CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 111 enrolled
Drug / intervention
INT230-6 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03058289
NCT03058289Phase 2Completed
CompareCT.gov

A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers

Intensity Therapeutics, Inc.·interventional·Posted Feb 20, 2017·Updated Feb 27, 2025

In Brief

A Phase 2 clinical trial evaluating INT230-6, anti-PD-1 antibody, and 1 other intervention for Breast Cancer and 10 related conditions. Completed, enrolled 111 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma, Pancreatic Cancer, Liver Cancer, Colon Cancer, Lung Cancer, Bile Duct Cancer, Chordoma of Sacrum, Sarcoma
CountriesCanada, United States
CollaboratorsMerck Sharp & Dohme LLC, Bristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 20, 2017
Enrollment StartFeb 9, 2017
Primary CompletionFeb 22, 2023
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 9.4 years ago

Interventions

INT230-6drug

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.

anti-PD-1 antibodybiological

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

anti-CTLA-4 antibodybiological

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