A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors
Summary
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.
Arms & interventions
- DrugEnzelkitug
Enzelkitug will be administered as per the schedule specified in the respective arms.
- DrugAtezolizumab
Atezolizumab will be administered as per the schedule specified in the respective arms.
- DrugPembrolizumab
Pembrolizumab will be administered as per the schedule specified in the respective arms.
Outcome measures
Primary
Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
Phase Ib: Number of Participants With DLTs
Time frame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 52 months
Phase Ib: Number of Participants With TEAEs
Time frame: Up to approximately 52 months
Secondary
Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug
Time frame: From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to each follow-up visits (up to approximately 52 months)
Phase Ia and Phase Ib: Objective Response Rate (ORR)
Time frame: From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
Phase Ia and Phase Ib: Duration of Response (DOR)
Time frame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
Phase Ia and Phase Ib: Progression-free Survival (PFS)
Time frame: From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
Phase Ia and Phase Ib: Percentage of Participants With Anti-drug Antibody (ADA) to Enzelkitug
Time frame: From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to treatment discontinuation (up to approximately 52 months)
Eligibility criteria
Study locations (11)
Stanford University
San Francisco, California, 94305
University Of Colorado
Aurora, Colorado, 80045
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
Winship Cancer Institute
Atlanta, Georgia, 30322
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Henry Ford Hospital
Detroit, Michigan, 48202
Washington University Medical Center, Division of Oncology
St Louis, Missouri, 63110
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
The West Clinic - Memphis (Union Ave)
Germantown, Tennessee, 38138
SCRI Oncology Partners
Nashville, Tennessee, 37203
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 98229