Clinical Trials Directory

Trials / Completed

CompletedNCT03058289

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

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
111 (actual)
Sponsor
Intensity Therapeutics, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

INT230-6 is comprised of 3 agents in a fixed ratio - a cell permeation enhancer and two, potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. Nonclinical safety studies showed no findings following drug injection into healthy tissues. Historically physicians administer the two active drugs comprising INT230-6 by intravenous (IV) infusion to achieve a systemic blood level at the limit of tolerability. The objective is destroy both visible tumors and unseen circulating cancer cells (micro-metastases). Unfortunately, dosing drugs IV delivers only a small amount with a low concentration at the tumor site. This approach especially for late stage cancers is not highly effective and often quite toxic to the patient. Attempts at direct intratumoral injection with chemotherapeutic agents have not shown the ability to treat the injected tumor, non-injected tumors or micro-metastases. This lack of efficacy for local administration is due possibly to poor dispersion and a lack of cell uptake of the agents. Due to the use of the novel cell penetration enhancing agent INT230-6 treatment demonstrated strong efficacy in animals having large tumors. The Sponsor's in vivo, non-clinical data shows that INT230-6 thoroughly saturates and kills injected tumors. In addition, the drug induces an adaptive (T-cell mediated) immune response that attacks not only the injected tumor, but non-injected tumors and unseen micro-metastases. Cured animals become permanently immunized against the type of cancer that INT230-6 eliminates. Clinical trial IT-01 sought to determine the safety and potential efficacy of dosing INT230-6 directly into several different types of cancers. In addition, animal studies showed a strong synergy of INT230-6 with immune modulation agents. Thus, as part of study IT-01 the Sponsor seeks to understand the safety and efficacy of INT230-6 when administered in combination with immuno-therapeutic agents such as antibodies that target Programmed Cell Death (PD-1 or anti-PD-1) and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4 or anti-CTLA-4) receptors. This study sought to understand whether tumor regression can be achieved, and patient outcomes improved.

Conditions

Interventions

TypeNameDescription
DRUGINT230-6INT230-6 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.
BIOLOGICALanti-PD-1 antibodyThe anti-PD-1 antibody will be added concomitantly with INT230-6 as noted in cohort DEC and DEC2
BIOLOGICALanti-CTLA-4 antibodyThe anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC

Timeline

Start date
2017-02-09
Primary completion
2023-02-22
Completion
2023-02-22
First posted
2017-02-20
Last updated
2025-02-27
Results posted
2024-08-13

Locations

8 sites across 2 countries: United States, Canada

Regulatory

Source: ClinicalTrials.gov record NCT03058289. Inclusion in this directory is not an endorsement.