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

✅ This trial is currently recruiting volunteers

If you think you might be eligible, speak to your GP or specialist about this trial before applying.

Status

Recruiting

Phase

PHASE1

Participants

ALL

Age Range

18 Years+

About This Trial

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 in combination with endocrine therapy.

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.

The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant.

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 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 doses of PF-07220060 will be administered in combination with enzalutamide.

In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE.

Part 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060.

Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively.

Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy.

Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK.

The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.

Who Can Join?

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…

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