Actively Recruiting
A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid Tumors
Led by Bliss Biopharmaceutical (Hangzhou) Co., Ltd · Updated on 2025-07-24
288
Participants Needed
7
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II).
CONDITIONS
Official Title
A First-in-human of Multiplle Doses of BB-1705 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
- Adults aged 18 years or older at the time of consent
- Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumors
- At least one measurable tumor lesion according to RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function as shown by laboratory values, with no recent blood transfusions or certain supportive treatments within 14 days before BB-1705 administration
- Women of childbearing potential and males with fertile female partners must agree to use reliable contraception throughout treatment and for at least 6 months after last dose
- Women over 50 years old must be postmenopausal for at least 12 months
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
You will not qualify if you...
- Receiving cancer therapy (chemotherapy, systemic therapy, immunotherapy, radiation, or surgery) at enrollment
- History of other malignancies
- Not recovered to baseline or grade 1 or lower from prior anti-cancer treatment adverse events
- Major surgery within 4 weeks or minor surgery within 2 weeks before first dose, or surgery planned during study participation
- Grade 2 or higher peripheral neuropathy
- Active pneumonitis, interstitial lung disease, or recent lung radiotherapy within 12 months
- Symptomatic or untreated central nervous system metastases or ongoing treatment requiring steroids or antiepileptics
- Serious ongoing medical conditions such as uncontrolled diabetes, infection, recent vaccination, active gastric ulcer, seizures, recent cerebrovascular incidents, gastrointestinal bleeding, or severe clotting disorders
- QTc interval over 450 ms for males or 470 ms for females, or congenital long QT syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
3
First affiliated hospital of Gannan medical university
Ganzhou, China
Actively Recruiting
4
Bliss Biopharmaceutical Co, Ltd
Hangzhou, China
Actively Recruiting
5
Zhejiang University School of Medicine - The First Affiliated Hospital
Hanzhou, China
Actively Recruiting
6
Linyi Cancer Hospital
Linyi, China
Actively Recruiting
7
Jiangsu Province Hospital
Nanjing, 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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