NCT03221400

PEN-866 in Patients With Advanced Solid Malignancies

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Tarveda Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

Detailed description

Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent). Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy. Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies.

Conditions

• Carcinoma
• Endometrial Adenocarcinoma
• Neoplasms
• Squamous Cell Carcinoma of the Anus
• Adenocarcinoma of the Pancreas
• Advanced Cancer
• Solid Tumor
• Solid Carcinoma
• Squamous Cell Carcinoma of the Cervix
• Squamous Cell Carcinoma
• Squamous Cell Carcinoma of the Vulva
• Squamous Cell Carcinoma of the Penis
• Gastric Cancer
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Small-cell Lung Cancer
• Small Cell Lung Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	PEN-866 Sodium	PEN-866 Sodium is a miniaturized conjugate that comprises an HSP90 targeting ligand linked to SN-38, the active metabolite of irinotecan. PEN-866 is available as a sterile lyophilized powder for solution for infusion.
DRUG	fluorouracil	Fluorouracil 2400 mg/m2 IV
DRUG	Folinic acid	Folinic acid 400 mg/m2 IV
DRUG	Niraparib	Niraparib

Timeline

• Start date: 2017-08-29
• Primary completion: 2023-01-01
• Completion: 2023-06-01
• First posted: 2017-07-18
• Last updated: 2022-02-17

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study