A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

Phase 1RecruitingNCT07318805

Pfizer260 enrolled

Overview

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 that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC). All participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles. Depending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Advanced Breast Cancer Metastatic Breast Cancer (HR+/ HER2-)

Interventions

PF-08032562DRUG

Taken by mouth (PO)

FulvestrantDRUG

Selective Estrogen Receptor Degrader (SERD)

CetuximabDRUG

Monoclonal antibody (EGFR inhibitor)

FluorouracilDRUG

Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

OxaliplatinDRUG

Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)

LeucovorinDRUG

Part of FOLFOX chemotherapy regimen (folic acid analog)

BevacizumabDRUG

Monoclonal antibody (VEG-F inhibitor)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4/6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease * Measurable disease * ECOG performance status 0 or 1 Exclusion Criteria: * Active malignancy within 3 years prior to enrollment * Known symptomatic brain metastases requiring steroids * Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term * Prior irradiation to \>25% of the bone marrow * Hypertension that cannot be controlled by optimal medical therapy * Renal impairment * Hepatic dysfunction * Cardiac abnormalities * Active bleeding disorder * Active or history of clinically significant GI disease * Other unacceptable abnormalities as defined by protocol

Locations (3)

START Midwest, LLC

Grand Rapids, Michigan, United States

RECRUITING

START San Antonio

San Antonio, Texas, United States

NOT_YET_RECRUITING

START Mountain Region

West Valley City, Utah, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)

Any adverse events 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.

Time frame: Baseline up to 28 days

Part 1 (Dose Escalation): Number of participants with laboratory abnormalities

Number of participants with laboratory test abnormalities.

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

Part 1 (Dose Escalation): 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.

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

Part 2 (Dose Expansion): Objective Response Rate (ORR)

ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Time frame: 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

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

Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.

Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

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

Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.

Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)

Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.

Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

Part 1: Effect of Food on Cmax

Evaluate the effect of food on Cmax of PF-08032562 as monotherapy

Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

Part 1: Effect of Food on Tmax

Evaluate the effect of food on Tmax of PF-08032562 as monotherapy

Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

Part 1: Effect of Food on AUClast

Evaluate the effect of food on AUClast of PF-08032562 as monotherapy

Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

Part 1: Percent change of immune cells within tumors based on immunohistochemistry assessment

Evaluate the single and multiple dose pharmacodynamics of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. This measure will assess change in the concentration of immune cell-related cytokines and chemokines as potential pharmacodynamic effects of PF-08032562 using Immunohistochemistry (IHC) assays.

Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

Part 2 (Dose Expansion): Number of participants with laboratory abnormalities

Number of participants with laboratory test abnormalities.

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

Part 2 (Dose Expansion): 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.

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

Part 1 & Part 2: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

ORR is defined as the percentage of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1.

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

Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1

DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1.

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

Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1

CBR is defined as the percentage of participants with a best overall response of CR or PR at any time before Progressive Disease (PD), or non-CR/non-PD or SD for at least 24 weeks from start date of treatment and prior to PD, relative to the appropriate analysis set.

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

Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1

DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.

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

Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1

PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause.

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

Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1

TTR is defined as the time from start date of treatment to first documentation of CR or PR.

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

A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts