Clinical Trials /

Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

NCT04557449

Description:

This is a Phase 1, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D). In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). Part 1B and Part 1C may be enrolled and conducted in parallel at the completion of Part 1A.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Liposarcoma
  • Lung Adenocarcinoma
  • Malignant Solid Tumor
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
  • Official Title: A PHASE 1/1B 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

Clinical Trial IDs

  • ORG STUDY ID: C4391001
  • SECONDARY ID: 2020-002938-33
  • NCT ID: NCT04557449

Conditions

  • Liposarcoma
  • CRC
  • Prostate Cancer
  • Breast Neoplasms
  • Adenocarcinoma of Lung
  • Solid Tumors

Interventions

DrugSynonymsArms
PF-072200601B Combination Dose Finding Arm 1

Purpose

This is a Phase 1, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D). In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). Part 1B and Part 1C may be enrolled and conducted in parallel at the completion of Part 1A.

Trial Arms

NameTypeDescriptionInterventions
Monotherapy Escalation Arm 1ExperimentalPF-07220060 Monotherapy Escalation
  • PF-07220060
Monotherapy Escalation Arm 2ExperimentalPF-07220060 Monotherapy Escalation
  • PF-07220060
Monotherapy Escalation Arm 3ExperimentalPF-07220060 Monotherapy Escalation
  • PF-07220060
Monotherapy Escalation Arm 4ExperimentalPF-07220060 Monotherapy Escalation
  • PF-07220060
1B Combination Dose Finding Arm 1ExperimentalPF-07220060 with Letrozole combination Escalation
  • PF-07220060
1B Combination Dose Finding Arm 2ExperimentalPF-07220060 with Letrozole Combination Escalation
  • PF-07220060
1C Combination Dose Finding Arm 1ExperimentalPF-07220060 with Fulvestrant Combination Escalation
  • PF-07220060
1C Combination Dose Finding Arm 2ExperimentalPF-07220060 with Fulvestrant Combination Escalation
  • PF-07220060

Eligibility Criteria

        Inclusion Criteria

          -  Disease Characteristics - Breast Cancer (Part 1A, Part 1B and Part 1C)

          -  Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2
             Negative (HER2-) breast cancer (2L + with prior CDK 4/6) locally advance or metastatic
             breast cancer. Participants should have received at least 1 line of SOC, including
             CDK4/6 inhibitor therapy, or at least 1 line of anti-endocrine therapy in countries
             without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease

          -  Part 1A only: Refractory HR-positive (HR+), Human Epidermal Growth Factor Receptor 2
             Positive (HER2+) breast cancer

          -  Evaluable lesion (including skin or bone lesion only)

          -  Disease Characteristics - Part 1A: Tumors other than BC

          -  Participants with advanced or metastatic disease

          -  Participants with histological or cytological diagnosis of adenocarcinoma of NSCLC,
             prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1
             amplification according to local standard tests, that is resistant to at least 2 lines
             of standard systemic therapy for advanced or recurrent disease or for which no
             standard therapy is available

          -  Participants must not be eligible to undergo therapy with curative intent (surgery or
             radiation therapy with or without chemotherapy

        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:

          -  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

          -  Participation in other studies involving investigational drug(s) within 4 weeks prior
             to study entry

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with dose limiting toxicities in the Dose Escalation Portion
Time Frame:Baseline up to day 28 of Cycle 1.
Safety Issue:
Description:Adverse Events

Secondary Outcome Measures

Measure:Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
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
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero Extrapolated to Infinity (AUCinf) in the Dose Escalation and Dose Finding portion
Time Frame:Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion
Time Frame:Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Safety Issue:
Description:Pharmacokinetic (PK) assessments for PF-07220060
Measure:Tumor Response observed in participants in Dose Escalation and Dose Finding portion
Time Frame:baseline up to approximately 24 months
Safety Issue:
Description:
Measure:Duration of Response (DOR) in participants enrolled in the Dose Escalation and Dose Finding portion
Time Frame:baseline up to approximately 24 months
Safety Issue:
Description:
Measure:Progression Free Survival (PFS) observed in participants in the Dose Escalation and Dose Finding portion
Time Frame:baseline up to approximately 24 months
Safety Issue:
Description:
Measure:Time to Progression (TTP) observed in participants enrolled in the Dose Escalation and Dose Finding portion
Time Frame:baseline up to approximately 24 months
Safety Issue:
Description:
Measure:Overall Survival observed in participants enrolled in the Dose Expansion Arms
Time Frame:baseline up to approximately 24 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Pfizer

Last Updated

September 15, 2020