Active — Not RecruitingPhase 2

PF-07104091 as a Single Agent and in Combination Therapy

United States157 participantsStarted 2020-09-16

Plain-language summary

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy) * Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting * Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received at least 1 systemic anti-cancer therapy containing a platinum analog * Participants with cytological diagnosis of advanced/metastatic SCLC * Participants with or cytological diagnosis of advanced/metastatic NSCLC * Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven). * Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated * Performance Status 0 or 1 * Adequate bone marrow, hematological, kidney and liver function * Resolved acute effects of any prior therapy to baseline severity Exclusion Criteria: * Participants with known symptomatic brain metastases requiring steroids * Participants with any other active malignancy …

What they're measuring

Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

Timeframe: 28 days

To evaluate incidence of treatment emergent adverse events and laboratory abnormalities

Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)

Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline

Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)

Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline

Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)

To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline

Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)

To evaluate the preliminary antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose expansion

Timeframe: From baseline through disease progression or study completion (approximately 2 years)

Trial details

NCT IDNCT04553133

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

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