CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2

This is an observational data collection study evaluating how physicians utilize therapeutic
sensitivity information ascertained with CANscript, and subsequently describing clinical
outcomes (clinical response and survival) resulting from their therapeutic selection.

Potential patients presenting for study enrollment will provide written informed consent and
will subsequently be screened per inclusion/ exclusion criteria. Once enrolled, a biopsy &
blood draw will be scheduled to obtain material for CANscript testing. Imaging will also be
scheduled if a fresh image (obtained within 14 days of planned treatment initiation) is not
available. Prior to submitting a fresh tissue sample for CANscript, the treating physician
will select any number of therapies being considered for treatment, and will assign a
priority ranking to those therapies (priority #1 through priority #N, with #1 representing
their most preferred therapeutic option for the patient, and #N representing the number of
their least preferred of the appropriate potential therapies). Prioritized therapies can be
either single-agent therapeutics or combination regimens. All ranked therapeutic options must
be available for individual patient at the time of selection. The prioritized list of
preferred therapies will be sent to the testing laboratory (Mitra Biotech, Inc.) at least 2
days before the biopsy and blood draw are performed. Fresh tumor and blood samples will
subsequently be sent to the testing laboratory for receipt within 24 hours of biopsy.

Inclusion Criteria:

1. Male or female patient ≥18 years old

2. ECOG performance status of ≤ 2

3. The patient's tumor must be amenable to a tumor biopsy sampling, so that CANscript can
be performed

4. The patient must have disease that is measurable by standard imaging techniques, per
the RECIST 1.1 (For patients with prior radiation therapy, measurable lesions must be
outside of any prior radiation field[s], unless disease progression has been
documented at that disease site subsequent to radiation)

5. Histologically- or cytologically-confirmed:

A Locally advanced or metastatic HNSCC; B Locally advanced or metastatic TNBC; C
Locally advanced or metastatic Stage 3b or 4 NSCLC after failure of appropriate 1st
line therapy (i) Patients with EGFR or ALK mutations must have received previous
appropriate therapy; D Locally advanced or metastatic epithelial ovarian, fallopian
tube, or primary peritoneal carcinoma, after failure of 1st line platinum-based
chemotherapy (i) Recurrent or persistent stage 3 or 4 disease requiring relapse
histologic documentation; E Stage IV metastatic CRC

6. Patient has signed informed consent prior to initiation of any study-specific
procedures

Exclusion Criteria:

1. The patient has persistent clinically significant toxicities (Grade ≥2) from previous
anticancer therapy (excluding chronic Grade 2 chemotherapy-related neuropathy which is
permitted, and excluding Grade 2-3 laboratory abnormalities if they are not associated
with symptoms, are not considered clinically significant by the Investigator, and can
be managed with available medical therapies).

2. The patient has received treatment with chemotherapy, external-beam radiation, or
other systemic anticancer therapy within 14 days prior to study entry (42 days for
prior nitrosourea or mitomycin-C). (Patients could have received supportive care
therapeutics as appropriate).

3. The patient has an additional active malignancy that may confound the assessment of
the study endpoints. Patients with a past cancer history (active malignancy within 2
years prior to study entry) with substantial potential for recurrence must be
discussed with the Sponsor before study entry. Patients with the following concomitant
neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ
(including transitional cell carcinoma, cervical intraepithelial neoplasia),
organ-confined prostate cancer with no evidence of progressive disease.

4. The patient has clinically significant cardiovascular disease (e.g., uncontrolled or
any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled
angina, history of myocardial infarction, unstable angina or stroke within 6 months
prior to study entry, uncontrolled hypertension or clinically significant arrhythmias
not controlled by medication).

5. The patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic
obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the
Investigator would put the patient at significant risk for pulmonary complications
during the study.

6. The patient has known active or suspected brain or leptomeningeal metastases. (Central
nervous system [CNS] imaging is not required prior to study entry unless there is a
clinical suspicion of CNS involvement). Patients with stable, treated brain metastases
are eligible provided there is no evidence of CNS disease growth on imaging for at
least 6 weeks following radiation therapy or other loco-regional ablative therapy to
the CNS.

7. The patient is receiving immunosuppressive therapy for prophylaxis following a prior
organ transplant (solid organ or allogeneic stem cell). Corticosteroid therapy is
permitted.

8. The patient has uncontrolled intercurrent illness including, but not limited to,
uncontrolled infection, disseminated intravascular coagulation, or psychiatric
illness/social situations that would limit compliance with study requirements.

9. The patient is pregnant or breast-feeding. The patient has known positive status for
human immunodeficiency virus active or chronic Hepatitis B or Hepatitis C.