The purpose of this study is to determine the appropriate dosage, safety and
effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. 'Advanced solid tumours'
refers to cancers that can occur in several places, including cancers in organs or
tissues that have spread from their original site to nearby tissues or other parts of the
body.
In this study, all participants will receive the study drug, which will be taken by mouth
(orally).
Additional locations may be listed on ClinicalTrials.gov for NCT06305247.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale UniversityStatus: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-TrumbullStatus: Active
Name Not Available
The study consists of two parts, called Phase I and Phase IIa.
Phase I is designed to assess the safety of increasing doses of IPN01194 in participants
with specific types of advanced solid tumours.
The aim of this "dose escalation" phase is to find the dose range showing activity on the
tumor that can be tolerated by the participants, and to determine the two doses for
further testing in Phase IIa. Phase I will assess how the body processes and responds to
the study drug when administered with and without food.
In Phase IIa, participants with selected single tumour type will be invited to take part.
During this phase, the two dose levels of the study drug identified from Phase I will be
tested. Participants will take the study drug one of the two dose levels. Each
participant will be assigned to a dose level at random (by chance).
Each phase will consist of three periods:
1. A period to assess eligibility (screening period) that will take up to 28 days.
2. A treatment period of at least 28 days that will require at least two visits for the
first month followed by one visit every month. There will be also one visit, at the
end of treatment, at least 30 days after the last administration of study drug.
3. A follow-up period (Phase IIa participants only), where every 3 months, participants
will be contacted by phone, until death or the study cut-off date, whichever comes
first.
Participants will undergo blood samplings, urine collections, physical examinations, and
clinical evaluations. They may continue some other medications, but the details need to
be recorded.
If in the opinion of the investigator a participant is continuing to experience clinical
benefit after the cut-off date, the participant may remain in the study and continue to
receive the study drug until either disease progression, unacceptable toxicity or other
withdrawal criteria are met.
