~127 spots leftby Feb 2028

PF-07985045 for Cancer

Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Pfizer
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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 once a day. 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

Eligibility Criteria

This trial is for adults with advanced solid tumors like lung, colorectal, or pancreatic cancer that have grown despite treatment and have a specific DNA change in the KRAS gene. Participants should be relatively healthy (ECOG PS 0 or 1), have at least one measurable tumor not treated by radiation before, and must not have been effectively treated by certain targeted therapies if they carry specific mutations.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.
My pancreatic cancer is adenocarcinoma and has spread beyond the pancreas.
My NSCLC has a mutation and did not respond well to targeted therapy.
See 7 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07985045 alone or in combination with other anti-cancer therapies in 21-day or 28-day cycles

Up to 2 years
1 to 4 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • PF-07985045 (Monoclonal Antibodies)
Trial OverviewThe study tests PF-07985045 alone or with other anti-cancer drugs (like Paclitaxel, Carboplatin) to find the safest and most effective dose. It's given orally daily in cycles of 21 or 28 days. Other drugs may be administered intravenously during these cycles until there's no response from the cancer.
Participant Groups
11Treatment groups
Experimental Treatment
Group I: Part 2 Cohort XExperimental Treatment2 Interventions
Combination (PF-07985045 + SHP2) dose escalation/expansion Prescribed dose and frequency in 21-day cycles
Group II: Part 2 Cohort C3Experimental Treatment6 Interventions
Combination (PF-07985045 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles
Group III: Part 2 Cohort C2Experimental Treatment3 Interventions
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
Group IV: Part 2 Cohort B3Experimental Treatment5 Interventions
Combination (PF-07985045 + FOLFOX + Bevacizumab) dose escalation/ expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
Group V: Part 2 Cohort B2Experimental Treatment2 Interventions
Combination (PF-07985045 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles
Group VI: Part 2 Cohort A2Experimental Treatment3 Interventions
Combination (PF-07985045 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles
Group VII: Part 1 Dose EscalationExperimental Treatment1 Intervention
PF-07985045 monotherapy Dose Escalation at prescribed dose and frequency in 28-day cycles
Group VIII: Part 1 Cohort D1Experimental Treatment1 Intervention
PF-07985045 monotherapy dose expansion in other tumor types at prescribed dose and frequency in 28-day cycles
Group IX: Part 1 Cohort C1Experimental Treatment1 Intervention
PF-07985045 monotherapy dose expansion in 2-3L NSCLC at prescribed dose and frequency in 28-day cycles
Group X: Part 1 Cohort B1Experimental Treatment1 Intervention
PF-07985045 monotherapy dose expansion in 2-3L CRC at prescribed dose and frequency in 28-day cycles
Group XI: Part 1 Cohort A1Experimental Treatment1 Intervention
PF-07985045 monotherapy dose expansion in 2-3L PDAC at prescribed dose and frequency in 28-day cycles

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)Duarte, CA
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Who Is Running the Clinical Trial?

PfizerLead Sponsor

References