A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid Tumors

NCT05217693 | Recruiting Phase 1 DMC

• 1 other identifier: BB-1705-101
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 7

Brief Summary

The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II).

Conditions

Solid Tumor

Keywords

ADC

Outcome Measures

Primary Outcomes (3)

• Number of subjects with adverse events and serious adverse events

  To evaluate the safety and tolerability of BB-1705

  up to 2 years

• Number of subjects with dose limiting toxicity (DLT)

  Subjects are evaluated for all study drug related and treatment emergent toxicities based on the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE)

  Cycle 1. Duration of each cycle is 21 days.

• MTD

  MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycle.

  Cycle 1. Duration of each cycle is 21 days.

Secondary Outcomes (6)

• Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf)

  Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.

• Maximum observed plasma concentration (Cmax)

  Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.

• Incidence of anti-drug antibodies

  Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 4, 6, and 8. Duration of each cycle is 21 days.

• Objective response

  Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)

• Progression Free Survival

  Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)

Study Arms (2)

dose escalation

EXPERIMENTAL

Drug: BB-1705 BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles

Drug: BB-1705

cohort expansion

EXPERIMENTAL

BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles

Drug: BB-1705

Interventions

BB-1705 DRUG

BB-1705 is an ADC consisting of an engineered humanized IgG1κ monoclonal antibody conjugated to the cytotoxic agent eribulin via a cathepsin-cleavable valine-citrulline linker. BB-1705 has a molecular weight of approximately 152 kDa, including two molecules of eribulin via the linker.

cohort expansion; dose escalation

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent form (ICF) for the trial.
• Adult patients ≥ 18 years at the time of signing ICF.
• Patient must have a histologically or cytologically confirmed, locally advanced, unresectable, or metastatic solid tumors:
• At least one measurable lesion as defined per RECIST Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥12 weeks.
• Adequate organ function as indicated by the following laboratory values (had not received blood transfusion, EPO, G-CSF, or other medical support within the 14 days before the administration of BB-1705):
• Women of childbearing potential and males with fertile female partner must be willing to use currently accepted reliable contraception method throughout the treatment period from ICF signed and for at least 6 months following the last dose of BB-1705. These measures include, but are not limited to, oral or implantable injections of hormonal contraceptives; intrauterine birth control ring or placement of IUS intrauterine device); or use of barrier methods such as condoms or septum and spermicide products. Postmenopausal women over 50 years of age must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of investigational product.

You may not qualify if:

• Receiving cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment
• Prior history of other malignancies.
• Not recovered to baseline or ≤ grade 1 adverse events from prior anti-cancer treatment.
• Major surgery within 4 weeks and minor surgery within 2 weeks before the first dose or not fully recovered from surgery; or surgery planned during the time the patient is expected to participate in the study
• Grade 2 or higher peripheral neuropathy.
• Active pneumonitis/interstitial lung disease (ILD), a history of pneumonitis/ILD that required systemic steroids, received radiotherapy to lung field within 12 months before the first dose of study intervention, or current clinically relevant-lung disease
• Symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases, including steroids (\>10 mg of prednisone or 4 mg of dexamethasone) and antiepileptic agents.
• Any other serious ongoing underlying medical conditions, including but not limited to, uncontrolled diabetes mellitus, active uncontrolled infection, vaccination within 4 weeks, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents within 6 months of study entry, gastrointestinal bleeding within 3 months of study entry, severe signs and symptoms of coagulation and clotting disorders.
• QTc interval ≥450 ms for male or ≥470 ms for female (Fridericia's formula) and patients with congenital long QT syndrome.

Sponsors & Collaborators

• Bliss Biopharmaceutical (Hangzhou) Co., Ltd: lead

Study Sites (7)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Hunan Cancer Hospital

Changsha, China

RECRUITING

First affiliated hospital of Gannan medical university

Ganzhou, China

RECRUITING

Bliss Biopharmaceutical Co, Ltd

Hangzhou, China

RECRUITING

Zhejiang University School of Medicine - The First Affiliated Hospital

Hanzhou, China

RECRUITING

Linyi Cancer Hospital

Linyi, China

RECRUITING

Jiangsu Province Hospital

Nanjing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 1, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)