PF-08046031 for Melanoma

Not currently recruiting at 15 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Taxanes, Vedotin, MMAE

Disqualifiers: Active cerebral disease, Uveal melanoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, PF-08046031, as a potential cancer treatment to assess its safety and identify any side effects in individuals with melanoma and other solid tumors lacking approved treatments or that have metastasized. The trial aims to determine the correct dosage and evaluate the drug's effectiveness against these cancers. It seeks participants with melanoma who have already undergone at least one type of immunotherapy and have no remaining standard treatment options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you stop certain treatments like chemotherapy, radiotherapy, biologics, and immunotherapy at least 4 weeks before starting the study drug. If your disease has progressed on treatment, you must stop these treatments at least 2 weeks before starting the study drug.

Is there any evidence suggesting that PF-08046031 is likely to be safe for humans?

Research has shown that PF-08046031 is an experimental drug tested for safety in people with melanoma and other solid tumors. Currently, clear information on how well people tolerate this treatment is lacking, as available research doesn't provide specific safety details. Since the study is in its first phase, the drug is still in early testing to assess its safety for humans. This phase typically involves checking for side effects and determining the right dose. Because it's early in the process, detailed safety information is still being collected. It's important to note that the drug has not yet been proven safe or effective for treating any condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PF-08046031 for melanoma because it introduces a novel approach by targeting specific pathways that current treatments may not address. Unlike traditional therapies like immunotherapy or targeted therapy with BRAF inhibitors, PF-08046031 might offer a unique mechanism of action that could potentially enhance efficacy or reduce side effects. This innovative approach provides hope for improved outcomes, particularly for patients who have limited responses to existing treatments.

What evidence suggests that PF-08046031 might be an effective treatment for melanoma?

Research has shown that PF-08046031, administered as monotherapy in this trial, has potential to fight melanoma in lab studies. Tests with mice demonstrated that this drug can shrink tumors containing the protein CD228. This protein often appears on melanoma cancer cells, making it a target for treatment. While these early results are promising, the drug is still under investigation for safety and effectiveness in humans. The researchers aim to determine if it can help treat melanoma and other hard-to-treat tumors. ^{1 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people with advanced melanoma or other solid tumors that have spread and don't respond to standard treatments. Participants must have tried at least one immunotherapy regimen and can't have more than two prior systemic therapies. They should be in good physical condition, as measured by an ECOG score of 0 or 1.

Inclusion Criteria

I am very active or have minor symptoms and my cancer can be measured by standard health scans.

I have advanced melanoma that didn't respond to initial immunotherapy.

I have advanced melanoma and my cancer progressed after 1-2 treatments including anti PD-1/PD-L1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Determine the appropriate dosage of PF-08046031 for participants

Approximately 6 months

Treatment Part B

Further dosage determination and safety assessment of PF-08046031

Approximately 6 months

Treatment Part C

Evaluate the safety and efficacy of PF-08046031 using information from Parts A and B

Approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• PF-08046031

Trial Overview The study tests the safety and effectiveness of a new drug called PF-08046031 for treating melanoma and other solid tumors. It has three parts: determining the right dose, optimizing it, and then expanding the trial to see if it's safe across different tumor types.

How Is the Trial Designed?

Group I: PF-08046031 monotherapy Experimental Treatment 1 Intervention

PF-08046031

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06799533

NCT06799533 | A Study to Learn About the ... This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment.

2. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/clinical_trial/NCT06799533

Clinical Trial Details | Pfizer Oncology Development Website AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS. Phase 1. NCT06799533. Active Not-enrolling.

3. webfiles.pfizer.com webfiles.pfizer.com/file/01jqh5eft19e7eaz9m2z9b6b65

PF-08046031: A Promising First-in- Class Antibody-Drug ... Figure 4: Antitumor activity of PF-08046031 was evaluated in two cell-line derived xenograft (CDX) melanoma models expressing CD228. Tumor-bearing mice with ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/skin-cancer-melanoma

UCSF Skin Cancer/Melanoma Clinical Trials for 2025 This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/34204655/pfizers-phase-1-study-on-pf-08046031-a-new-hope-for-advanced-melanoma-and-solid-tumors/

Pfizer's Phase 1 Study on PF-08046031: A New Hope for ... ' The study aims to evaluate the safety and side effects of PF-08046031, a drug intended for patients with advanced melanoma and other solid ...

6. trials.braintumor.org trials.braintumor.org/trials/NCT06799533

A Study to Learn About the Study Medicine Called PF ... This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment.

7. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/molecule/cd228v-directed-adc

CD228V directed Antibody Drug Conjugate CD228V directed Antibody Drug Conjugate. PF-08046031 | CD228V is an investigational compound. Its safety and efficacy have not been established. Go to section ...

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06799533

Learn About the Study Medicine Called PF-08046031 in ... This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or ...

9. trials.teamjackfoundation.org trials.teamjackfoundation.org/trials/NCT06799533

A Study to Learn About the Study Medicine Called PF-08046031 in ... ... PF-08046031 in Advanced Melanoma and Other Solid Tumors. Study Purpose. This study will test the safety of a drug called PF-08046031 ... safety data. Phase 3: ...