A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

Required: CD276 expression (testing required; no minimum threshold for eligibility) (testing required; no eligibility threshold specified)

willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of B7-H3 level and other biomarkers if no contraindication. Note: there is no minimum B7-H3 expression level mandatory for entry into the study.

Must have received: platinum-based chemotherapy — advanced/unresectable or metastatic NSCLC

Has received prior treatment with platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 antibody-based regimen in the advanced/unresectable, or metastatic setting unless unable or unwilling

Must have received: anti-PD-1 therapy — advanced/unresectable or metastatic NSCLC, melanoma, HCC, cervical cancer

Previously treated with a PD-1 or PD-L1 inhibitor

Must have received: anti-PD-L1 therapy — advanced/unresectable or metastatic NSCLC, melanoma, HCC, cervical cancer

Previously treated with a PD-1 or PD-L1 inhibitor

Must have received: docetaxel (docetaxel) — CRPC

Having received prior docetaxel (before or after an AR-targeted therapy). Docetaxel rechallenge was allowed.

Must have received: novel hormone therapy — CRPC

Having received prior novel hormone therapy.

Must have received: systemic chemotherapy doublet (paclitaxel, cisplatin, carboplatin, topotecan, bevacizumab) — cervical cancer

Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: d. paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or e. paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or f. paclitaxel + topotecan + bevacizumab + anti-PD-(L)1 agent

Cannot have received: B7-H3 targeted therapy

Prior treatment with B7-H3 targeted therapy

Cannot have received: antibody-drug conjugate

Exception: with topoisomerase inhibitor

Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan)

Cannot have received: TOP I inhibitor (irinotecan, topotecan)

Prior treatment regimens with irinotecan, topotecan or any other TOP I inhibitor including investigational TOP I inhibitors are not allowed