PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors

• CX-188 (Drug): CX-188

Primary outcomes

• The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy [21 days]

Secondary outcomes

• The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy [2 years]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. histologically confirmed diagnosis of metastatic or advanced unresectable solid tumors that progressed on standard therapy
2. agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study 3. At least 18 years old

Exclusion Criteria:

1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic
3. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C
4. History of or current active autoimmune diseases
5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications
6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug
8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug

• Yifah Yaron, MD, Study director, CytomX Therapeutics