A Phase 1/2a, open-label multicenter study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PEN-221 in patients with somatostatin receptor 2 expressing advanced cancers, including gastroenteropancreatic or lung o

Protocol: 
AAAQ9284
Phase: 
I/II

A Phase 1/2a, open-label multicenter study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PEN-221 in patients with somatostatin receptor 2 expressing advanced cancers, including gastroenteropancreatic or lung o

The purpose of this study is to learn how the study drug, PEN-221, affects the body and how the body affects PEN-221. The study will look at how well research subjects/participants with advanced cancer tolerate PEN-221. The study will also look for the most useful dose of PEN-221, learn how the amount of PEN-221 changes over time in blood, and look at whether PEN-221 may make tumors get smaller or disappear.

Are you Eligible? (Inclusion Criteria)

1)SSTR2 positive tumor as assessed using a SARI agent and as defined by tumor uptake greater
than liver uptake.
2) Histologically- or cytologically-confirmed solid tumor in 1 of the following categories:
o Advanced SCLC or LCNEC of the lung having progressed after 1 or more prior lines
of anticancer chemotherapy, or
o Advanced low or intermediate grade GEP or lung or thymus NET, or NET of
unknown primary, having progressed after 1 or more prior lines of anticancer
therapy, unless no standard treatments are available or unless such treatments are
deemed not appropriate, or
o Advanced paraganglioma, pheochromocytoma, medullary thyroid carcinoma, Merkel
cell carcinoma, or high grade extrapulmonary NEC, having progressed after 1 or
more prior lines of anticancer therapy, unless no standard treatments are available or
unless such treatments are deemed not appropriate
3) Patient must have at least 1 site of tumor that is accessible to biopsy and that is considered by
the Investigator to be low risk and of sufficient size to undergo a biopsy procedure
4) ECOG PS of 0 - 1

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States