Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer

This is a Phase Ib/2 study of retaspimycin HCl (IPI-504) in combination with everolimus. The
Phase 1b portion is to test the safety and tolerability of retaspimycin HCl (IPI-504) in
combination with everolimus and determine the highest dose of retaspimycin HCl (IPI-504) and
everolimus that can safely be given in combination. The Phase 2 portion of this study will
continue the evaluation of safety of retaspimycin HCl (IPI-504) in combination with
everolimus and compare the effect of the study drugs on tumor response and life expectancy
in patients with KRAS mutant NSCLC.

Inclusion Criteria:

1. ≥18 years of age

2. Voluntarily sign an informed consent form (ICF).

3. Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV

4. Archival NSCLC tissue available to provide for analysis or have a lesion that is
accessible for biopsy

5. Experienced disease progression during or after receiving at least 1 prior
platinum-containing chemotherapy regimen.

6. ECOG performance of 0-1.

Exclusion Criteria:

1. Prior treatment with IPI-504 or other Hsp90 inhibitors.

2. Prior treatment with everolimus, other rapamycin analogs, AP23573(Ridaforolimus),
rapamycin, or other mTOR inhibitors.

3. Has not recovered from any toxicities related to prior treatment (to Grade 1 or
baseline), excluding alopecia.

4. Inadequate hematologic function defined as:

5. Inadequate hepatic function defined by:

6. Inadequate renal function defined by serum creatinine >1.5 x ULN.