Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
Phase 2 Dose Expansion\*: select histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
\*expansion cohort indications to be prioritized based on data from Phase 1 dose escalation.
Prior treatment with TROP2-directed therapy is permitted.
Measurable disease as defined by RECIST v1.1 or RANO-BM.
Willingness to provide archival tumor tissue when available or to undergo pre-treatment biopsy if not available.
Mandatory pre- and on-treatment biopsies for enrichment cohorts in Phase 1 dose escalation and Phase 2 expansion cohorts if deemed medically feasible and safe.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function as defined by:
* Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL), without colony-stimulating factor support for the past 14 days
* Platelets ≥100.0 x 109/L (100 000/µL)
* Hemoglobin ≥9.0 g/dL
* Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases present)
Persistent toxicities from previous systemic antineoplastic treatments \>Grade 1, excluding alopecia and vitiligo.
Systemic antineoplastic therapy (including antiestrogen therapy) within 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug.
You may not be if
Active or progressing central nervous system (CNS) metastases or any evidence of leptomeningeal disease.
