CompletedPhase 1/2

PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers

United States89 participantsStarted 2016-12-08

Plain-language summary

Protocol PEN-221-001 is an open-label, multicenter Phase 1/2a study evaluating PEN-221 in patients with SSTR2 expressing advanced gastroenteropancreatic (GEP) or lung or thymus or other neuroendocrine tumors or small cell lung cancer or large cell neuroendocrine carcinoma of the lung.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * M/F at least 18 years old * ECOG performance status 0 or 1 * Adequate bone marrow, liver, and kidney function within 2 weeks prior to first dose * Serum potassium, calcium, magnesium, phosphorus within normal limits (may be supplemented) * Adequate birth control * Somatostatin receptor 2 positive tumor as assessed at pre-screening or within 180 d of first drug dose using indium SPECT or gallium PET Patients in Phase 1 must have a histologically or cytologically-confirmed solid tumor in 1 of the following categories: * Advanced small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) of lung progressed after at least 1 line of anticancer chemotherapy * Advanced low or intermediate grade gastroenteropancreatic or lung or thymus neuroendocrine tumor (NET), or NET of unknown primary, progressed after at least 1 line of anticancer therapy (unless no standard treatments available or such treatments are deemed not appropriate) * Advanced paraganglioma, pheochromocytoma, medullary thyroid carcinoma, Merkel cell carcinoma, or high grade extrapulmonary neuroendocrine carcinoma having progressed after 1 or more lines of anticancer chemotherapy (unless no standard treatments available or such treatments are deemed not appropriate) For patients enrolling once escalation is complete (Phase 2a), disease must be measurable per RECIST 1.1 criteria with last imaging performed within 28 days prior to first drug dose In addition to the criterion lis…

What they're measuring

Phase 1: Maximum Tolerated Dose of PEN-221 and Recommended Phase 2a Dose (RP2D)

Timeframe: Up to 4 weeks in the first cohort and up to 3 weeks for each subsequent cohort

Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Timeframe: Up to 4 weeks in the first cohort and up to 3 weeks for each subsequent cohort

Phase 2a: Percentage of Gastrointestinal Mid-gut NETs and Pancreatic NETs Participants Who Achieved Clinical Benefit as Determined by RECIST 1.1

Timeframe: Baseline and every 9 weeks up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020).

Phase 2a: Number of Small Cell Lung Cancer (SCLC) Participants Who Achieved an Objective Response of Complete Response (CR) or Partial Response (PR) as Defined by RECIST 1.1.

Timeframe: Baseline and every 6 weeks up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020).

Phase 2a: Duration of Response (DOR) for Small Cell Lung Cancer (SCLC)

Timeframe: From the date of first treatment through the date of first documented progression, assessed up to data cut-off (31 Jul 2020).

Trial details

NCT IDNCT02936323

SponsorTarveda Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-31

Results submitted2021-08-12

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