A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

Enzelkitug: Enzelkitug will be administered as per the schedule specified in the respective arms.

Atezolizumab: Atezolizumab will be administered as per the schedule specified in the respective arms.

Pembrolizumab: Pembrolizumab will be administered as per the schedule specified in the respective arms.

Study 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.

Eligibility

Primary outcome measure(s)

• Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs) — 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 — 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) — Up to approximately 52 months
• Phase Ib: Number of Participants With TEAEs — Up to approximately 52 months

Trial sites (36)