Neoplasms
Conditions
Brief summary
The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies
Interventions
DRUGBMS-844203 (CT-322)
Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group performance 0-1
Exclusion criteria
* Subject has uncontrolled diabetes or hypertension * Clinical significant bleeding diathesis or coagulopathy * Thrombotic or embolic cerebrovascular accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine recommended dose for Phase 2 study of CT-322 | Within the first 28 days |
Secondary
| Measure | Time frame |
|---|---|
| To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc. | Cycle 1: Day 1 to 5, 8, 15, 22 to 26 and 29 |
| To assess anti-tumor activity of CT-322 | Every 8 weeks |
| To assess the effects of CT-322 on plasma VEGF levels | Cycle 1: Day 1, 3, 8, 15, 22 |
| To assess the presence of anti CT-322 antibodies | Cycle 1: Day 1, 15, 22 and 29 |
Countries
Japan
Outcome results
None listed