Protocol Title: A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER).

Sponsor: Lisata

Protocol Number: LSTA1-P02

Key Criteria

1 measurable lesion per RECIST  

For HNSCC patient cohort:
– histologically confirmed recurrent or metastatic HNSCC that is unresectable or considered incurable by local therapies and that has progressed after first-line immunotherapy

For Cholangio patient cohort:
– confirmed metastatic or unresectable cholangio with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible.

For Esophageal patient cohort:
– locally advanced or metastatic
– documented clinical or radiographic disease progression by RECIST 1.1 after first-line immunotherapy.

Talking Points

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