Actively Recruiting
A First-in-human of Multiplle Doses of BB-1709 in Subjects With Locally Advanced/Metastatic Solid Tumors
Led by Bliss Biopharmaceutical (Hangzhou) Co., Ltd · Updated on 2025-09-26
300
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test in patients with local advanced/metastatic solid tumors. the main questions it aims to answer are: * to assess the safety and tolerability of BB-1709. * to determine the maximum tolerated dose(MTD) and/or the PR2D of BB-1709
CONDITIONS
Official Title
A First-in-human of Multiplle Doses of BB-1709 in Subjects With Locally Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Aged 18 years or older at the time of consent.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors.
- Disease progressed on, refractory to, or intolerant to prior standard of care treatments.
- At least one measurable lesion per RECIST Version 1.1.
- Ability to provide archived or fresh tumor tissue samples.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of 12 weeks or more.
You will not qualify if you...
- Received anti-tumor therapy within 4 weeks prior to study treatment or anti-tumor small-molecule agents within 2 weeks or 5 half-lives before treatment.
- Used anti-tumor Chinese traditional medicine or herbal remedies within 2 weeks prior to study treatment.
- History of other cancers within the past 3 years except certain noninvasive malignancies.
- Major surgery or significant injury within 4 weeks before treatment or not fully recovered from surgery.
- Not recovered to baseline or mild adverse events from prior therapy except alopecia or clinically insignificant lab abnormalities.
- Grade 2 or higher peripheral neuropathy or history of severe neurotoxicity.
- Active pneumonitis, interstitial lung disease, recent lung radiotherapy, or symptomatic lung disease.
- Symptomatic or untreated brain metastases requiring ongoing treatment or steroids.
- Uncontrolled fluid buildup such as ascites, pleural or pericardial effusion.
- Active autoimmune disease except certain stable conditions.
- History of organ transplantation.
- Known HIV infection with exceptions for stable patients on treatment with controlled viral load.
- Active hepatitis B or C infection requiring treatment; co-infection excluded.
- Serious uncontrolled medical conditions including uncontrolled diabetes, infections, ulcers, seizures, recent strokes, gastrointestinal bleeding, or clotting disorders.
- Received live vaccines within 4 weeks prior to study treatment.
- Pregnant or breastfeeding females.
- History of severe allergies to protein drugs or components of BB-1709.
- Any condition that may interfere with study drug evaluation or safety interpretation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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