Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors

Inclusion Criteria:

1. Must be ≥ 18 years of age at the time of informed consent.

2. All participants must be willing and able to give informed consent.

3. For patients with cancer: have a history of histologically or cytologicallyconfirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cellcarcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOCCT or MRI within 12 weeks prior to giving consent that indicates the presence of atleast 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment.SOC images must be available for submission to the centralized imaging reader asreference.

4. Screening laboratory values within 30 days prior to administration of the studydrug:

5. WBC ≥ 1200/μL

6. ANC ≥ 1000/μL

7. Platelets ≥ 75,000/μL

8. Hemoglobin ≥ 9.0 g/dL

9. Creatinine ≤ 1.5 mg/dL

10. AST/ALT ≤ 3 x ULN for patients with no liver metastases.

11. AST/ALT ≤ 5 x ULN for patients with liver metastases.

12. Bilirubin ≤ 1.5 mg/dL except for participants with Gilbert's disease.

13. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.

14. All participants must have baseline pulse oximetry ≥ 95% on room air.

15. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.

16. Willing to refrain from taking illicit drugs one week prior to PET scanning andthrough the follow-up phone call on Day 3 (+2 days).

17. Willing to refrain from donating blood for 4 weeks after administration of RAD301.

18. Have not participated in any other research study that requires taking medicationwithin 4 weeks (or 10 half-lives, whichever is shorter) from the time of informedconsent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoingparticipation in another study should be discussed with the Sponsor.

Exclusion Criteria:

1. Participant may not be a member of a vulnerable population defined as participantswho are not able to understand the nature of the trial and provide informed consentor who have any medical, psychological or sociological condition that in the opinionof the investigator would interfere with the ability to give consent or interferewith protocol compliance.

2. Women may not be pregnant or breastfeeding. Women of childbearing potential musthave a negative urine pregnancy test within 72 hours prior to administration ofRAD301.

3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic ora diagnostic agent.

4. History, physical examination, or clinical laboratory tests suggestive of acondition, disorder, or disease that could adversely affect drug absorption,distribution, metabolism, or elimination of RAD301, including chronic liver or renalfailure.

5. Unable to tolerate the study procedures.

6. Patients with brain metastases are eligible as long as there is no requirement forhigh doses of systemic corticosteroids that could result in immunosuppression (>10mg/day prednisone equivalents) for at least 2 weeks prior to study drugadministration. An MRI is not required to rule out brain metastases orleptomeningeal metastases

7. Any serious or uncontrolled medical disorder that, in the opinion of theinvestigator, may increase the risk associated with study participation or studydrug administration, or interfere with the interpretation of study results.

8. Clinically significant cardiovascular/ cerebrovascular disease defined as cerebralvascular accident, stroke, carotid artery disease transient ischemic attach (< 6months prior to enrollment), myocardial infarction (< 6 months prior to enrollment),unstable angina, congestive heart failure (New York Heart Association ClassificationClass >II) or serious cardiac arrhythmia.

9. Other than the tumor types being studied, a prior malignancy active within theprevious 3 years except for locally curable cancers that have been apparently cured,such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinomain situ of the prostate, cervix or breast.

10. Participants with active, known or suspected autoimmune disease. Participants withvitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmunecondition only requiring hormone replacement, psoriasis not requiring systemictreatment, or conditions not expected to recur in the absence of an external triggerare permitted to enroll.

11. Participants who underwent major surgery within 4 weeks of administration of studydrug (not including diagnostic laparoscopy).