Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors

Inclusion Criteria:

- Must have evidence of c-MET dysregulation from either local data or the results of
molecular pre-screening evaluations.

- Confirmed diagnosis of a solid tumor.

- Measureable lesion.

- Refractory to currently available treatment or no therapies available.

- 18 years or older.

- ECOG performance status of 0, 1, or 2.

- Obtained written informed consent.

Additional inclusion criteria for NSCLC patients EGFRwt with high c-MET expression:

- Written documentation of EGFRwt NSCLC.

- Written documentation of c-MET positivity.

- Patients should not have received more than three prior lines of antineoplastic
therapy for NSCLC.

- Presence of at least one measurable lesion as determined by modified RECIST version
1.1

Exclusion Criteria:

HCC with liver dysfunction greater than Child-Pugh A. Previous treatment with a c-MET
inhibitor or HGF-targeting therapy. Symptomatic CNS metastases that are neurologically
unstable or requiring increasing doses of steroids to control their CNS disease.

Any CNS deficits. For patients with GBM, CNS symptoms grade 2 or greater. Subjects with
significant or uncontrolled cardiovascular disease (eg, uncontrolled hypertension,
peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute
coronary syndrome) within 6 months of starting study treatment or heart attack within 12
months of starting study treatment.

Receiving anti-epileptic drugs that are known to be strong inducers of CYP3A4. Prior or
current anti-angiogenic therapy for patients with GBM. Radiation therapy within ≤ 4 weeks
(< 12 for GBM) prior to the first dose of study drug or limited field radiotherapy within ≤
2 weeks (< 12 weeks GBM) prior to the start of study treatment. Any persistent side effect
of prior radiotherapy must be resolved to ≤ Grade 1 prior to the first dose of study drug.

Additional exclusion criteria for NSCLC patients EGFRwt with high c-MET expression:

- Patients who have received more than three prior lines of antineoplastic therapies

- Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer therapy or
radiotherapy, except alopecia

- Patients have received anti-cancer therapies within the following time frames prior to
the first dose of study treatment:

- Conventional cytotoxic chemotherapy: ≤4 weeks (≤6 weeks for nitrosoureas and
mitomycin-C)

- Biologic therapy (e.g., antibodies): ≤4 weeks

- Non-cytotoxic small molecule therapeutics: ≤5 half-lives or ≤2 weeks (whichever
is longer)

- Other investigational agents: ≤4 weeks

- Radiation therapy (palliative setting is allowed.): ≤4 weeks

- Major surgery: ≤2 weeks

Other protocol-defined inclusion/exclusion criteria may apply.