A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Exclusion Criteria

• •* No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
• •* Must have received prior anti-PD(L)1 therapy, unless contraindicated
• •Cohort 3: NSCLC-nonsquamous (Parts A and B)
• •* Must have unresectable locally advanced or metastatic disease
• •* Must have disease progression during or following systemic therapy
• •* Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
• •* Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease.
• •* Must have had prior platinum-based chemotherapy
• •* No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
• •* Must have received prior anti-PD(L)1 therapy, unless contraindicated
• •Cohort 4: HNSCC (Parts A and B)
• •* Must have unresectable locally recurrent or metastatic disease
• •* Must have disease progression during or following prior line of systemic therapy
• •* Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; OR
• •* Recurrence/progression within 6 months of last dose of platinum therapy given as part of a multimodal therapy in the curative setting
• •* No more than 1 line of cytotoxic chemotherapy for their advanced disease
• •* May have received prior anti-PD(L)1 therapy, unless contraindicated
• •Cohort 5: esophageal-squamous (Parts A and B)
• •* Must have unresectable locally advanced or metastatic disease
• •* Must have disease progression during or following systemic therapy
• •* Must have had prior platinum-based chemotherapy
• •* No more than 1 line of cytotoxic chemotherapy for their advanced disease
• •Cohort 6: gastric and GEJ adenocarcinoma (Parts A and B)
• •* Must have unresectable locally advanced or metastatic disease
• •* Must have received prior platinum-based therapy
• •* Must have disease progression during or following systemic therapy
• •* Participants with known human epidermal growth factor receptor 2 (HER2) overexpression must have received prior HER2-targeted therapy
• •* No more than 1 line of prior cytotoxic chemotherapy for their advanced disease
• •* Participants may have received prior anti-PD(L)1 therapy, unless contraindicated
• •Cohort 7: CRPC (Part B only)
• •* Must have histologically or cytologically confirmed adenocarcinoma of the prostate
• •* Participants with components of small cell of neuroendocrine histology are excluded
• •* Must have metastatic castration-resistant disease
• •* Must have been ≥28 days between cessation of androgen receptor-targeted therapy and start of study treatment
• •* Must have received no more than 1 prior line of androgen receptor-targeted therapy for metastatic castration-sensitive prostate cancer or CRPC
• •* No prior cytotoxic chemotherapy in the metastatic CRPC setting
• •* For participants who received cytotoxic chemotherapy in CSPC, at least 6 months must have elapsed between last dose of chemotherapy and start of study treatment
• •* No more than 1 prior line of cytotoxic chemotherapy for CSPC
• •Active concurrent malignancy or a previous malignancy within the past 3 years
• •Any anticancer therapy within 3 weeks of starting study treatment. Participants who are/were on adjuvant hormonal therapy for the treatment of malignancies with negligible risk of metastases are eligible.
• •Known active central nervous system lesions
• •Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher)
• •Ongoing sensory or motor neuropathy of Grade ≥2
• •Has received prior radiotherapy within 2 weeks of start of study treatment
• •History of interstitial lung disease.