A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Clinical and laboratory safety assessments
Overview
Brief Summary
The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to:
- find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely
- measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood
- determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing
Detailed Description
A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast Cancer
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Patients with HER2- Breast Cancer
Intervention: CNF2024 (Drug)
B
Patients with HER2+ Breast Cancer
Intervention: CNF2024 + trastuzumab (Drug)
Outcomes
Primary Outcomes
Clinical and laboratory safety assessments
Time Frame: 30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1
Secondary Outcomes
No secondary outcomes reported