Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Required: PD-L1 (CD274) CPS >= 1 (CPS >= 1)

Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test

Required: PD-L1 (CD274) CPS < 1 (CPS < 1)

Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx

Must have received: anti-PD-1 therapy — metastatic or locally advanced

patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting

Must have received: chemotherapy — unresectable and/or metastatic

must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy

Must have received: systemic therapy — unresectable and/or metastatic

received no more than 2 prior lines of systemic treatments for treatment of unresectable and/or metastatic disease

Must have received: systemic therapy

must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens

Cannot have received: anti-EGFR antibody

Exception: prior treatment with radiotherapy in the adjuvant setting is allowed

No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed)

Cannot have received: anti-EGFR antibody

Exception: radiosensitizing agents and multimodal treatment for locally advanced disease allowed

No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease)

Cannot have received: immune checkpoint inhibitor

No prior history of immune checkpoint inhibitors

Cannot have received: anti-TGFβ therapy

Prior treatment with any anti-TGFβ therapy

Cannot have received: anti-EGFR antibody (cetuximab)

Prior history of Grade ≥ 2 intolerance or hypersensitivity reaction to cetuximab or other anti-EGFR therapy or other murine proteins or prior discontinuation of therapy in the setting of toxicity related to treatment