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ADVANCED SOLID TUMORS: SCLC, GEJ, PDAC, Endometrial: PEN-866-001

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Anal cancer, Pancreatic cancer, PDAC, Cervix, cervical cancer, Gastric cancer, Gastroesophageal cancer, SCLC, Small cell lung cancer, penile, vulvar

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or later

Investigational Agent

PEN-866

Drug Class

HSP-90 inhibitor

PI

Dan Vaena, MD

Sponsor

Tarveda Therapeutics

Path

adenocarcinoma or squamous cell carcinoma

Key Eligibility Criteria Details
  • One of the following malignancies
    • Small cell lung cancer: locally recurrent or metastatic SCLC whose disease has progressed after at least 1 prior line of chemo
    • Gastric or GEJ adenoCA: Disease that has progressed after at least 1 prior line of chemo
    • SCC of genitalia (anus, cervix, vulva, or penis): disease that has progressed after at least 1 prior line (adjuvant counts as prior line)
    • Pancreatic CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
    • Endometrial CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
  • ECOG PS 0-1
  • Measurable disease
  • No prior topoisomerase I inhibitor
  • No symptomatic CNS involvement
  • No known HIV/HBV/HCV
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