Solid TumorPhase 1NCT06241898
A First-in-human of Multiplle Doses of BB-1709 in Subjects With Locally Advanced/Metastatic Solid Tumors
A Phase 1 study testing BB-1709 in people with Solid Tumor, run by Bliss Biopharmaceutical (Hangzhou) Co., Ltd at 1 site in China.
Trial summary
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 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-1709
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 30 Dec 2026
- 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.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors in patients who must have progressed on, be refractory to, or intolerant to prior SOC.
- At least one measurable lesion as defined per RECIST Version 1.1.
- Be able to provide archived or fresh tumor tissue specimens.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
Who cannot join
- Receiving anti-tumor therapy (systemic anti-tumor therapies, immunotherapy, biotherapy, topic therapy, other investigational product, radiation therapy, or surgery) within 4 weeks prior to the first dose of study treatment; receiving anti-tumor small-molecule agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study treatment; receiving anti-tumor Chinese traditional medication and herbal remedies within 2 weeks prior to the first dose of study treatment.
- Prior history of other malignancies within the previous 3 years, except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured.
- Major surgery or significant traumatic injury within 4 weeks before the first dose of study treatment or not fully recovered from surgery; or surgery planned during the study.
- Not recovered to baseline or CTCAE v5.0 ≤ grade 1 AEs from prior anti-cancer therapy except for alopecia, or asymptomatic and clinically not significant laboratory abnormalities.
- Grade 2 or greater peripheral neuropathy (PN) when signing ICF, or history of grade 3 neurotoxicity or PN, or history of treatment discontinuation due to neurotoxicity or PN.
- Active pneumonitis/interstitial lung disease (ILD), or history of radiotherapy to lung field within 12 months before the first dose of study treatment, or current lung disease with clinical symptoms(e.g., symptomatic chronic obstructive pulmonary disease or dyspnea)
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- Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases or leptomeningeal disease or carcinomatous meningitis requiring ongoing treatment for CNS metastases, including surgery or radiation therapy or steroids (>10 mg/day of prednisone or equivalent) and antiepileptic agents.
- Uncontrolled ascites, pleural effusion or pericardial effusion, as determined by the Investigator.
- Active autoimmune disease, except vitiligo or cured childhood asthma/allergies that requires no intervention after adulthood, autoimmune-mediated hypothyroidism treated with stable doses of thyroid hormone replacement, or Type I diabetes treated with stable doses of insulin can be excepted.
- History of organ transplantation (i.e., stem cell or solid organ transplant).
- Known history of human immunodeficiency virus (HIV) infection with the exception of patients with CD4+ T cell (CD4+) counts ≥350 cells/µL, or have not had a history of AIDS-defining opportunistic infections, or have not had a history of AIDS-defining opportunistic infections within the past 12 months , or on established antiretroviral therapy (ART) for more than four weeks and have an HIV viral load <400 copies/mL prior to enrollment.
- Active hepatitis B or hepatitis C infection, demonstrated by positive serology or requiring treatment. Subjects who are anti-HBs/HBcAb (+) without detectable HBV-DNA or are with undetectable HCV RNA are eligible. Subjects co-infected with hepatitis B and hepatitis C should be excluded.
- Any other serious underlying medical conditions, including but not limited to, uncontrolled diabetes mellitus, active uncontrolled infection (e.g. tuberculosis), active gastric ulcer, uncontrolled seizures, cerebrovascular incidents within 6 months prior to study treatment, gastrointestinal bleeding within 3 months prior to study treatment, severe signs and symptoms of coagulation and clotting disorders.
- Receipt of live vaccines within 4 weeks prior to the first dose of the study drug.
- Females who are pregnant or breastfeeding.
- History of severe hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in BB-1709 drug formulation.
- Concurrent condition that in the investigator's opinion would interfere with evaluation of the study drug or interpretation of subject safety or study results.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
LIN SHEN, doctor, 13911219511, doctorshenlin@sina.cn
About this study
Official title: A Phase I, Open Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1709 in Patients With Locally Advanced/Metastatic Solid Tumors
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
Read the detailed description
The study consists of two parts: dose-escalation (Phase Ia) and dose expansion (Phase Ib).
Phase Ia is a multicenter, open-label, first time in human clinical trial to assess safety, tolerability, pharmacokinetics, immunogenicity, the preliminary anti-tumor activity of BB-1709, and to establish the MTD and/or RP2D of BB-1709 in patients with advanced solid tumors.
Phase Ib is to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of BB-1709 in patients with specific types of solid tumor.
- Conditions
- Solid Tumor
- Being tested
- BB-1709
- Keywords
- ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-1709Drug
Subjects participating in Phase Ia study may continue to receive study treatment as long as they continue to show clinical benefit as judged by the investigator, until disease progression or intolerable toxicity, withdrawal of consent, death, or termination of the study.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | BB-1709 will be administered as an intravenous infusion by Q3W or Q2W as long as they continue to show clinical benefit as judged by the investigator, until disease progression or intolerable toxicity, withdrawal of consent, death, or termination of the study. Receives: Drug: BB-1709 |
| dose expansion | Experimental | BB-1709 will be administered as an intravenous infusion by Q3W or Q2W as long as they continue to show clinical benefit as judged by the investigator, until disease progression or intolerable toxicity, withdrawal of consent, death, or termination of the study. Receives: Drug: BB-1709 |
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-1709
Measured: up to 3 years
Secondary outcomes (1)
Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
To characterize the PK of BB-1709
Measured: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Oct 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (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
- 300 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
- NCT06241898
- Sponsor's protocol ID
- bliss
- Status last verified
- Sep 2025
- First submitted
- 28 Jan 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1709 in Patients With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06241898
- Acronym / sponsor ID
- bliss
- Conditions
- Solid Tumor
- Keywords
- ADC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bliss Biopharmaceutical (Hangzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Feb 2024 (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 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
Detailed description
The study consists of two parts: dose-escalation (Phase Ia) and dose expansion (Phase Ib).
Phase Ia is a multicenter, open-label, first time in human clinical trial to assess safety, tolerability, pharmacokinetics, immunogenicity, the preliminary anti-tumor activity of BB-1709, and to establish the MTD and/or RP2D of BB-1709 in patients with advanced solid tumors.
Phase Ib is to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of BB-1709 in patients with specific types of solid tumor.
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-1709BB-1709 will be administered as an intravenous infusion by Q3W or Q2W as long as they continue to show clinical benefit as judged by the investigator, until disease progression or intolerable toxicity, withdrawal of consent, death, or termination of the study. |
| dose expansion | Experimental | Drug: BB-1709BB-1709 will be administered as an intravenous infusion by Q3W or Q2W as long as they continue to show clinical benefit as judged by the investigator, until disease progression or intolerable toxicity, withdrawal of consent, death, or termination of the study. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent form (ICF) for the trial. Adult patients ≥ 18 years at the time of signing ICF.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors in patients who must have progressed on, be refractory to, or intolerant to prior SOC.
- At least one measurable lesion as defined per RECIST Version 1.1.
- Be able to provide archived or fresh tumor tissue specimens.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (18 listed)
- Receiving anti-tumor therapy (systemic anti-tumor therapies, immunotherapy, biotherapy, topic therapy, other investigational product, radiation therapy, or surgery) within 4 weeks prior to the first dose of study treatment; receiving anti-tumor small-molecule agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study treatment; receiving anti-tumor Chinese traditional medication and herbal remedies within 2 weeks prior to the first dose of study treatment.
- Prior history of other malignancies within the previous 3 years, except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured.
- Major surgery or significant traumatic injury within 4 weeks before the first dose of study treatment or not fully recovered from surgery; or surgery planned during the study.
- Not recovered to baseline or CTCAE v5.0 ≤ grade 1 AEs from prior anti-cancer therapy except for alopecia, or asymptomatic and clinically not significant laboratory abnormalities.
- Grade 2 or greater peripheral neuropathy (PN) when signing ICF, or history of grade 3 neurotoxicity or PN, or history of treatment discontinuation due to neurotoxicity or PN.
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-1709Subjects participating in Phase Ia study may continue to receive study treatment as long as they continue to show clinical benefit as judged by the investigator, until disease progression or intolerable toxicity, withdrawal of consent, death, or termination of the study. | Drug | dose escalation, dose expansion |
Primary outcome
Number of subjects with adverse events and serious adverse events
Time frame: up to 3 years
To evaluate the safety and tolerability of BB-1709
1 secondary outcome
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
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 26 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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-1709 in people with Solid Tumor, run by Bliss Biopharmaceutical (Hangzhou) Co., Ltd at 1 site 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 6 inclusion and 18 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 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 years). 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 26 Sep 2025.