West Cancer Center

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

Site Link

NCT03221400

Malignancy

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

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd or later

Investigational Agent

PEN-866

Drug Class

HSP-90 inhibitor

Dan Vaena, MD

Sponsor

Tarveda Therapeutics

Phase

Phase 1

Status

Closed to Accrual

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