A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 34
- Locations
- 8
- Primary Endpoint
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Study Overview
Brief Summary
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
- •Adequate coagulation, liver, and renal function.
- •Candidate for DCE-MRI evaluations.
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Exclusion Criteria
- •Evidence of significant bleeding problems.
- •History of certain gastrointestinal problems including fistula and abscess.
- •Chronic, uncontrolled hypertension.
- •Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Outcomes
Primary Outcomes
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time Frame: Baseline (Day 0) up to 30 days after last dose of study medication
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Secondary Outcomes
- Maximum Observed Serum Concentration (Cmax)(0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle))
- Serum Decay Half-Life (t1/2)(0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle))
- Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)](0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle))
- Apparent Volume of Distribution (Vss)(0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle))
- Time to Reach Maximum Observed Serum Concentration (Tmax)(0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle))
- Apparent Clearance (CL)(0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle))
- Recommended Phase 2 Dose (RP2D): Stage 1(Baseline (Day 0) up to 42 days after the last dose of study medication)
- Number of Participants With Anti-CVX-060 Antibodies(Baseline (Day 0) up to 42 days after last dose)
- Number of Samples From Participants With Anti-CVX-060 Antibodies(Baseline (Day 0) up to 42 days after last dose)
- Number of Participants With Best Overall Response (BOR)(Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133))