Actively Recruiting

Phase 1
Age: 18Years - 78Years
All Genders
NCT05217693

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

Age: 18Years - 78Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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