The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML. The duration of this multi-phase study is approximately 8 years.
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About the trial
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b). Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have: * a solid tumor which is metastatic or recurrent (excluding colorectal cancer) * tumor with the mutation (abnormal gene) called "BRAF V600" * received required prior treatment for cancer per cohort assigned. All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day. Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdiagnozowany zaawansowany guz lity, który się rozprzestrzenił lub nawrócił (z wyjątkiem raka jelita grubego).
- •Guz posiada specyficzną zmianę genetyczną (mutację) zwaną "BRAF V600".
- •Pacjent otrzymał wcześniej zalecane leczenie na raka.
- •Zmierzalna obecność choroby zgodnie z określonymi kryteriami.
- •Wymagana prawidłowa czynność narządów zgodnie z zasadami badania.
✗ Disqualifies
- •Inny aktywny nowotwór zdiagnozowany w ciągu ostatnich 3 lat.
- •Obecność choroby opon mózgowo-rdzeniowych.
- •Problemy z siatkówką oka (np. zakrzepica żył siatkówki) lub choroby zwyrodnieniowe siatkówki.
- •Choroby mięśni i nerwów związane z podwyższonym poziomem enzymu CK.
Simplified criteria — AI translation
Trial details
- Minimum age
- 16 Years
- Last updated (source)
- September 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (66)
The Kirklin Clinic of UAB Hospital
Birmingham, United States
The University of Alabama at Birmingham
Birmingham, United States
University of Alabama at Birmingham - Phase I Clinical Trials Unit
Birmingham, United States
Highlands Oncology Group, PA
Fayetteville, United States
Highlands Oncology Group, PA
Rogers, United States
Highlands Oncology Group, PA
Springdale, United States
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
Los Angeles, United States
Keck Hospital of USC
Los Angeles, United States
Los Angeles General Medical Center
Los Angeles, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, United States
Keck Medical Center of USC Pasadena
Pasadena, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, United States
UCSF Medical Center, Investigational Pharmacy
San Francisco, United States
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, United States
Moffitt Cancer Center
Tampa, United States
Moffitt McKinley Hospital
Tampa, United States
Ochsner Clinic Foundation
New Orleans, United States
Brigham and Women's Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
Brigitte Harris Cancer Pavilion
Detroit, United States
Henry Ford Hospital
Detroit, United States
MSK Basking Ridge.
Basking Ridge, United States
MSK Monmouth.
Middletown, United States
MSK Bergen.
Montvale, United States
MSK Commack.
Commack, United States
MSK Westchester.
Harrison, United States
Memorial Sloan Kettering Cancer Center 53rd street.
New York, United States
Columbia University Irving Medical Center
New York, United States
Columbia University Medical Center - Neurological Institute of New York
New York, United States
CUIMC Research Pharmacy
New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, United States
MSK Nassau.
Uniondale, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, United States
Providence Cancer Institute Franz Clinic
Portland, United States
Providence Portland Medical Center
Portland, United States
SCRI Oncology Partners
Nashville, United States
University of Texas MD Anderson Cancer Center
Houston, United States
Fred Hutchinson Cancer Center
Seattle, United States
University of Washington Medical Center
Seattle, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, United States
Peter MacCallum Cancer Centre
Melbourne, Australia
The Alfred Hospital
Melbourne, Australia
Royal Melbourne Hospital
Parkville, Australia
ANIMI - Unidade de Tratamento Oncologico
Lages, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, Brazil
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, Brazil
Cross Cancer Institute
Edmonton, Canada
Alberta Health Services and The Governors of The University of Alberta
Edmonton, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
Sunnybrook Research Institute
Toronto, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Jewish General Hospital
Montreal, Canada
McGill University Health Centre
Montreal, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Canada
Zhejiang Cancer Hospital
Hangzhou, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Hadassah Medical Center
Jerusalem, Israel
Soroka Medical Center
Beersheba, Israel
National Cancer Center Hospital East
Kashiwa, Japan
Kansai Medical University Hospital
Hirakata, Japan
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.
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