A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors

Condition studied

Metastatic or locally advanced SST2-positive neuroendocrine neoplasms in adults

Eligibility

Primary endpoint

Dose Escalation Phase: Incidence and severity of DLTs., Dose Escalation Phase: Incidence and severity of AEs and SAEs at each dose level., Dose Escalation Phase: Incidence of AEs leading to discontinuation from study drug., Dose Expansion Phase: Nature, incidence, and severity of AEs and SAEs at the Expansion Dose., Dose Expansion Phase: Interruptions at the Expansion Dose.

Endpoint detail

Dose Escalation Phase: Plasma PK parameters of CRN09682, including Cmax, tmax, AUC0-last, AUC0-inf, and t½., Dose Escalation Phase: Plasma PK parameters of MMAE, including Cmax, tmax, and AUC0-last., Dose Escalation Phase: ORR=PR+CR by RECIST version 1.1 criteria., Dose Escalation Phase: DOR, defined as time from achieving at least a RECIST PR to disease progression., Dose Escalation Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria., Dose Escalation Phase: Safety, tolerability, PK, and response by dose level., Dose Expansion Phase: ORR=PR+CR by RECIST version 1.1 criteria., Dose Expansion Phase: DOR, defined as time from achieving at least a RECIST version 1.1 PR to disease progression., Dose Expansion Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria., Dose Expansion Phase: Radiographic PFS (defined as time from enrollment to disease progression)., Dose Expansion Phase: Changes in somatostatin receptor imaging., Dose Expansion Phase: Plasma concentrations of CRN09682 and MMAE at predose and EOI.