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Treatment of advanced cancers with Mevrometostat

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

PHASE1 · Pfizer · NCT03460977

This study is testing a new drug called Mevrometostat to see if it can help people with advanced cancers like small cell lung cancer, prostate cancer, and follicular lymphoma feel better and improve their treatment outcomes.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment453 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer (industry)
Locations82 sites (Tucson, Arizona and 81 other locations)
Trial IDNCT03460977 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates the safety and efficacy of Mevrometostat (PF-06821497) in patients with relapsed or refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC), and Follicular Lymphoma (FL). The study is designed as an open-label, multi-center trial that includes dose escalation and expansion phases, where Mevrometostat is administered either alone or in combination with standard of care treatments. The trial aims to determine the maximum tolerated dose (MTD) and assess the drug's antitumor activity across different patient cohorts, including those from Japan and China. Participants will be monitored for safety, pharmacokinetics, and treatment response.

Who should consider this trial

Good fit: Ideal candidates include adults with relapsed or refractory SCLC, CRPC, or FL who have previously received standard treatments and show evidence of disease progression.

Not a fit: Patients with early-stage cancers or those who have not yet received standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are resistant to current therapies.

How similar studies have performed: Other studies have shown promising results with similar approaches targeting EZH2 in various cancers, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Part 1 and Part 2 (Closed for enrollment).

Part 3 Key Inclusion Criteria:

* Histological or cytological diagnosis of castration resistant prostate cancer.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months.
* Adequate bone marrow, renal, and liver function

Part 3 Key Exclusion Criteria:

* Prior irradiation to \>25% of the bone marrow.
* QTcF interval \>480 msec at screening.
* Hypertension that cannot be controlled by medications (\>150/90 mmHg despite optimal medical therapy).
* Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)
* Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
* Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4/5 inducers or inhibitors
* Prior enzalutamide within the last 4 weeks
* DDI SUBSTUDY:
* history of CHF or evidence of ventricular dysfunction
* fructose intolerance
* coadministration of CYP3A4 substrates

Where this trial is running

Tucson, Arizona and 81 other locations

+32 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Castration Resistant Prostate Cancer, Small Cell Lung Cancer, Follicular Lymphoma, EZH2, enhancer of zeste homolog 2, castrate resistant prostate cancer, prostatecancer-study.com, mCRPC

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.