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.

NCT ID: NCT06704724

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2029-03-11

Brief 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.

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 Dose Escalation

PF-07985045 monotherapy Dose Escalation at prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Part 1 Cohort A1

PF-07985045 monotherapy dose expansion in 2-3L PDAC at prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Part 1 Cohort B1

PF-07985045 monotherapy dose expansion in 2-3L CRC at prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Part 1 Cohort C1

PF-07985045 monotherapy dose expansion in 2-3L NSCLC at prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Part 1 Cohort D1

PF-07985045 monotherapy dose expansion in other tumor types at prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Part 2 Cohort A2

Combination (PF-07985045 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC.

Prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Gemcitabine

Intervention Type: COMBINATION_PRODUCT

Chemotherapy (antimetabolite)

Nab-paclitaxel

Intervention Type: COMBINATION_PRODUCT

Taxane-type Chemotherapy

Part 2 Cohort B2

Combination (PF-07985045 + Cetuximab) dose escalation/expansion in 2-3L CRC

Prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Cetuximab

Intervention Type: COMBINATION_PRODUCT

Monoclonal Antibody (EGFR Inhibitor)

Part 2 Cohort B3

Combination (PF-07985045 + FOLFOX + Bevacizumab) dose escalation/ expansion in 1L CRC

Prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Fluorouracil

Intervention Type: COMBINATION_PRODUCT

Part of FOLFOX chemotherapy regimen

cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

Oxaliplatin

Intervention Type: COMBINATION_PRODUCT

Part of FOLFOX Chemotherapy Regimen

platinum based compound (alkylating agent)

Leucovorin

Intervention Type: COMBINATION_PRODUCT

Part of FOLFOX chemotherapy regimen

Folic Acid Analog

Bevacizumab

Intervention Type: COMBINATION_PRODUCT

VEG-F inhibitor

Part 2 Cohort B4

Combination (PF-07985045 + FOLFOX + Cetuximab) dose escalation/ expansion in 1L CRC

Prescribed dose and frequency in 28-day cycles

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Cetuximab

Intervention Type: COMBINATION_PRODUCT

Monoclonal Antibody (EGFR Inhibitor)

Fluorouracil

Intervention Type: COMBINATION_PRODUCT

Part of FOLFOX chemotherapy regimen

cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

Oxaliplatin

Intervention Type: COMBINATION_PRODUCT

Part of FOLFOX Chemotherapy Regimen

platinum based compound (alkylating agent)

Leucovorin

Intervention Type: COMBINATION_PRODUCT

Part of FOLFOX chemotherapy regimen

Folic Acid Analog

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

Group Type: EXPERIMENTAL

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Pembrolizumab

Intervention Type: COMBINATION_PRODUCT

immune checkpoint inhibitor (PD-1 inhibitor

Sasanlimab

Intervention Type: COMBINATION_PRODUCT

immune checkpoint inhibitor (PD-1 inhibitor)

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

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: COMBINATION_PRODUCT

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

platinum containing compound (alkylating agent)

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Pembrolizumab

Intervention Type: COMBINATION_PRODUCT

immune checkpoint inhibitor (PD-1 inhibitor

pemetrexed

Intervention Type: COMBINATION_PRODUCT

Can be used in Platinum-based Chemotherapy regimen

Antimetabolite

Cisplatin

Intervention Type: COMBINATION_PRODUCT

Can be used as part of Platinum-based chemotherapy regimen

Platinum-based antineoplastic (alkylating agent)

Paclitaxel

Intervention Type: COMBINATION_PRODUCT

Can be used in Platinum-based chemotherapy regimen

Taxane

Part 2 Cohort X

Combination (PF-07985045 + PF-07284892) dose escalation/expansion

Prescribed dose and frequency in 21-day cycles

Group Type: EXPERIMENTAL

PF-07284892

Intervention Type: COMBINATION_PRODUCT

PF-07284892 used as a combination product.

PF-07985045

Intervention Type: DRUG

KRAS inhibitor

Interventions

Carboplatin

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

platinum containing compound (alkylating agent)

Intervention Type: COMBINATION_PRODUCT

PF-07284892

PF-07284892 used as a combination product.

Intervention Type: COMBINATION_PRODUCT

PF-07985045

KRAS inhibitor

Intervention Type: DRUG

Gemcitabine

Chemotherapy (antimetabolite)

Intervention Type: COMBINATION_PRODUCT

Nab-paclitaxel

Taxane-type Chemotherapy

Intervention Type: COMBINATION_PRODUCT

Cetuximab

Monoclonal Antibody (EGFR Inhibitor)

Intervention Type: COMBINATION_PRODUCT

Fluorouracil

Part of FOLFOX chemotherapy regimen

cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

Intervention Type: COMBINATION_PRODUCT

Oxaliplatin

Part of FOLFOX Chemotherapy Regimen

platinum based compound (alkylating agent)

Intervention Type: COMBINATION_PRODUCT

Leucovorin

Part of FOLFOX chemotherapy regimen

Folic Acid Analog

Intervention Type: COMBINATION_PRODUCT

Bevacizumab

VEG-F inhibitor

Intervention Type: COMBINATION_PRODUCT

Pembrolizumab

immune checkpoint inhibitor (PD-1 inhibitor

Intervention Type: COMBINATION_PRODUCT

Sasanlimab

immune checkpoint inhibitor (PD-1 inhibitor)

Intervention Type: COMBINATION_PRODUCT

pemetrexed

Can be used in Platinum-based Chemotherapy regimen

Antimetabolite

Intervention Type: COMBINATION_PRODUCT

Cisplatin

Can be used as part of Platinum-based chemotherapy regimen

Platinum-based antineoplastic (alkylating agent)

Intervention Type: COMBINATION_PRODUCT

Paclitaxel

Can be used in Platinum-based chemotherapy regimen

Taxane

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

PF-5045; Gemzar; Abraxane; Erbitux; 5-FU; 5-fluorouracil; Eloxatin; Folinic Acid; Wellcovorin; calcium folinate; Leucovorin Calcium; Zirabev; Avastin; Pembro; Lambrolizumab; MK-3475; Keytruda; PF-06801591; Alimta; Platinol; Cisplatinum; neoplatin; Taxol; Onxol; Paraplatin; Stricarb; ARRY-558

Eligibility Criteria

Inclusion Criteria

• 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

a. 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.

1. 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.

2. 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.

3. 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.

4. 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:

1. 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.

2. 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.

3. 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.

4. NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not have received prior systemic treatment setting.

5. NSCLC (1L) Cohort C3: Participants with any TPS and must not have received prior systemic treatment setting.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Highlands Oncology Group

Fayetteville, Arkansas, United States

Highlands Oncology Group

Rogers, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

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

Duarte, California, United States

City of Hope Investigational Drug Service (IDS)

Duarte, California, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

DFCI Chestnut Hill

Newton, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States

CUMC Research Pharmacy

New York, New York, United States

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

New York, New York, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Board of Regents of the University of Wisconsin System

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center-University Hospital

Madison, Wisconsin, United States

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

Pan American Center for Oncology Trials, LLC

Rio Piedras, , Puerto Rico

Countries

United States; Japan; Puerto Rico

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C6081001

To obtain contact information for a study center near you, click here.

Other Identifiers

2024-517988-23-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C6081001

Identifier Type: -

Identifier Source: org_study_id