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

Title
Tarveda PEN-866-001 (Phase 1)
Study Title

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

Site Link
Malignancy
Anal cancer, Pancreatic cancer, PDAC, Cervix, cervical cancer, Gastric cancer, Gastroesophageal cancer, SCLC, Small cell lung cancer, penile, vulvar
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd or later
Investigational Agent
PEN-866
Drug Class
HSP-90 inhibitor
PI
Dan Vaena, MD
Sponsor
Tarveda Therapeutics
Phase
Status
Key Eligibility Criteria
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
Objective
  • Primary:
    • DCR
    • ORR
  • Secondary
    • PK
    • DOR
    • PFS
    • OS
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
adenocarcinoma or squamous cell carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X