Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

This is a multicenter, open-label, single-arm Phase 2 study of the SINE selinexor given
orally to patients diagnosed with advanced SCC of the head and neck, lung, or esophagus who
have experienced relapse and/or metastasis following multiple prior chemotherapy treatments
(<2 lines of therapy).

Patients will receive fixed doses of selinexor tablets twice weekly in 28-day cycles.
Patients may continue from one cycle to the next without interruption as along as all
criteria are met and no reason for discontinuation occurs.

Inclusion Criteria:

- 18 years of age or older

- confirmed SCC of the head and neck, lung, or esophagus

- 1 to 2 prior therapies

- measurable disease at screening and documented progression within the past 6 weeks

Exclusion Criteria:

- patients requiring total parenteral nutrition

- unstable cardiovascular function

- substantially impaired gastrointestinal function

- Symptomatic brain metastases

- another malignancy within 3 years except adequately treated in situ carcinoma of any
type, basal or non-melanomatous skin cancer