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Carcinoma, Pancreatic DuctalPhase 1NCT06447662

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.

A Phase 1 study testing PF-07934040, Gemcitabine and Nab-paclitaxel in people with Carcinoma, Pancreatic Ductal and Colorectal Neoplasms, run by Pfizer at 27 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-07934040, Gemcitabine and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
27 sitesin 2 countries
Study dates
27 Jun 2024to 9 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor.
  • ECOG PS 0 or 1
  • Presence of at least 1 measurable lesion based on RECIST version 1.1 that has not been previously irradiated.
  • Documentation of mutated KRAS gene
  • PDAC, CRC, Other tumor types: Confirmed KRAS mutation, any variant
  • NSCLC: Confirmed KRAS mutation, any variant except previously treated G12C. If driver mutation, must have failed precision medicine therapy [eg, inhibitors of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), and others].
Show all 17Show fewer
  • Part 1 and Part 2a: Participant must have progressed on standard treatment(s) for which no additional, effective therapy is available.
  • PDAC (2-3L): Participants must have received and radiologically progressed on prior lines of systemic therapy for metastatic pancreatic adenocarcinoma. If participants received prior neoadjuvant or adjuvant chemotherapy and progressed within 6 months of the last dose, then this should be considered as a prior line of systemic therapy.
  • NSCLC (2-3L): Participants must have received prior lines of anti-cancer treatment and progressed on at least a platinum-containing chemotherapy regimen or ICI. Participants may have had only one or two prior lines of therapy in the advanced/metastatic setting. For participants with EGFR, ALK, or other genomic tumor alterations, participants must have progressed on approved therapy for these alterations.
  • CRC (2-3L): Participants must have had one or two prior lines of therapy for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, oxaliplatin, and/or irinotecan for one prior treatment, exposure to VEGF/VEGF receptor (VEGFR) inhibitor is optional;
  • Other tumors: Participants, in the judgment of the investigator, must have progressed or become intolerant to all available standard therapies, or have refused such therapy.
  • Part 2b:
  • PDAC (1L) Cohort A2: Participants must not have received prior chemotherapy for metastatic disease. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant treatment or neoadjuvant therapy, the participant would be considered 2L, and not 1L.
  • CRC (2-3L) Cohort B2: Participants must have had one or two prior systemic treatment regimens for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin; for one prior treatment, exposure to a VEGF/VEGF receptor (VEGFR) inhibitor is optional.
  • CRC (1L) Cohort B3/B4: Participants must not have received prior therapy for metastatic disease and not be a candidate for other targeted therapy or immunotherapy. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant or neoadjuvant therapy, then the participant would be considered 2L, and not 1L.
  • NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not have received prior systemic treatment setting.
  • NSCLC (1L) Cohort C3: Participants with any TPS and must not have received prior systemic treatment setting.

Who cannot join

  • Active or history of pneumonitis/ILD or pulmonary fibrosis requiring treatment with systemic steroid therapy.
  • Diagnosis of immunodeficiency or an active autoimmune disease that require systemic treatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy in the past 2 years.
  • Sensory peripheral neuropathy ≥Grade 2
  • Active or history of clinically significant gastrointestinal (GI) disease (including but not limited to inflammatory GI disease [eg, ulcerative colitis, Crohn's disease, inflammatory bowel disease], immune-mediated colitis, peptic ulcer disease, GI bleeding, chronic diarrhea) and other conditions that are unresolved and/or may increase the risk associated with study participation or study treatment administration.
  • Active bleeding disorder, including GI bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months.
  • Major surgery or completion of radiation therapy ≤4 weeks prior to enrollment/randomization or radiation therapy that included >30% of the bone marrow.
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  • Known sensitivity or contraindication to any component of study intervention (PF 07934040, gemcitabine, nab-paclitaxel, cetuximab, bevacizumab, FOLFOX, 5-FU, pembrolizumab, cisplatin, carboplatin, pemetrexed, SHP2 inhibitor(s), cyclin-dependent kinase (CDK) inhibitor(s), antibody drug conjugates (ADCs) or EGFR inhibitor(s)).
  • Hematologic abnormalities.
  • Renal impairment.
  • Hepatic abnormalities.

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States26 sites

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center - St Peters

    City of Saint Peters, Missouri, 63376

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

  • City of Hope Investigational Drug Service (IDS)

    Duarte, California, 91010

  • Duke University Medical Center, lnvestigational Chemotherapy Service

    Durham, North Carolina, 27710

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Highlands Oncology Group, PA

    Fayetteville, Arkansas, 72703

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031

  • START Midwest

    Grand Rapids, Michigan, 49546

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Highlands Oncology Group, PA

    Rogers, Arkansas, 72758

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Siteman Cancer Center

    St Louis, Missouri, 63108

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • West Chester Hospital

    West Chester, Ohio, 45069

Other trials in United States

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official 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

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:

Read more
  • 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.

Being tested
PF-07934040, Gemcitabine, Nab-paclitaxel, Cetuximab, Fluorouracil
Keywords
Carcinoma, Pancreatic Ductal, Carcinoma, Ductal, Pancreatic, Duct-Cell Carcinoma of the Pancreas, Duct-Cell Carcinoma, Pancreas, Ductal Carcinoma of the Pancreas, Pancreatic Duct Cell Carcinoma, Pancreatic Ductal Carcinoma, pancreatic ductal adenocarcinoma, PADC, Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal, Rectal Cancer, Colon Cancer, CRC, MSS CRC, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Rectal Neoplasms, Colonic Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07934040Drug

    Also called PF-4040

    panKRAS inhibitor

  • GemcitabineCombination product

    Also called Gemzar

    Chemotherapy (antimetabolite)

  • Nab-paclitaxelCombination product

    Also called Abraxane

    Taxane-type Chemotherapy

  • CetuximabCombination product

    Also called Erbitux

    Monoclonal Antibody (EGFR Inhibitor)

  • FluorouracilCombination product

    Also called 5-FU, 5-fluorouracil

    Part of FOLFOX chemotherapy regimen

    cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

  • OxaliplatinCombination product

    Also called Eloxatin

    Part of FOLFOX Chemotherapy Regimen

    platinum based compound (alkylating agent)

  • LeucovorinCombination product

    Also called Folinic Acid, Wellcovorin, calcium folinate, Leucovorin Calcium

    Part of FOLFOX chemotherapy regimen

    Folic Acid Analog

  • BevacizumabCombination product

    Also called Zirabev, Avastin

    VEG-F inhibitor

  • PembrolizumabCombination product

    Also called Pembro, Lambrolizumab, MK-3475, Keytruda

    immune checkpoint inhibitor (PD-1 inhibitor)

  • pemetrexedCombination product

    Also called Alimta

    Can be used in Platinum-based Chemotherapy regimen

    Antimetabolite

  • CisplatinCombination product

    Also called Platinol, Cisplatinum, neoplatin

    Can be used as part of Platinum-based chemotherapy regimen

    Platinum-based antineoplastic (alkylating agent)

  • PaclitaxelCombination product

    Also called Taxol, Onxol

    Can be used in Platinum-based chemotherapy regimen

    Taxane

  • CarboplatinCombination product

    Also called Paraplatin, Stricarb

    Can be used as part of a platinum-based chemotherapy regimen

    platinum containing compound (alkylating agent)

  • SasanlimabCombination product

    Also called PF-06081591

    immune checkpoint inhibitor (PD-1 inhibitor)

Study groups in NCT06447662
Study groupRoleWhat they receive
Part 1ExperimentalPF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040
Part 2a Cohort A1ExperimentalMonotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040
Part 2a Cohort B1ExperimentalMonotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040
Part 2a Cohort C1ExperimentalMonotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040
Part 2a Cohort D1ExperimentalMonotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040
Part 2b Cohort A2ExperimentalCombination (PF-07934040 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040; Combination Product: Gemcitabine; Combination Product: Nab-paclitaxel
Part 2b Cohort B2ExperimentalCombination (PF-07934040 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040; Combination Product: Cetuximab
Part 2b Cohort B3ExperimentalCombination (PF-07934040 + FOLFOX + Bevacizumab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040; Combination Product: Fluorouracil; Combination Product: Oxaliplatin; Combination Product: Leucovorin; Combination Product: Bevacizumab
Part 2b Cohort B4ExperimentalCombination (PF-07934040 + FOLFOX + Cetuximab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07934040; Combination Product: Cetuximab; Combination Product: Fluorouracil; Combination Product: Oxaliplatin; Combination Product: Leucovorin
Part 2b Cohort C2ExperimentalCombination (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)
Receives: Drug: PF-07934040; Combination Product: Pembrolizumab; Combination Product: Sasanlimab
Part 2b Cohort C3ExperimentalCombination (PF-07934040 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles
Receives: Drug: PF-07934040; Combination Product: Pembrolizumab; Combination Product: pemetrexed; Combination Product: Cisplatin; Combination Product: Paclitaxel; Combination Product: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 & 2: Incidence of Adverse Events (AEs)

    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.

    Measured: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)

  2. PART 1 & 2: Number of participants with laboratory abnormalities

    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).

    Measured: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

  3. Part 1: Number of participants with Dose-limiting toxicities (DLT)

    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

    Measured: Baseline up to 28 days

  4. Part 2: Objective Response - Number of Participants With Objective Response (alone or in combination)

    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.

    Measured: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'

Secondary outcomes (8)

  1. Part 1 & 2: Maximum Observed Serum Concentration (Cmax)

    Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.

    Measured: baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)

  2. Part 1& 2: Time to Reach Maximum Observed Serum Concentration (Tmax)

    Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)

  3. Part 1 & 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)

  4. Part 1 & 2: Changes in pERK levels

    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.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)

  5. Part 1: Objective Response - Number of Participants With Objective Response

    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).

    Measured: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years

  6. Part 1: Effect of Food on Cmax

    Evaluate the effect of food on Cmax of PF-07934040 as monotherapy.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days)

  7. Part 1: Effect of Food on Tmax

    Evaluate the effect of food on Tmax of PF-07934040 as monotherapy.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days)

  8. Part 1: Effect of Food on AUClast

    Evaluate the effect of food on AUClast of PF-07934040 as monotherapy.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start27 Jun 2024
  3. Primary completion9 Oct 2026 (estimated)
  4. Study completion9 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06447662
Sponsor's protocol ID
C5421001
Other IDs
NCT06447662
Status last verified
Oct 2026
First submitted
29 May 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07934040, Gemcitabine and Nab-paclitaxel in people with Carcinoma, Pancreatic Ductal and Colorectal Neoplasms, run by Pfizer at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06447662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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