Solid TumorPhase 1NCT05217693
A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid Tumors
A Phase 1 study testing BB-1705 in people with Solid Tumor, run by Bliss Biopharmaceutical (Hangzhou) Co., Ltd at 7 sites in China.
Trial summary
The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II). Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BB-1705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jun 2022to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
SHEN LIN, 13911219511, doctorshenlin@sina.cn
- Recruiting
Hunan Cancer Hospital
Changsha
LIN JINGUAN, 13307318568, linjingguan@hnca.org.cn
- Recruiting
First affiliated hospital of Gannan medical university
Ganzhou
SHI HUAQIU, 13576666365, shq3677274@163.com
- Recruiting
Bliss Biopharmaceutical Co, Ltd
Hangzhou
Tang Huoling, 17301835287, yyang@blissbiopharma.com
- Recruiting
Zhejiang University School of Medicine - The First Affiliated Hospital
Hanzhou
ZHENG YULONG, 13588166206, zn_loogen@126.com
- Recruiting
Linyi Cancer Hospital
Linyi
SHI JIANGHUA, 15963998868, shijianhualy@126.com
- Recruiting
Jiangsu Province Hospital
Nanjing
GUAN XIANGXIAN, 13512510329, xguan@njmu.edu.cn
About this study
Official title: A Phase I First-in-human, Open Label, Multicenter, Dose Escalation and Cohort Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1705 in Patients With Locally Advanced/Metastatic Solid Tumors
The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II).
Read the detailed description
Phase Ia is a dose escalation study to assess the safety and tolerability, and to determine the MTD or MAD and RP2D of BB-1705.
Phase Ib is a cohort expansion study to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Patients with locally advanced and unresectable or metastatic solid tumors who have progressed on prior lines of standard of care therapies will be enrolled in this study if eligible.
- Conditions
- Solid Tumor
- Being tested
- BB-1705
- Keywords
- ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-1705Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | Drug: BB-1705 BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles Receives: Drug: BB-1705 |
| cohort expansion | Experimental | BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles Receives: Drug: BB-1705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and serious adverse events
To evaluate the safety and tolerability of BB-1705
Measured: 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)
Measured: 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.
Measured: 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)
To characterize the PK of BB-1705
Measured: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.
Maximum observed plasma concentration (Cmax)
To characterize the PK of BB-1705
Measured: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.
Incidence of anti-drug antibodies
To assess the immunogenicity of BB-1705
Measured: 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
To assess the preliminary anti-tumor activity of BB-1705
Measured: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)
Progression Free Survival
To assess the preliminary anti-tumor activity of BB-1705
Measured: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)
Duration of Response
To assess the preliminary anti-tumor activity of BB-1705
Measured: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bliss Biopharmaceutical (Hangzhou) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217693
- Sponsor's protocol ID
- BB-1705-101
- Status last verified
- Jul 2025
- First submitted
- 29 Dec 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I First-in-human, Open Label, Multicenter, Dose Escalation and Cohort Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1705 in Patients With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05217693
- Acronym / sponsor ID
- BB-1705-101
- Conditions
- Solid Tumor
- Keywords
- ADC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Bliss Biopharmaceutical (Hangzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II).
Detailed description
Phase Ia is a dose escalation study to assess the safety and tolerability, and to determine the MTD or MAD and RP2D of BB-1705.
Phase Ib is a cohort expansion study to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Patients with locally advanced and unresectable or metastatic solid tumors who have progressed on prior lines of standard of care therapies will be enrolled in this study if eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Drug: BB-1705Drug: BB-1705 BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles |
| cohort expansion | Experimental | Drug: BB-1705BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB-1705BB-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. | Drug | cohort expansion, dose escalation |
Primary outcome
Number of subjects with adverse events and serious adverse events
Time frame: up to 2 years
To evaluate the safety and tolerability of BB-1705
Number of subjects with dose limiting toxicity (DLT)
Time frame: Cycle 1. Duration of each cycle is 21 days.
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)
MTD
Time frame: Cycle 1. Duration of each cycle is 21 days.
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.
6 secondary outcomes
Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.
Incidence of anti-drug antibodies
Time frame: 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
Time frame: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)
Progression Free Survival
Time frame: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)
Duration of Response
Time frame: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BB-1705 in people with Solid Tumor, run by Bliss Biopharmaceutical (Hangzhou) Co., Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events and serious adverse events (time frame: up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.