Clinical Trials

Key Inclusion Criteria:

- Pathologically confirmed advanced solid tumor for which standard therapy proven to
provide clinical benefit does not exist or is no longer effective.

- Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1.

- Progressive disease, either measurable on physical examination or imaging by Response
Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor
marker(s).

- Adequate organ function based on laboratory values.

- If there is a known history of brain metastases, either treated or untreated, the
disease must be stable.

- Willing and able to provide written Informed Consent and comply with the requirements
of the study.

Key Exclusion Criteria:

- Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.

- Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive
therapy, corticosteroids, or growth factor treatment within 14 days prior to
initiation of study drug.

- Presence of an acute or chronic toxicity of prior chemotherapy, that has not resolved
to ≤Grade 1, as determined by CTCAE v 4.0.

- Receipt of more than 3 prior regimens of cytotoxic chemotherapy for metastatic
disease.

- Bone marrow reserve which is not adequate for participation in this trial.

- Radiotherapy within 28 days prior to baseline.

- Fraction of radiotherapy to >25 % of bone marrow.

- Major surgery within 28 days prior to initiation of study drug.

- Active bacterial, viral, or fungal infection requiring systemic therapy.

- Known human immunodeficiency virus or acquired immunodeficiency syndrome related
illness.

- Clinically significant hearing impairment, as judged by the Principal Investigator.

- Uncontrolled cardiovascular abnormalities.

- Previous malignancy, except for non-squamous-cell carcinoma of skin or carcinoma
in-situ of the uterine cervix, unless the tumor was treated with curative intent more
than 2 years prior to study entry.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.