A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Pancreatic Ductal
• Colorectal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-07934040 — DRUG
  panKRAS 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)
• 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)
• Sasanlimab — COMBINATION_PRODUCT
  immune checkpoint inhibitor (PD-1 inhibitor)

Study Details

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.

Key Dates

Start date

Jun 27, 2024

Status verified

Apr 2026

Primary completion

Jan 19, 2028

Completion

Jan 18, 2029

Study Design

Enrollment

330 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles
• Experimental: Part 2a Cohort A1
  Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles
• Experimental: Part 2a Cohort B1
  Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles
• Experimental: Part 2a Cohort C1
  Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles
• Experimental: Part 2a Cohort D1
  Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles
• Experimental: Part 2b Cohort A2
  Combination (PF-07934040 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles
• Experimental: Part 2b Cohort B2
  Combination (PF-07934040 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles
• Experimental: Part 2b Cohort B3
  Combination (PF-07934040 + FOLFOX + Bevacizumab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
• Experimental: Part 2b Cohort B4
  Combination (PF-07934040 + FOLFOX + Cetuximab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
• Experimental: Part 2b Cohort C2
  Combination (PF-07934040 + Pembro or Sasanlimab) dose escalation/expansion in 1L NSCLC (TPS ≥ 50%) Prescribed dose and frequency in 21-day cycles (for pembro) or 28-day cycles (for sasanlimab)
• Experimental: Part 2b Cohort C3
  Combination (PF-07934040 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) 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) ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (26)

Find similar trials in Fayetteville, AR

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