Trials / Recruiting
RecruitingNCT05320588
A Study in Patients With Advanced Cancers
A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 332 (estimated)
- Sponsor
- BiOneCure Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIO-106 | BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2) |
| DRUG | Pembrolizumab | Programmed death receptor-1 (PD 1)-blocking antibody |
Timeline
- Start date
- 2022-03-25
- Primary completion
- 2024-04-01
- Completion
- 2027-04-01
- First posted
- 2022-04-11
- Last updated
- 2022-07-19
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05320588. Inclusion in this directory is not an endorsement.