NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
Tumor, Colorectal Cancer
About this trial
This is an interventional treatment trial for Tumor focused on measuring Phase 2a: Multiple solid tumor types, Phase 2b: Second-Line Colorectal Cancer (CRC)
Eligibility Criteria
Inclusion Criteria:
- Male and non-pregnant, non-lactating female patients with an ECOG performance score <3 who have any type of solid tumor refractory to standard therapy and who have adequate bone marrow and organ function at screening.
Exclusion Criteria:
- Patients must not have used any CYP3A4 inducers or inhibitors with 2 weeks prior to the first day of study drug treatment.
Sites / Locations
- Investigator Site - Scottsdale
- Investigator Site - Louisville
- Investigator Site - Dallas
- Investigator Site - Tyler
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
NKTR-102 100 mg/m2 + Cetuximab
NKTR-102 125 mg/m2 + Cetuximab
NKTR-102 100 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.
NKTR-102 125 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.