A Study to Learn About the Study Medicine PF-07985045 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Change in a Gene.

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Pfizer
Study ID
NCT06704724
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-07985045 — DRUG
    KRAS inhibitor
  • Gemcitabine — COMBINATION_PRODUCT
    Chemotherapy (antimetabolite)
  • Nab-paclitaxel — COMBINATION_PRODUCT
    Taxane-type Chemotherapy
  • Cetuximab — COMBINATION_PRODUCT
    Monoclonal Antibody (EGFR Inhibitor)
  • Fluorouracil — COMBINATION_PRODUCT
    Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
  • Oxaliplatin — COMBINATION_PRODUCT
    Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent)
  • Leucovorin — COMBINATION_PRODUCT
    Part of FOLFOX chemotherapy regimen Folic Acid Analog
  • Bevacizumab — COMBINATION_PRODUCT
    VEG-F inhibitor
  • Pembrolizumab — COMBINATION_PRODUCT
    immune checkpoint inhibitor (PD-1 inhibitor
  • Sasanlimab — COMBINATION_PRODUCT
    immune checkpoint inhibitor (PD-1 inhibitor)
  • pemetrexed — COMBINATION_PRODUCT
    Can be used in Platinum-based Chemotherapy regimen Antimetabolite
  • Cisplatin — COMBINATION_PRODUCT
    Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent)
  • Paclitaxel — COMBINATION_PRODUCT
    Can be used in Platinum-based chemotherapy regimen Taxane
  • Carboplatin — COMBINATION_PRODUCT
    Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent)
  • PF-07284892 — COMBINATION_PRODUCT
    PF-07284892 used as a combination product.

Study Details

The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication. 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-07985045) as pill by mouth. This will be repeated 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-07985045 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 different times (depending on the treatment) during the 21-day or 28-day cycle. Participants can continue to take the study medication (PF-07985045) 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 in this study for up to 4 years. During this time, the participants will come into the clinic for 1 to 4 times in each 21-day or 28-day cycle. After the participants 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

Key Dates

Start date
Dec 10, 2024
Status verified
May 2026
Primary completion
May 12, 2026
Completion
May 12, 2026

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation
    PF-07985045 monotherapy Dose Escalation at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 1 Cohort A1
    PF-07985045 monotherapy dose expansion in 2-3L PDAC at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 1 Cohort B1
    PF-07985045 monotherapy dose expansion in 2-3L CRC at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 1 Cohort C1
    PF-07985045 monotherapy dose expansion in 2-3L NSCLC at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 1 Cohort D1
    PF-07985045 monotherapy dose expansion in other tumor types at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2 Cohort A2
    Combination (PF-07985045 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2 Cohort B2
    Combination (PF-07985045 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2 Cohort B3
    Combination (PF-07985045 + FOLFOX + Bevacizumab) dose escalation/ expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2 Cohort B4
    Combination (PF-07985045 + FOLFOX + Cetuximab) dose escalation/ expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2 Cohort C2
    Combination (PF-07985045 + Pembro or sasanlimab) dose escalation/expansion in 1L NSCLC (TPS ≥ 50%) Prescribed dose and frequency in 21-day (pembro) or 28-day (sasanlimab) cycles
  • Experimental: Part 2 Cohort C3
    Combination (PF-07985045 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles
  • Experimental: Part 2 Cohort X
    Combination (PF-07985045 + PF-07284892) dose escalation/expansion Prescribed dose and frequency in 21-day cycles

Primary Outcome Measure

Part 1 & 2: Incidence of Adverse Events (AEs) [ Time Frame: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first) ]

Locations (12)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
Highlands Oncology GroupRogersArkansas72758-
Highlands Oncology GroupSpringdaleArkansas72762-
City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)DuarteCalifornia91010-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
DFCI Chestnut HillNewtonMassachusetts02467-
Columbia University Irving Medical CenterNew YorkNew York10032-
The Trustees of Columbia University and The New York and Presbyterian HospitalNew YorkNew York10032-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718-
University of Wisconsin Carbone Cancer Center-University HospitalMadisonWisconsin53792-

Find similar trials in Fayetteville, AR

By condition
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By specialty
OncologyGI oncology
By research site
Highlands Oncology Group· Fayetteville, ARHighlands Oncology Group· Rogers, ARHighlands Oncology Group· Springdale, ARCity of Hope (City of Hope National Medical Center, City Of Hope Medical Center)· Duarte, CABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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