AVID100 in Advanced Epithelial Carcinomas

On Day 1 of study, patients will receive study drug administered by 2-hour IV infusion in a
fixed 100 mL volume. AVID100 will be administered once every 3 weeks (Q3W) with
administration on Day 1 of the first week, followed by a 3-week recovery period. In Phase 2a
AVID100 will be administered at a dose of 220 mg/m2.

Evidence of progressive disease at any point in the study will necessitate withdrawal of the
patient from further participation so that alternative management of their malignancy may be
considered. All patients will be followed to further evaluate safety as well as evidence of
the anti-tumor effects of AVID100 in these selected patient populations. If anti-tumor
activity is observed additional patients may be added to the planned Phase 2a patient
populations to further characterize these effects.

Inclusion Criteria (Phase 1):

1. Patients with a documented (histologically- or cytologically-proven) solid tumor
epithelial carcinoma that is locally advanced or metastatic

2. Patients with a malignancy that is either refractory to standard therapy, or for which
no standard therapy is available

3. Patients with a malignancy that is currently not amenable to surgical intervention due
to either medical contraindications or non-resectability of the tumor

4. Phase 1a Dose-Escalation Cohorts: Patients with measurable or non-measurable disease
according to RECIST, v1.1 criteria. To include patients reasonably likely to express
EGFR.

Inclusion Criteria (Phase 2a)

1. Patients with measurable disease according to RECIST, v1.1 criteria.

2. Patients with triple negative breast cancer who are either EGFR 2+ or EGFR 3+ by
validated IHC assay.

3. Patients with squamous non-small cell lung cancer who are EGFR 3+ by validated IHC
assay.

4. Patients with squamous cell carcinoma of the head and neck who are EGFR 3+ by
validated IHC assay.

5. Patients whose malignancy is either refractory to standard therapy, or for which no
standard therapy is available

6. Patients whose malignancy is currently not amenable to surgical intervention due to
either medical contraindications or non-resectability of the tumor

Patients to be Excluded (patients must not meet any of the following criteria Phase 1 only)

1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and
fertile men with WOCBP partner(s), not using and not willing to use a medically
effective method of contraception.

2. Patients with known central nervous system (CNS) or leptomeningeal metastases, or
spinal cord compression not controlled by prior surgery or radiotherapy, or patients
with symptoms suggesting CNS involvement for which treatment is required

3. Patients with a malignancy other than that of epithelial origin

4. Patients with hematologic abnormalities at baseline

5. Patients with a significant cardiovascular disease or condition

6. Patients with a significant ocular disease or condition

7. Patients with a significant pulmonary disease or condition

8. History of pneumonia within 6 months prior to the first study drug administration

9. Patients with significant gastrointestinal (GI) abnormalities

10. Patients with non-healing wounds on any part of the body

Patients to be Excluded (patients must not meet any of the following criteria Phase 2a
only)

1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and
fertile men with WOCBP partner(s), not using and not willing to use a medically
effective method of contraception.

2. Patients with known central nervous system (CNS) or leptomeningeal metastases, or
spinal cord compression not controlled by prior surgery or radiotherapy, or patients
with symptoms suggesting CNS involvement for which treatment is required

3. Patients with a malignancy other than EGFR-overexpressing triple negative breast
cancer, squamous histology non-small cell lung cancer, or squamous cell carcinoma of
the head and neck.

4. Patients with hematologic abnormalities at baseline

5. Patients with a significant cardiovascular disease or condition

6. Patients with a significant ocular disease or condition

7. Patients with a significant pulmonary disease or condition

8. History of pneumonia within 6 months prior to the first study drug administration

9. Patients with significant gastrointestinal (GI) abnormalities

10. Patients with non-healing wounds on any part of the body

11. Patients without measurable disease according to RECIST v1.1

12. Patients with an active second malignancy within the last 2 years prior to entry

Drugs and Other Treatments to be Excluded

1. Any antineoplastic agent for the primary malignancy (standard or investigational),
without delayed toxicity, within 4 weeks, 5 plasma half-lives, or twice the duration
of the biological effect, whichever is shortest, prior to first study drug
administration and during study with the exception of: Nitrosoureas and nitrogen
mustard within 6 weeks prior to first study drug administration and during study

2. Any other investigational treatments during study. This includes participation in any
medical device or other therapeutic intervention clinical trials.

3. Radiotherapy for target lesions within 4 weeks prior to first study drug
administration and during study

4. Herbal preparations or related over-the-counter (OTC) preparations/supplements
containing herbal ingredients aimed at treating the underlying malignancy within 2
weeks prior to first study drug administration and during study

5. Strong inhibitors and/or inducers of cytochrome P450 (CYP) isoenzyme 3A4 within 2
weeks prior to first study drug administration and during study

6. Immunosuppressive or systemic hormonal therapy within 2 weeks prior to first study
drug administration and during study.

7. Prophylactic use of hematopoietic growth factors within 1 week prior to first study
drug administration and during Cycle 1 of study; thereafter prophylactic use of growth
factors is allowed as clinically indicated