A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6

Summary

This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Sponsor also tested INT230-6 in combination with anti-PD-1 and anti-CTLA-4 antibodies.

Conditions

• Breast Cancer
• Head and Neck Cancer
• Squamous Cell Carcinoma
• Lymphoma
• Pancreatic Cancer
• Liver Cancer
• Colon Cancer
• Lung Cancer
• Bile Duct Cancer
• Chordoma of Sacrum
• Sarcoma

Interventions

DRUG

INT230-6

INT230-6 is clear sterile solution administered by injection directly into the tumor to be treated. The product contains a cell permeation agent with cisplatin and vinblastine sulfate at fixed concentrations.

BIOLOGICAL

anti-PD-1 antibody

The anti-PD-1 antibody will be added concomitantly with INT230-6 as noted in cohort DEC and DEC2

BIOLOGICAL

anti-CTLA-4 antibody

The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Intensity Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Brian Schwartz, M.D. · Intensity Therapeutics

• Lillian Siu, M.D., FRCP · Princess Margaret Hospital, Canada

• Anthony El-Khoueiry, M.D. · USC Norris and HOAG sites

• Anthony J. Olszanski, M.D., RPh · Fox Chase Cancer Center

• Nilofer Azad, M.D. · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Giles F Whalen, M.D. · UMASS Memorial Medical Group

• Matthew Ingham, M.D. · Columbia University

• Luis Camacho, M.D. · Center for Oncology and Blood Disorders

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-09

Primary Completion

2023-02-22

Completion

2023-02-22

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations