A Study in Patients With Advanced Cancers
- Summary
- A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
- Short title
- A Study in Patients With Advanced Cancers
- Official title
- A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2027-04-01
- First posted
- 2022-04-11
- Registry last updated
- 2022-07-19
- Primary completion date
- 2024-04-01
- Start date
- 2022-03-25
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- BiOneCure Therapeutics Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05320588
- ClinicalTrials.gov ID
- NCT05320588
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Timeframe: 1 year
Escalation period
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
Timeframe: up to 21 days
Escalation period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Timeframe: 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)
Timeframe: 2 years
Expansion 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 1)
Timeframe: 1 year
Escalation Period
Incidence of adverse event of special interest (AESI) - (Phase 2)
Timeframe: 2 years
Expansion period
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
Timeframe: 2 years
Expansion period
PK (Cmax) of BIO-106 - (Phase 1/2)
Timeframe: 2 years
Escalation and expansion periods
PK (AUC) of BIO-106 - (Phase 1/2)
Timeframe: 2 years
Escalation and expansion periods
Incidence of anti-BIO-106 antibodies - (Phase 1/2)
Timeframe: 2 years
Escalation and expansion periods
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
- 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:
- 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.
- NEXT Oncology AustinAustin, United StatesRecruiting
- University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
- NEXT Oncology VirginiaFairfax, United StatesRecruiting
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Metastatic malignant neoplasm Primary condition