Title
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that are Antigen-rich (START-001)

Description
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

Objective
Primary Objectives:

Phase 1 Dose Escalation:
-To characterize the safety, tolerability, and dose-limiting toxicities (DLTs), and determine the recommended Phase 2 dose (RP2D) of STAR0602

Phase 2 Dose Expansion:
-To further explore anti-tumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors

Secondary Objectives:

Phase 1 Dose Escalation:
-To evaluate preliminary anti-tumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors
-To evaluate the PK profile of STAR0602 in serum after single- and repeated IV infusions

Phase 2 Dose Expansion:
-To further evaluate the anti-tumor activity of STAR0602
-To evaluate the PK profile of the STAR0602 in serum after single- and repeated IV infusions
-To further characterize the safety and tolerability of STAR0602

Phase 1 and Phase 2 Dose Escalation and Dose Expansion Secondary Objective:
-To assess ADA formation after IV single- and repeat dose administration of STAR0602

Treatment This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Anal; Breast; Cervix; Colon and Rectum; Genitourinary cancers, other; Head and Neck; Kidney; Lung; Melanoma/Skin cancer; Ovary; Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital