PF-07934040
DrugpanKRAS inhibitor
Other names: PF-4040
NCT Number: NCT06447662
The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose.
This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that:
* are advanced (cancer that doesn't disappear or stay away with treatment) and * have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers).
This includes (but limited to) the following cancer types:
Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body.
Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control.
Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels.
All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles.
Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle.
Participants can continue to take the study medication (PF-07934040) and the combination anti-cancer therapy until their cancer is no longer responding.
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.
Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Pan American Center for Oncology Trials, LLC, Rio Piedras, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ECOG PS 0 or 1
Exclusion criteria
panKRAS inhibitor
Other names: PF-4040
Chemotherapy (antimetabolite)
Other names: Gemzar
Taxane-type Chemotherapy
Other names: Abraxane
Monoclonal Antibody (EGFR Inhibitor)
Other names: Erbitux
Part of FOLFOX chemotherapy regimen
cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
Other names: 5-FU, 5-fluorouracil
Part of FOLFOX Chemotherapy Regimen
platinum based compound (alkylating agent)
Other names: Eloxatin
Part of FOLFOX chemotherapy regimen
Folic Acid Analog
Other names: Folinic Acid, Wellcovorin, calcium folinate, Leucovorin Calcium
VEG-F inhibitor
Other names: Zirabev, Avastin
immune checkpoint inhibitor (PD-1 inhibitor)
Other names: Pembro, Lambrolizumab, MK-3475, Keytruda
Can be used in Platinum-based Chemotherapy regimen
Antimetabolite
Other names: Alimta
Can be used as part of Platinum-based chemotherapy regimen
Platinum-based antineoplastic (alkylating agent)
Other names: Platinol, Cisplatinum, neoplatin
Can be used in Platinum-based chemotherapy regimen
Taxane
Other names: Taxol, Onxol
Can be used as part of a platinum-based chemotherapy regimen
platinum containing compound (alkylating agent)
Other names: Paraplatin, Stricarb
immune checkpoint inhibitor (PD-1 inhibitor)
Other names: PF-06081591
Time frame: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.
Time frame: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).
Time frame: Baseline up to 28 days
Any of the prespecified AEs that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes
Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'
Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for overall response rate (ORR), progression free survival (PFS), and overall survivor (OS) assessed by the Investigator.
Time frame: baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.
Time frame: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.
Time frame: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.
Time frame: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Evaluates the intended mechanism of action (MoA) modulation of KRAS inhibition and target engagement effect of PF-07934040 in peripheral blood of participants with advanced solid tumor malignancies.
Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years
Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator including overall response rate (ORR), progression free survival (PFS), and overall survival (OS).
Time frame: Baseline through end of Cycle 1 (All cycles are 28 days)
Evaluate the effect of food on Cmax of PF-07934040 as monotherapy.
Time frame: Baseline through end of Cycle 1 (All cycles are 28 days)
Evaluate the effect of food on Tmax of PF-07934040 as monotherapy.
Time frame: Baseline through end of Cycle 1 (All cycles are 28 days)
Evaluate the effect of food on AUClast of PF-07934040 as monotherapy.
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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