Clinical Trial

Testing Treatment for Advanced Refractory Cancers

Study Description

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

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

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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. The drug is stored frozen and must be dosed at room temperature. Escalation of the drug dose and number of injected tumors is possible in subsequent treatment sessions. The drug dose to be administered is set by the tumor volume of the target lesions - not the subject's body surface area

Biological - anti-PD-1 antibody

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

Biological - anti-CTLA-4 antibody

The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC subject to approval by the study steering committee

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03058289

ParticipAid ID

ZdPEWe