Safety Study of SEA-CD40 in Cancer Patients

Summary

This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Timeline

Start

2015-02-28

Primary completion

2023-03-06

Completion

2023-04-14

Outcome

Outcome not reported

Stopped (Business): “Study closed due to portfolio prioritization”

Publications

• Coveler AL, Smith DC, Phillips T, Curti BD, Goel S, Mehta AN, Kuzel TM, Markovic SN, Rixe O, Bajor DL, Gajewski TF, Gutierrez M, Lee HJ, Gopal AK, Caimi P, Heath EI, Thompson JA, Ansari S, Jacquemont C, Topletz-Erickson A, Zhou P, Schmitt MW, Grilley-Olson JE. Phase 1 dose-escalation study of SEA-CD40: a non-fucosylated CD40 agonist, in advanced solid tumors and lymphomas. J Immunother Cancer. 2023 Jun;11(6):e005584. doi: 10.1136/jitc-2022-005584.

Drugs

Indications