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

ConditionsAdvanced Breast CancerMetastatic Breast Cancer (HR+/ HER2-)Colorectal CancerMetastatic Colorectal AdenocarcinomaTriple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • PF-08032562

    Drug

    Taken by mouth (PO)

  • Fulvestrant

    Drug

    Selective Estrogen Receptor Degrader (SERD)

  • Cetuximab

    Drug

    Monoclonal antibody (EGFR inhibitor)

  • Fluorouracil

    Drug

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

  • Oxaliplatin

    Drug

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

  • Leucovorin

    Drug

    Part of FOLFOX chemotherapy regimen (folic acid analog)

  • Bevacizumab

    Drug

    Monoclonal antibody (VEG-F inhibitor)

Treatment groups

260 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part 1 Dose Escalation Cohort 1AExperimental treatment 1 intervention
Group B: Part 1 Dose Escalation Cohort 1BExperimental treatment 2 interventions
Group C: Part 1 Dose Escalation Cohort 1CExperimental treatment 2 interventions
Group D: Part 1 Dose Escalation Cohort 1DExperimental treatment 5 interventions
Group E: Part 2 Dose Expansion Cohort 2AExperimental treatment 2 interventions
Group F: Part 2 Dose Expansion Cohort 2BExperimental treatment 2 interventions
Group G: Part 2 Dose Expansion Cohort 2CExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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