Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called PF-0793440 (the study drug). We want to know how well it works on its own and in combination with other drugs for the treatment of different cancers in people who have KRAS mutation(s).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor cancers
- Have a documented mutation in the KRAS gene
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
This study is divided in two parts: Part 1 and Part 2.
The goal of Part 1 is to determine the maximum tolerated dose (MTDM - the highest dose that is safe and tolerable for study participants) and the recommended dose for expansion (RDEM - the dose to give to many other participants) for the study drug when it is taken on its own.
The goal of Part 2 is to see how well the study drug works against your cancer when it is take on its own or taken in combination with other cancer drugs.
The part of the study in which you participate will depend on when you join the study. In addition, each part of the study has multiple cohorts. Your cohort assignment in Part 1 will depend on when you join the study, and your assignment in Part 2 will depend on what type of cancer you have.
Part 1
Part 1 will have multiple cohorts:
- Cohort A: If you are in this cohort, you will get doses of the study drug that start low and slowly increase as each dose level is confirmed to be safe and tolerable until we find the MTDM.
- Cohort B: If you are in this cohort, you will get the study drug at the MTDM to confirm that the RDEM is safe and tolerable in a broader range of participants.
- Cohort C: If you are in this cohort, you will have two tumor biopsies done, one before you start taking the study drug and one while you are getting the study drug.
- Cohort D: If you are in this cohort, you will first take the study drug on an empty stomach for about 2 weeks. You will then switch to taking the study drug for one dose after eating, and then go back to taking it on an empty stomach. This will help us understand if taking the study drug with food changes the way it is absorbed into your body and whether it improves or worsens any potential side effects.
- Cohort E: This cohort will be an option if a specific cancer type shows early signs of improving with the study drug alone. This cohort is optional and dependent on what happens in cohorts A-D.
- Cohort A1: Participants who have pancreatic ductal adenocarcinoma (PDAC) with a KRAS mutation and have received two or three lines of treatment can join this cohort.
- Cohort B1: Participants who have colorectal cancer (CRC) with a KRAS mutation and have received two or three lines of treatment can joint this cohort.
- Cohort C1: Participants who have non-small cell lung cancer (NSCLC) with a KRAS mutation and have received two to three lines of treatment can join this cohort.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A PHASE 1 OPEN-LABEL STUDY OF PF-07934040 AS A SINGLE-AGENT AND IN
COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH
ADVANCED SOLID TUMORS HARBORING MUTATIONS IN THE KRAS GENE
COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH
ADVANCED SOLID TUMORS HARBORING MUTATIONS IN THE KRAS GENE
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00116192
NCT ID
NCT06447662
Phase
I
Enrollment Status
Pending Open to Enrollment