-infectious pneumonia requiring steroids or current interstitial lung disease
- Serious underlying medical conditions or psychiatric/family factors affecting treatment compliance or safety
- Less than 28 days since last anti-tumor therapy, except for certain allowed therapies; insufficient recovery from radiotherapy side effects
- Therapeutic radiopharmaceutical use within 8 weeks before first dose
- Known allergy or intolerance to study drugs or excipients
- Pregnant or lactating women
- Considered unsuitable for participation by investigator for any reason
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
Xizhen Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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