Trials / Recruiting
RecruitingNCT05581004
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
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Locally Advanced or Metastatic Solid Tumors
- NSCLC
- HNSCC
- Melanoma
- TNBC
- Esophageal Cancer
- Gastric Cancer
- Cervical Cancer
- Colorectal Cancer
- Urothelial Carcinoma
- Clear Cell RCC
- HCC
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzelkitug | Enzelkitug will be administered as per the schedule specified in the respective arms. |
| DRUG | Atezolizumab | Atezolizumab will be administered as per the schedule specified in the respective arms. |
| DRUG | Pembrolizumab | Pembrolizumab will be administered as per the schedule specified in the respective arms. |
Timeline
- Start date
- 2022-10-20
- Primary completion
- 2028-07-31
- Completion
- 2028-07-31
- First posted
- 2022-10-14
- Last updated
- 2026-04-15
Locations
41 sites across 10 countries: United States, Australia, Belgium, Canada, Greece, Netherlands, South Korea, Spain, Sweden, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05581004. Inclusion in this directory is not an endorsement.