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Carcinoma, Pancreatic DuctalPhase 1NCT06704724

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.

A Phase 1 study testing PF-07985045, Gemcitabine and Nab-paclitaxel in people with Carcinoma, Pancreatic Ductal and Colorectal Neoplasms, run by Pfizer at 13 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-07985045, Gemcitabine and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
13 sitesin 2 countries
Study dates
10 Dec 2024to 12 May 2026
Phase
Phase 1
Are there results?
None posted in the registry

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.
  • Note for PDAC: Only participants with the histologic type of adenocarcinoma of the pancreas are allowed to enroll. For PDAC, if loco-regional disease is present, must also have metastatic disease.
  • Note for NSCLC: If a driver mutation is present, the participant was resistant or intolerant of precision medicine therapy (eg, inhibitors of EGFR, ALK, ROS1, or others).
  • 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
Show all 18Show fewer
  • KRAS mutations of any variant except previously treated with any KRAS inhibitor
  • Part 1: 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 and/or checkpoint inhibitor therapy; 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 only one or two prior systemic treatment regimens for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, oxaliplatin, 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 2:
  • 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, as long as relapse did not occur within 6 months of completing these forms of adjuvant treatment. If so, the relapse within 6 months would be considered a line of 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: Participants must not have had prior chemotherapy for advanced or metastatic disease. Participant could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy, as long as relapse did not occur within 6 months of complete of adjuvant therapy. If so, the relapse within 6 months would be considered a line of therapy; 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 pneumonitis/ILD, pulmonary fibrosis requiring treatment with systemic steroid therapy. Additionally, participants in IO combinations (Cohorts C2 and C3) with history and/or active pneumonitis/ILD or pulmonary fibrosis requiring steroids are excluded from enrollment.
  • 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.
  • Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including drainage catheter placement, therapeutic thoracentesis or abdominal paracentesis) is eligible.
  • Current use or have received PPIs in the last seven days prior to starting study treatment.
Show all 10Show fewer
  • Known sensitivity or contraindication to any component of study intervention (PF-07985045, gemcitabine, nab-paclitaxel, cetuximab, bevacizumab, FOLFOX, 5-FU, pembrolizumab, sasanlimab, cisplatin, carboplatin, pemetrexed, SHP2 inhibitor(s).
  • Hematologic abnormalities.
  • Renal impairment.
  • Hepatic abnormalities.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States12 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

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

    Duarte, California, 91010

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

  • University of Wisconsin Carbone Cancer Center-University Hospital

    Madison, Wisconsin, 53792

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • The Trustees of Columbia University and The New York and Presbyterian Hospital

    New York, New York, 10032

  • DFCI Chestnut Hill

    Newton, Massachusetts, 02467

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

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-07985045 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

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.

Read more

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

Being tested
PF-07985045, 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, PDAC, 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-07985045Drug

    Also called PF-5045

    KRAS 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

  • SasanlimabCombination product

    Also called PF-06801591

    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)

  • PF-07284892Combination product

    Also called ARRY-558

    PF-07284892 used as a combination product.

Study groups in NCT06704724
Study groupRoleWhat they receive
Part 1 Dose EscalationExperimentalPF-07985045 monotherapy Dose Escalation at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045
Part 1 Cohort A1ExperimentalPF-07985045 monotherapy dose expansion in 2-3L PDAC at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045
Part 1 Cohort B1ExperimentalPF-07985045 monotherapy dose expansion in 2-3L CRC at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045
Part 1 Cohort C1ExperimentalPF-07985045 monotherapy dose expansion in 2-3L NSCLC at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045
Part 1 Cohort D1ExperimentalPF-07985045 monotherapy dose expansion in other tumor types at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045
Part 2 Cohort A2ExperimentalCombination (PF-07985045 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045; Combination Product: Gemcitabine; Combination Product: Nab-paclitaxel
Part 2 Cohort B2ExperimentalCombination (PF-07985045 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045; Combination Product: Cetuximab
Part 2 Cohort B3ExperimentalCombination (PF-07985045 + FOLFOX + Bevacizumab) dose escalation/ expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045; Combination Product: Fluorouracil; Combination Product: Oxaliplatin; Combination Product: Leucovorin; Combination Product: Bevacizumab
Part 2 Cohort B4ExperimentalCombination (PF-07985045 + FOLFOX + Cetuximab) dose escalation/ expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07985045; Combination Product: Cetuximab; Combination Product: Fluorouracil; Combination Product: Oxaliplatin; Combination Product: Leucovorin
Part 2 Cohort C2ExperimentalCombination (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
Receives: Drug: PF-07985045; Combination Product: Pembrolizumab; Combination Product: Sasanlimab
Part 2 Cohort C3ExperimentalCombination (PF-07985045 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles
Receives: Drug: PF-07985045; Combination Product: Pembrolizumab; Combination Product: pemetrexed; Combination Product: Cisplatin; Combination Product: Paclitaxel; Combination Product: Carboplatin
Part 2 Cohort XExperimentalCombination (PF-07985045 + PF-07284892) dose escalation/expansion Prescribed dose and frequency in 21-day cycles
Receives: Drug: PF-07985045; Combination Product: PF-07284892

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 & Part 2 (Dose Escalation Only): 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) 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 ofPF-07985045 as monotherapy, or in combination with other anti-tumor agents.

    Measured: baseline through end of Cycle 1 (All cycles are 28 days except Part 2 Cohort C2/C3 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-07985045 as monotherapy, or in combination with other anti-tumor agents.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days except part 2 Cohort C2/C3 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-07985045 as monotherapy, or in combination with other anti-tumor agents.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days except Part 2 Cohort C2/C3 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-07985045 in peripheral blood of participants with advanced solid tumor malignancies.

    Measured: Baseline through end of Cycle 1 (All cycles are 28 days except Part 2 Cohort C2/C3 which are 21 days)

  5. 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) (Part 1 only), progression free survival (PFS), and duration of response (DOR).

    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-07985045 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-07985045 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-07985045 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 posted26 Nov 2024
  2. Study start10 Dec 2024
  3. Primary completion12 May 2026
  4. Study completion12 May 2026

Why it stopped: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06704724
Sponsor's protocol ID
C6081001
Other IDs
2024-517988-23-00
Status last verified
May 2026
First submitted
21 Nov 2024
Last updated
22 May 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-07985045, Gemcitabine and Nab-paclitaxel in people with Carcinoma, Pancreatic Ductal and Colorectal Neoplasms, run by Pfizer at 13 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 18 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: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

The study was stopped early (reason given: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.). Results are not available in the source record.

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 NCT06704724.

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 22 May 2026.

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