Advanced CancerPhase 1/2NCT05320588
A Study in Patients With Advanced Cancers
A Phase 1/2 study testing BIO-106 and Pembrolizumab in people with Advanced Cancer and Advanced Solid Tumor, run by BiOneCure Therapeutics Inc. at 3 sites in United States.
Trial summary
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Advanced Solid Tumor, Cancer
- What is being tested?
- BIO-106 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Mar 2022to Apr 2027
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
- Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
- Measurable disease as determined by RECIST v.1.1 or bone only disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.
- Impaired cardiac function or history of clinically significant cardiac disease
- Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- Active SARS-CoV-2 infection.
- Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
NEXT Oncology Austin
Austin, Texas, 78758
Cynthia DeLeon, 210-580-9521, cdeleon@nextoncology.com
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Malaika Komtangi, 210-580-9500, mkomtangi@nextoncology.com
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Funda Meric-Bernstam, MD, 832-483-8248, fmeric@mdanderson.org
About this study
Official title: A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
Read the detailed description
This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of BIO-106 administered as monotherapy and in combination with pembrolizumab. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BIO-106 that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology
- Being tested
- BIO-106, Pembrolizumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO-106Drug
BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
PembrolizumabDrug
Also called Keytruda
Programmed death receptor-1 (PD 1)-blocking antibody
| Study group | Role | What they receive |
|---|---|---|
| Single agent BIO-106 | Experimental | Escalating doses followed by expansion targeting advanced cancers Receives: Drug: BIO-106 |
| Combination BIO-106 plus pembrolizumab | Experimental | Escalating doses followed by expansion targeting advanced cancers Receives: Drug: BIO-106; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Escalation period
Measured: 1 year
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
Escalation period
Measured: up to 21 days
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Escalation period
Measured: 1 year
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)
Expansion period
Measured: 2 years
Secondary outcomes (6)
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1)
Escalation Period
Measured: 1 year
Incidence of adverse event of special interest (AESI) - (Phase 2)
Expansion period
Measured: 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Expansion period
Measured: 2 years
PK (Cmax) of BIO-106 - (Phase 1/2)
Escalation and expansion periods
Measured: 2 years
PK (AUC) of BIO-106 - (Phase 1/2)
Escalation and expansion periods
Measured: 2 years
Incidence of anti-BIO-106 antibodies - (Phase 1/2)
Escalation and expansion periods
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start25 Mar 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Multiple ascending dose and dose-expansion of BIO-106 administered as a single agent or in combination with pembrolizumab.
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BiOneCure Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BiOneCure Clinical Development, Study director, BiOneCure Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320588
- Sponsor's protocol ID
- StarBridge-1
- Status last verified
- Jul 2022
- First submitted
- 2 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
- ClinicalTrials.gov ID
- NCT05320588
- Acronym / sponsor ID
- StarBridge-1
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- BiOneCure Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Apr 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.
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
Detailed description
This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of BIO-106 administered as monotherapy and in combination with pembrolizumab. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BIO-106 that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple ascending dose and dose-expansion of BIO-106 administered as a single agent or in combination with pembrolizumab.
| Arm | Type | Receives |
|---|---|---|
| Single agent BIO-106 | Experimental | Drug: BIO-106Escalating doses followed by expansion targeting advanced cancers |
| Combination BIO-106 plus pembrolizumab | Experimental | Drug: BIO-106, Drug: PembrolizumabEscalating doses followed by expansion targeting advanced cancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
- Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
- Measurable disease as determined by RECIST v.1.1 or bone only disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (6 listed)
- History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.
- Impaired cardiac function or history of clinically significant cardiac disease
- Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- Active SARS-CoV-2 infection.
- Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.
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 |
|---|---|---|
| BIO-106BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2) | Drug | Combination BIO-106 plus pembrolizumab, Single agent BIO-106 |
| PembrolizumabAlso: KeytrudaProgrammed death receptor-1 (PD 1)-blocking antibody | Drug | Combination BIO-106 plus pembrolizumab |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Time frame: 1 year
Escalation period
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
Time frame: up to 21 days
Escalation period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Time frame: 1 year
Escalation period
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)
Time frame: 2 years
Expansion period
6 secondary outcomes
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1)
Time frame: 1 year
Incidence of adverse event of special interest (AESI) - (Phase 2)
Time frame: 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Time frame: 2 years
PK (Cmax) of BIO-106 - (Phase 1/2)
Time frame: 2 years
PK (AUC) of BIO-106 - (Phase 1/2)
Time frame: 2 years
Incidence of anti-BIO-106 antibodies - (Phase 1/2)
Time frame: 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 19 Jul 2022.
- 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.
BiOneCure Clinical Development study director
BiOneCure Therapeutics Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BIO-106 and Pembrolizumab in people with Advanced Cancer and Advanced Solid Tumor, run by BiOneCure Therapeutics Inc. at 3 sites in United States.
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 4 inclusion and 6 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact BiOneCure Therapeutics Inc. ((240) 912-9101, Starbridge-1@bionecure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) (time frame: 1 year). The study lists 4 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 19 Jul 2022.