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PEN-866 in Patients With Advanced Solid Malignancies

NCT03221400 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2022-02-17

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • Tarveda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Anish Thomas, MD · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2023-01-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221400 on ClinicalTrials.gov