A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma

CDX-014 is an antibody-drug conjugate that binds to a protein called TIM-1, which is found on
a high percentage of kidney cells that are clear or papillary and ovarian cancer cells that
are clear cell.

The study will enroll patients with advanced or metastatic renal cell carcinoma and ovarian
clear cell carcinoma to determine the safety and efficacy of CDX-014.

This study will include a Dose-Escalation Phase followed by a Cohort Expansion Phase

All patients enrolled in the study will be closely monitored to determine if there is a
response to the treatment as well as for any side effects that may occur.

Inclusion Criteria:

1. Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary
renal cell carcinoma or histologically confirmed clear cell ovarian carcinoma.

2. For RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or
are otherwise inappropriate candidates for all approved therapies. For OCCC, at least
one line of prior therapy with a platinum and taxane regimen.

3. Documented progressive disease based on radiographic, clinical or pathologic
assessment during or subsequent to last therapy.

4. Measureable (target) disease.

5. Must have available tumor tissue for TIM-1 expression testing

6. Life expectancy ≥ 3 months

7. If of childbearing potential (male or female), agrees to use effective contraception
during study treatment and for at least 6 months following last treatment dose.

Exclusion Criteria:

1. Prior therapy containing MMAE

2. Any prior cytotoxic chemotherapy regimen, including antibody drug conjugates for RCC
or cytotoxic chemotherapy within 3 weeks of study treatment for OCCC

3. Tyrosine kinase inhibitor (TKI) therapy within 2 weeks or at least 5 half-lives
(whichever is longer) prior to planned start of study treatment.

4. Monoclonal antibody therapy within 4 weeks prior to the planned start of study
treatment.

5. Radiation therapy within 4 weeks prior to start of study treatment (palliative
radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).

6. Major surgery or significant traumatic injury within 4 weeks prior to study entry.

7. Use of other investigational drugs within 2 weeks or 5 half-lives (whichever is
longer) prior to study treatment.

8. Concurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes or
infection), known infection with HIV, Hepatitis B or Hepatitis C.

9. Brain metastases, unless previously treated and asymptomatic and not progressive for 2
months.

10. Significant cardiovascular disease (including congestive heart failure).

11. Other malignancy except for treated and cured basal or squamous cell skin cancer,
cured in situ cancers, or other cancer from which the patient has been disease-free
for ≥ 3 years.

12. Active systemic infection requiring treatment. Infection controlled by oral therapy
will not be exclusionary.

13. Chronic use of systemic corticosteroid above an accepted physiologic dose (5mg per day
of prednisone or equivalent) within 7 days of enrollment except when used as
premedication