Safety and Tolerability of CVHNLC Plus Pembrolizumab in Patients With Squamous Non Small-Cell Lung Cancer (sqNSCLC)
Summary
This is an open-label, first-in-human, dose escalation study of CV09070101 mRNA (CVHNLC) in patients with metastatic Squamous Non-Small-Cell Lung Cancer (sqNSCLC). The study will evaluate the safety and tolerability of CVHNLC plus pembrolizumab in an Dose Escalation Part and, once the safety of this combination is established, CVHNLC plus prembrolizumab and chemotherapy (carboplatin and paclitaxel) will be evaluated in an Dose Expansion Part with the recommended dose selected from the Dose Escalation Part.
Timeline
- Start
- 2025-07-30
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
Outcome
Outcome not reported
Stopped (Business): “In accordance with 21 CFR 312.38, CureVac is herewith withdrawing IND No. 031346 for CV09070101 (referred to as CVHNLC) for the indication of squamous Non-Small-Cell Lung Cancer (sqNSCLC), following the strategic decision to not pursue the CVHNL”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CV09070101 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | CV09070101 | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | CV09070101 | Messenger RNA (mRNA) | 200 ug | Intramuscular |
| Subject | CV09070101 | Messenger RNA (mRNA) | 400 ug | Intramuscular |