A Phase 1/2 Dose Escalation And Dose Expansion Study Of BA3021 Alone And In Combination With Nivolumab In Patients With Advanced Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Non-small Cell Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Phase 2: Patients must: a. Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC or melanoma. b. Have prior disease progression on or after receiving a PD-1/L-1 (NSCLC and melanoma patients), EGFR inhibitor (NSCLC), or ALK inhibitor (NSCLC). 2) Documented progression according to RECIST v1.1 criteria within the 6 months prior to enrollment. 3) In Phase 2, patients must have ROR2-positive disease determined by BioAtla ROR2 IHC assay based on archival tissue or biopsy; a minimum of 3 core samples are required to ensure a sufficient quantity of cells are obtained. For Phase 1 dose expansion, the ROR2 expression cutoff is =1+ in =10% tumor cells. For Phase 2, based on Phase 1 data, a tumor membrane percent score (TmPS) greater than or equal to 50 (consisting of 1+, 2+, and 3+ intensities) is considered positive.

You may not be eligible for this study if the following are true:

  • 1) Patients must not have known non-controlled central nervous system (CNS) metastasis. 2) Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. 3) Patients must not have a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled diseases, including pulmonary fibrosis, acute lung diseases, etc. 4) Patients must have acceptably tolerated prior PD-1 treatment. Prior PD-1 treatment must not have been discontinued for severe or recurrent severe toxicity (including myocarditis, or other myocardiotoxicity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, nephritis, Type 1 diabetes, thrombocytopenia).

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.