Active, not recruiting
Non-small cell lung cancer, bladder cancer, head and neck cancer, hepatocellular cancer and others.
An immune checkpoint inhibitor is a drug that blocks certain proteins on cancer cells (PD-L1) or immune T cells (PD-1) that allow tumors to evade detection by the immune system.
Anti-PD-1 and anti-PD-L1 checkpoint inhibitors, including avelumab, atezolizumab, durvalumab, nivolumab, and pembrolizumab, are used to treat a variety of solid tumor cancers, including:
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Urothelial carcinoma
- Hepatocellular carcinoma
- Colorectal cancer
- Head and neck squamous cell carcinoma
- Gastric or gastroesophageal junction adenocarcinoma
- Merkel cell carcinoma
Clinical Trial Description:
This Phase 2, open-label study will evaluate the safety, tolerability, antitumor activity, and pharmacokinetics (PK) of adding eFT508 (tomivosertib) in subjects who have initiated anti-PD-1/anti-PD-L1 monotherapy and either developed progressive disease (PD) or have undergone 12 or more weeks of anti-PD-1/anti-PD-L1 therapy with no evidence of partial response (PR) or complete response (CR).
Subjects will continue their anti-PD-1/anti-PD-L1 therapy, and then add eFT508 (tomivosertib) prior to their next scheduled anti-PD-1/anti-PD-L1 therapy. The primary objectives of the trial are to evaluate the safety and antitumor activity of eFT508 (tomivosertib) when added to anti-PD-1/anti-Pd-L1 therapy.