Midazolam / Letrozole / Liposarcoma · Phase 2 Trial

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

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 1/2A trial registry record for PF-07220060, an investigational agent being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with advanced solid tumors. No results are reported in this registry entry; the study is actively recruiting across multiple dose-escalation and dose-expansion cohorts, alone and in combination with endocrine therapies or enzalutamide.

What was studied

Phase 2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Liposarcoma, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung; age from 18 Years. Intervention: 1A Monotherapy Escalation Arm 1; 1A Monotherapy Escalation Arm 2; 1A Monotherapy Escalation Arm 3; 1A Monotherapy Escalation Arm 4; 1B Combination Dose Finding Arm 1; 1B Combination Dose Finding Arm 2; 1C Combination Dose Finding Arm 1; 1C…. Compared with: PF-07220060 monotherapy versus PF-07220060 plus fulvestrant combination therapy in Part 2E; otherwise single-arm dose escalation and expansion cohorts.. n = 362. 39 sites across 8 countries.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This registry record indicates an ongoing early-phase trial with no posted results. Clinicians should await completion and publication of safety and tolerability data before considering PF-07220060 for clinical use.

Plain-language summary

This is a Phase 1/2A open-label, non-randomized safety and tolerability study of an investigational agent; no results are reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Number of participants with dose limiting toxicities in the Dose Escalation Portion (assessed at Baseline up to day 28 of Cycle 1.); Incidence of clinically significant AEs (assessed at Weekly during Cycle 1 and 2 and then every 28 days through study completion, up…); Incidence of clinically significant laboratory assessments (assessed at Weekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days thro…); Incidence of clinically significant abnormal vital and ECG parameters (assessed at Day 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and the…

DesignPhase 2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose

PopulationLiposarcoma, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung; age from 18 Years

Sample size362

Intervention1A Monotherapy Escalation Arm 1; 1A Monotherapy Escalation Arm 2; 1A Monotherapy Escalation Arm 3; 1A Monotherapy Escalation Arm 4; 1B Combination Dose Finding Arm 1; 1B Combination Dose Finding Arm 2; 1C Combination Dose Finding Arm 1; 1C…

ComparatorPF-07220060 monotherapy versus PF-07220060 plus fulvestrant combination therapy in Part 2E; otherwise single-arm dose escalation and expansion cohorts.

Setting39 sites across 8 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment362

Study phasePhase 1/2A

Primary outcome measure 1Number of participants with dose limiting toxicities in Dose Escalation Portion, baseline up to day 28 of Cycle 1

Primary outcome measure 2Incidence of clinically significant adverse events, weekly during Cycles 1–2, then every 28 days through study completion, up to approximately 24 months

Primary outcome measure 3Incidence of clinically significant laboratory assessments, weekly during Cycles 1–2, then every 28 days through study completion, up to approximately 24 months

Primary outcome measure 4Incidence of clinically significant abnormal vital and ECG parameters, day 1, 8, 15 of Cycle 1 and every 28 days from Cycle 2 through study completion, up to approximately 24 months

Clinical bottom line

Caveats

No trial results are reported in this registry record; enrollment is ongoing.
Open-label, non-randomized design limits ability to assess comparative efficacy.
Multiple study arms and dose cohorts complicate interpretation of a single primary endpoint.
Recruitment status is 'ACTIVE_NOT_RECRUITING,' but results summary is not available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1/2A open-label, non-randomized, multicenter dose escalation and expansion study.

Directness

moderate

Safety and tolerability endpoints are direct; efficacy outcomes not stated as primary measures.

Consistency

insufficient

Registry record only; no results reported for consistency assessment.

Risk of bias

limited

Open-label design without randomization or blinding increases risk of bias.

Sample adequacy

moderate

Planned enrollment 362 participants across multiple cohorts and dose levels.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04557449). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 362 participants (ACTUAL). Conditions: Liposarcoma, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung. Interventions: DRUG: PF-07220060; COMBINATION_PRODUCT: Letrozole; COMBINATION_PRODUCT: Fulvestrant; DRUG: Midazolam; COMBINATION_PRODUCT: Enzalutamide. Primary outcome measures: Number of participants with dose limiting toxicities in the Dose Escalation Portion , Baseline up to day 28 of Cycle 1.; Incidence of clinically significant AEs , Weekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days; Incidence of clinically significant laboratory assessments , Weekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months; Incidence of clinically significant abnormal vital and ECG parameters , Day 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and then every 28 days through study completion, up to approximately 24 months (Each cycle is 28 days); Food Effect , Day -7 through the end of Cycle 1; DDI , D1 to the end of Cycle 1. Brief summary: This is a Phase 1/2A, 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. The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A. Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC. Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively. Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants. The Japan monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as a single agent in Japanese participants.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

MidazolamNCT04557449LetrozoleLiposarcomaBreast NeoplasmsFulvestrantPfizerPF-07220060Prostate Cancer