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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

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Category

Breast Cancer

Atirmociclib | PF-07220060

Atirmociclib | PF-07220060 is an investigational compound. Its safety and efficacy have not been established.

A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Phase 1 /2

NCT04557449

Active enrolling

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Locations

United States, Argentina, China, Czechia, Japan, Mexico, Slovakia, United Kingdom

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Study design
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 1

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 2

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 3

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 4

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 5

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1B Combination Dose Finding Arm 1

PF-07220060 with Letrozole combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1B Combination Dose Finding Arm 2

PF-07220060 with Letrozole Combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1C Combination Dose Finding Arm 1

PF-07220060 with Fulvestrant Combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1C Combination Dose Finding Arm 2

PF-07220060 with Fulvestrant Combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1D Monotherapy Food Effect

PF-07220060 Monotherapy Food Effect

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

OTHER: 1E DDI Cohort

PF-07220060 DDI with Midazolam

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor

OTHER: Midazolam

Benzodiazepine
Participant Group/Arm

EXPERIMENTAL: 1F Combination Dose Finding

PF-07220060 with Enzalutamide Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1G Combination Dose Finding Arm 1

PF-07220060 with Tamoxifen Combination De-Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2A Combination Dose Expansion

PF-07220060 with fulvestrant combination expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2B Combination Dose Expansion

PF-07220060 with Letrozole Combination Expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2C Combination Dose Expansion

PF-07220060 with fulvestrant Combination Expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2E Combination Dose Expansion

PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2F Combination Dose Expansion

PF-07220060 with Tamoxifen Combination Expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: Giredestrant Combination Cohort (Group A)

PF-07220060 with Giredestrant Combination

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: Giredestrant Combination Cohort (Group B)

PF-07220060 with Giredestrant Combination

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
Inclusion Criteria * Part 1: Breast Cancer (BC) * Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC * Part 1A/Part 1D/Part 1E also include: Refractory HR-positive/HER2-positive BC * Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests * Part 1F: prostate cancer * Part 1G: HR-positive/HER2-negative BC * Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC * Part 1D: metastatic castration resistant prostate cancer * Giredestrant Combination Cohort: ER-positive/HER2-negative BC * Prior systemic Treatment * Part 1: HR-positive/HER2-negative BC * At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator * HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy * Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available * Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed * Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC * Part 2C: * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or * Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal * One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy * Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy * Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy General Inclusion Criteria * All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Adequate renal, liver, and bone marrow function
Exclusion criteria
* Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor * Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway * Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease * Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation within 4 weeks prior to study intervention * Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4 * Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry * Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis * Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate \<50 bpm at screening * Pregnant or breastfeeding female participant * Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Key dates
Study start date
  • September 2020
Estimated Study Completion Date
  • October 2029
Key endpoints
Primary Outcome Measures
Outcome Measure

Number of participants with dose limiting toxicities in the Dose Escalation or De-escalation Portion

Measure Description

First cycle (28 days) dose limiting toxicities

Time Frame

At the end of Cycle 1 (each cycle is 28 days)

Outcome Measure

Incidence of clinically significant AEs

Measure Description

Adverse Events

Time Frame

Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

Outcome Measure

Incidence of clinically significant laboratory assessments

Measure Description

safety laboratory abnormalities

Time Frame

Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

Outcome Measure

Incidence of clinically significant abnormal vital and ECG parameters

Measure Description

vital signs and heart rate corrected QT interval

Time Frame

Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

Outcome Measure

Maximal Plasma Concentration (Cmax) of PF-07220060 given with and without food

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Time to Maximum Plasma Concentration (Tmax) of PF-07220060 given with and without food

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point (AUClast) of PF-07220060 given with and without food

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Maximal Plasma Concentration (Cmax) of Midazolam with and without PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Time to Maximum Plasma Concentration (Tmax) of Midazolam with and without PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Timepoint (AUClast) of Midazolam with and without PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Maximal Concentration (Cmax,ss) of PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Time to Maximum Plasma Concentration (Tmax,ss) of PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Minimum Plasma Concentration (Cmin,ss) of PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Maximal Concentration (Cmax,ss) of Giredestrant

Measure Description

Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Time to Maximum Plasma Concentration (Tmax,ss) of Giredestrant

Measure Description

Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of Giredestrant

Measure Description

Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Steady State Minimum Plasma Concentration (Cmin,ss) of Giredestrant

Measure Description

Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days)

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Single Dose: Maximal Plasma Concentration (Cmax) in the Dose Escalation and Dose Finding portion

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1F)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1F)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1F)

Time Frame

Cycle 1 (each cycle is 28 days)

Outcome Measure

Multiple Dose: Steady State Maximal Concentration (Cmax,ss) in the Dose Escalation and Dose Finding portion

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

Time Frame

Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

Outcome Measure

Multiple Dose: Steady State Time to Maximum Plasma Concentration (Tmax,ss) in the Dose Escalation and Dose Finding portion

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

Time Frame

Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

Outcome Measure

Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCt,ss) in the Dose Escalation and Dose Finding portion

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

Time Frame

Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

Outcome Measure

Multiple Dose: Steady State Minimum Plasma Concentration (Cmin,ss) in the Dose Escalation and Dose Finding portion

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

Time Frame

Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

Outcome Measure

Steady State Peak Concentration of Enzalutamide and N-desmethyl Enzalutamide

Measure Description

Pharmacokinetic (PK) assessments for enzalutamide (Part 1F)

Time Frame

Cycles 1 - 12 (each cycle is 28 days)

Outcome Measure

Steady State Trough Concentration of Enzalutamide and N-desmethyl Enzalutamide

Measure Description

Pharmacokinetic (PK) assessments for enzalutamide (Part 1F)

Time Frame

Cycle 3 (each cycle is 28 days)

Outcome Measure

Tumor Response per RECIST v1.1 and per PCGW3

Measure Description

Per RECIST v1.1 (all cohorts except for Part 1F); per PCWG3 (Part 1F)

Time Frame

baseline up to approximately 24 months

Outcome Measure

Duration of Response (DOR)

Measure Description

Per RECIST v1.1

Time Frame

baseline up to approximately 24 months

Outcome Measure

Progression Free Survival (PFS)

Measure Description

PFS per RECIST v.1.1

Time Frame

baseline up to approximately 24 months

Outcome Measure

Clinical Benefit Rate (CBR)

Measure Description

CBR per RECIST v1.1

Time Frame

baseline up to approximately 24 months

Outcome Measure

PSA50

Measure Description

Part 1F

Time Frame

Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

Outcome Measure

Incidence of clinically significant AEs

Measure Description

Adverse Events (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

Outcome Measure

Incidence of clinically significant laboratory assessments

Measure Description

Safety laboratory abnormalities (Giredestrant Combination Cohort)

Time Frame

Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

Outcome Measure

Steady State Minimal Concentration (Cmin,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen

Measure Description

Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)

Time Frame

Cycle 2 (each cycle is 28 days)

Outcome Measure

Metabolite to Parent Ratio of Minimal Concentration (MRCmin) of 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen

Measure Description

Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)

Time Frame

Cycle 2 (each cycle is 28 days)

Outcome Measure

Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCt,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen

Measure Description

Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)

Time Frame

Cycle 2 (each cycle is 28 days)

Outcome Measure

Steady State Peak Concentration of PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Part 2A, 2B, 2C, 2E, 2F)

Time Frame

Cycle 1 (each cycle is 28 days) for Part 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F

Outcome Measure

Steady State Trough Concentration of PF-07220060

Measure Description

Pharmacokinetic (PK) assessments for PF-07220060 (Parts 2A, 2B, 2C, 2E, 2F)

Time Frame

Cycle 1 (each cycle is 28 days) for Parts 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F

Secondary Outcome Measures table for Clinical Trial
Number of participants

430

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of October 21st 2026.

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When calling, please reference this study number:

More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT04557449