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Pfizer has made an internal business decision to not continue further development of PF-07260437. This decision was not due to major safety concerns or requests from any regulatory authorities.
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A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy dose escalation (Part 1) | Experimental | Participants will receive PF-07260437 |
|
| Dose Expansion (Part 2A) - Tumor specific Arm A | Experimental | Participants will receive PF-07260437 |
|
| Dose Expansion (Part 2B) - Tumor specific Arm B | Experimental | Participants will receive PF-07260437 |
|
| Dose Expansion (Part 2C) - Tumor specific Arm C | Experimental | Participants will receive PF07260437 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07260437 | Drug | B7-H4 x CD3 bi-specific mAb |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) in Dose Escalation - Part 1 | Any of the following treatment-related adverse events (AEs) occurring during the DLT observation period were classified as DLTs: Hematological DLTs: neutropenia Grade (G) 4, febrile neutropenia, ≥G3 for >7d (days), G3 with infection; thrombocytopenia G4, G3 with bleeding or requiring platelet transfusion; anemia G4, G3 requiring blood transfusion. Non-hematologic: hepatic toxicity; ≥G3 fatigue for ≥5d, ≥G3 nausea/vomiting or diarrhea for ≥3d, ≥G3 cytokine release syndrome (CRS) of any duration/QTcF prolongation/anaphylaxis, G5 AE without clear reason; immune-related (ir)AE: ≥G4 irAEs/colitis, G3/4 non-infectious pneumonitis, G2 pneumonitis not resolved to ≤G1 within 3d of the initiation of max supportive care. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of CRS, which were graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading for CRS. | The first dose of the study intervention (C1D1) through Day 28 for participants without a priming dose or through Day 42 for participants with a priming dose. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Part 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as any AE that occurred from first dose of study intervention to either last dose of study treatment + 90 days, start of new anti-cancer therapy, or completion in study as determined by disposition, whichever was earliest. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, or was a congenital anomaly/birth defect. AEs were graded by the investigator according to CTCAE v5.0. | Baseline (Day 1 of dosing ) through 4 week follow-up, up to 35.1 weeks |
| Number of Participants With Clinically Significant Laboratory Abnormalities - Part 1 | Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Immune-Related Adverse Events (irAEs) | irAEs included gastrointestinal (ie, diarrhea/colitis), dermatological (ie, rash), pulmonary (ie, pneumonitis), hepatic (ie, liver test elevation), renal (ie, creatinine increased), cardiac (ie, myocarditis), endocrine (ie, endocrine disorder), and other toxicities. | Day 1 up to 90 days after the last dose of study intervention (Day 246 [C9D15]), up to approximately 336 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte | California | 91010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42171881 | Derived | Yan F, Cruz-Correa M, Specht J, Wang EW, Lu J, Soliman H, Jackson-Fisher A, Tang SY, Jiang S, Le Corre C, Li M, Sommerhalder D. A phase 1 study of PF-07260437, a B7-H4 x CD3 bispecific T-cell engager, in patients with advanced or metastatic breast, ovarian, and endometrial cancer. Invest New Drugs. 2026 May 22. doi: 10.1007/s10637-026-01614-2. Online ahead of print. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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The decision to terminate the study was made on 27 July 2023, due to strategic reasons. By the time of study termination, Part 2 of the study has not been initiated. Therefore, only results from Part 1 are presented.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07260437 100 ug SC Q2W | Participants with locally advanced or metastatic breast cancer (BrCa), ovarian cancer (OvCa) or endometrial cancer received PF-07260437 100 microgram (ug) by subcutaneous (SC) injection every 2 weeks (Q2W) in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2021 | Oct 3, 2024 |
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|
| B7-H4 IHC | Diagnostic Test | B7-H4 expression |
|
| Baseline through up to 35.1 weeks |
| Number of Participants by Categories of Anti-Drug Antibody (ADA) Against PF-07260437 | Number of participants with positive ADA against PF-07257876 were summarized for each treatment arm. A participant had treatment-induced ADA response if he/she had negative or missing ADA at baseline and ≥1 post-treatment ADA positive titer. A participant had treatment-boosted ADA response if he/she had positive titer at baseline and a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample. | On Day 1 of Cycle 1, 2, 3. From Cycle 4 onwards: collection on Day 1 of every 3 cycles (C4D1, C7D1, etc.) until end-of-treatment visit, up to 35.1 weeks. |
| Single Dose: Maximal Concentration (Cmax) | Maximum observed serum concentration following single dose of PF-07260437. The multiple dose PK samples were not collected due to dose interruption or discontinuation. The PK sampling schedule was designed to evaluate the dosing interval of 2 weeks. Since the 100/300/800 group received the second dose (300 ug) only 1 week after the first dose. The PK parameters were not calculable. | Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1 |
| Single Dose: Area Under the Curve (AUCtau) | Area under the plasma concentration-time profile from time 0 to time tau (Ï„), the dosing interval following single dose of PF-07260437. The multiple dose PK samples were not collected due to dose interruption or discontinuation. The PK sampling schedule was designed to evaluate the dosing interval of 2 weeks. Since the 100/300/800 group received the second dose (300 ug) only 1 week after the first dose. The PK parameters were not calculable. | Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1 |
| Single Dose: Time to Maximal Plasma Concentration (Tmax) | Time to maximal plasma concentration following single dose of PF-07260437. The multiple dose PK samples were not collected due to dose interruption or discontinuation. The PK sampling schedule was designed to evaluate the dosing interval of 2 weeks. Since the 100/300/800 group received the second dose (300 ug) only 1 week after the first dose. The PK parameters were not calculable. | Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1 |
| Moffitt Cancer Center at McKinley Campus |
| Tampa |
| Florida |
| 33612 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | 60451 | United States |
| The University of Chicago Medicine Center of Advanced Care Orland Park | Orland Park | Illinois | 60462 | United States |
| Montefiore Einstein Center for Cancer Care | The Bronx | New York | 10461 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| Swedish Cancer Institute Edmonds Campus | Edmonds | Washington | 98026 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center - Mountlake | Seattle | Washington | 98195 | United States |
| Pan American Center for Oncology Trials, LLC | Rio Piedras | 00935 | Puerto Rico |
| Pan American Center for Oncology Trials- Hospital Oncologico | Rio Piedras | 00935 | Puerto Rico |
| Pan American Center for Oncology Trials | Rio Piedras | 00935 | Puerto Rico |
| FG001 |
| PF-07260437 300 ug SC Q2W |
Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 300 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| FG002 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| FG003 | PF-07260437 200 ug (Priming) + 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 (Cycle 1 Day 1) and full/maintenance dose of 500 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| FG004 | PF-07260437 200 ug (Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| FG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| FG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 1: Follow-up |
|
|
Baseline analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-07260437 100 ug SC Q2W | Participants with locally advanced or metastatic breast cancer (BrCa), ovarian cancer (OvCa) or endometrial cancer received PF-07260437 100 microgram (ug) by subcutaneous (SC) injection every 2 weeks (Q2W) in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| BG001 | PF-07260437 300 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 300 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| BG002 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| BG003 | PF-07260437 200 ug (Priming) + 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 (Cycle 1 Day 1) and full/maintenance dose of 500 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| BG004 | PF-07260437 200 ug (Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| BG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| BG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) in Dose Escalation - Part 1 | Any of the following treatment-related adverse events (AEs) occurring during the DLT observation period were classified as DLTs: Hematological DLTs: neutropenia Grade (G) 4, febrile neutropenia, ≥G3 for >7d (days), G3 with infection; thrombocytopenia G4, G3 with bleeding or requiring platelet transfusion; anemia G4, G3 requiring blood transfusion. Non-hematologic: hepatic toxicity; ≥G3 fatigue for ≥5d, ≥G3 nausea/vomiting or diarrhea for ≥3d, ≥G3 cytokine release syndrome (CRS) of any duration/QTcF prolongation/anaphylaxis, G5 AE without clear reason; immune-related (ir)AE: ≥G4 irAEs/colitis, G3/4 non-infectious pneumonitis, G2 pneumonitis not resolved to ≤G1 within 3d of the initiation of max supportive care. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of CRS, which were graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading for CRS. | DLT evaluable set included all enrolled participants who had at least 1 dose of study intervention and either experienced DLT or did not have major protocol deviations during the DLT observation period. | Posted | Count of Participants | Participants | The first dose of the study intervention (C1D1) through Day 28 for participants without a priming dose or through Day 42 for participants with a priming dose. |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Part 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as any AE that occurred from first dose of study intervention to either last dose of study treatment + 90 days, start of new anti-cancer therapy, or completion in study as determined by disposition, whichever was earliest. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, or was a congenital anomaly/birth defect. AEs were graded by the investigator according to CTCAE v5.0. | All enrolled participants who received at least one dose of study intervention were included in the analysis. | Posted | Count of Participants | Participants | Baseline (Day 1 of dosing ) through 4 week follow-up, up to 35.1 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities - Part 1 | Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion. | All enrolled participants who received at least one dose of study intervention were included in the analysis. | Posted | Count of Participants | Participants | Baseline through up to 35.1 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Immune-Related Adverse Events (irAEs) | irAEs included gastrointestinal (ie, diarrhea/colitis), dermatological (ie, rash), pulmonary (ie, pneumonitis), hepatic (ie, liver test elevation), renal (ie, creatinine increased), cardiac (ie, myocarditis), endocrine (ie, endocrine disorder), and other toxicities. | All enrolled participants who receive at least 1 dose of study intervention were included in the analysis. | Posted | Count of Participants | Participants | Day 1 up to 90 days after the last dose of study intervention (Day 246 [C9D15]), up to approximately 336 days |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Categories of Anti-Drug Antibody (ADA) Against PF-07260437 | Number of participants with positive ADA against PF-07257876 were summarized for each treatment arm. A participant had treatment-induced ADA response if he/she had negative or missing ADA at baseline and ≥1 post-treatment ADA positive titer. A participant had treatment-boosted ADA response if he/she had positive titer at baseline and a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample. | The immunogenicity analysis set included all enrolled participants who received at least 1 dose of study treatment and had at least 1 sample tested for ADA. | Posted | Count of Participants | Participants | On Day 1 of Cycle 1, 2, 3. From Cycle 4 onwards: collection on Day 1 of every 3 cycles (C4D1, C7D1, etc.) until end-of-treatment visit, up to 35.1 weeks. |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Single Dose: Maximal Concentration (Cmax) | Maximum observed serum concentration following single dose of PF-07260437. The multiple dose PK samples were not collected due to dose interruption or discontinuation. The PK sampling schedule was designed to evaluate the dosing interval of 2 weeks. Since the 100/300/800 group received the second dose (300 ug) only 1 week after the first dose. The PK parameters were not calculable. | All enrolled participants treated who did not have protocol deviations influencing PK assessment and had sufficient information to estimate at least 1 of the PK parameters of interest. Participants with ≤3 sampling points or missing PK samples on day 14 were excluded. Participants in 200/500, 200/800, 200/1600 groups received the same dose on Day 1, and therefore, were combined for single dose (200 ug) PK to increase the sample size and provide more confidence to the estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Single Dose: Area Under the Curve (AUCtau) | Area under the plasma concentration-time profile from time 0 to time tau (τ), the dosing interval following single dose of PF-07260437. The multiple dose PK samples were not collected due to dose interruption or discontinuation. The PK sampling schedule was designed to evaluate the dosing interval of 2 weeks. Since the 100/300/800 group received the second dose (300 ug) only 1 week after the first dose. The PK parameters were not calculable. | All enrolled participants treated who did not have protocol deviations influencing PK assessment and had sufficient information to estimate at least 1 of the PK parameters of interest. Participants with ≤3 sampling points or missing PK samples on day 14 were excluded. Participants in 200/500, 200/800, 200/1600 groups received the same dose on Day 1, and therefore, were combined for single dose (200 ug) PK to increase the sample size and provide more confidence to the estimate. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*day/mL | Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Single Dose: Time to Maximal Plasma Concentration (Tmax) | Time to maximal plasma concentration following single dose of PF-07260437. The multiple dose PK samples were not collected due to dose interruption or discontinuation. The PK sampling schedule was designed to evaluate the dosing interval of 2 weeks. Since the 100/300/800 group received the second dose (300 ug) only 1 week after the first dose. The PK parameters were not calculable. | All enrolled participants treated who did not have protocol deviations influencing PK assessment and had sufficient information to estimate at least 1 of the PK parameters of interest. Participants with ≤3 sampling points or missing PK samples on day 14 were excluded. Participants in 200/500, 200/800, 200/1600 groups received the same dose on Day 1, and therefore, were combined for single dose (200 ug) PK to increase the sample size and provide more confidence to the estimate. | Posted | Median | Full Range | days | Day 1 pre-dose, 1, 4, 8, 24, 48 and 168 hours post-dose, till Day 15 pre-dose in Cycle 1 |
|
Baseline through up to 35.1 weeks
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, or was a congenital anomaly/birth defect.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-07260437 100 ug SC Q2W | Participants with locally advanced or metastatic breast cancer (BrCa), ovarian cancer (OvCa) or endometrial cancer received PF-07260437 100 microgram (ug) by subcutaneous (SC) injection every 2 weeks (Q2W) in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. | 1 | 3 | 0 | 3 | 3 | 3 |
| EG001 | PF-07260437 300 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 300 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. | 3 | 4 | 2 | 4 | 4 | 4 |
| EG002 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. | 1 | 4 | 1 | 4 | 4 | 4 |
| EG003 | PF-07260437 200 ug (Priming) + 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 (Cycle 1 Day 1) and full/maintenance dose of 500 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. | 2 | 6 | 5 | 6 | 6 | 6 |
| EG004 | PF-07260437 200 ug (Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. | 1 | 4 | 1 | 4 | 4 | 4 |
| EG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. | 0 | 4 | 3 | 4 | 4 | 4 |
| EG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. | 1 | 5 | 2 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Anion gap increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Electrocardiogram ST-T segment abnormal | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Lung diffusion test decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Weight fluctuation | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
|
The decision to terminate the study was made on 27 Jul 2023, due to strategic reasons. The multiple dose PK samples were not collected due to dose interruption or discontinuation. By the time of study termination, Part 2 of the study has not been initiated. Therefore, no data have been collected for Part 2 and corresponding endpoints were not reported.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2021 | Oct 3, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
| Physician Decision |
|
| Death |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 300 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria.
| OG002 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG003 | PF-07260437 200 ug (Priming) + 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 (Cycle 1 Day 1) and full/maintenance dose of 500 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG004 | PF-07260437 200 ug (Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
|
|
| OG002 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG003 | PF-07260437 200 ug (Priming) + 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 (Cycle 1 Day 1) and full/maintenance dose of 500 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG004 | PF-07260437 200 ug (Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
|
|
Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG003 | PF-07260437 200 ug (Priming) + 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 (Cycle 1 Day 1) and full/maintenance dose of 500 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG004 | PF-07260437 200 ug (Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
|
|
| OG002 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG003 | PF-07260437 200 ug (Priming) + 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 (Cycle 1 Day 1) and full/maintenance dose of 500 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG004 | PF-07260437 200 ug (Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG005 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG006 | PF-07260437 200 ug (Priming) + 1600 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 priming dose of 200 ug on C1D1 and full/maintenance dose of 1600 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
|
|
The group of 200 ug dose includes participants who received an identical priming dose (200 ug) from 200/500, 200/800, and 200/1600 Q2W dose groups.
| OG002 | PF-07260437 300 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 300 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG003 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG004 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
|
|
The group of 200 ug dose includes participants who received an identical priming dose (200 ug) from 200/500, 200/800, and 200/1600 Q2W dose groups. |
| OG002 | PF-07260437 300 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 300 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG003 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG004 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
|
|
| OG002 | PF-07260437 300 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 300 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG003 | PF-07260437 500 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 500 ug by SC injection Q2W in 28-day cycles (on Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
| OG004 | PF-07260437 100 ug (First Priming) + 300 ug (Second Priming) + 800 ug SC Q2W | Participants with locally advanced or metastatic BrCa, OvCa or endometrial cancer received PF-07260437 first priming dose of 100 ug on C1D1, second priming dose of 300 ug on C1D8, and full/maintenance dose of 800 ug on C1D15 and afterwards by SC injection Q2W in 28-day cycles (Days 1 and 15) until the participant met one of the study intervention discontinuation criteria. |
|
|