Actively Recruiting
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Led by PMV Pharmaceuticals, Inc · Updated on 2026-03-12
300
Participants Needed
76
Research Sites
374 weeks
Total Duration
On this page
Sponsors
P
PMV Pharmaceuticals, Inc
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.
CONDITIONS
Official Title
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old or 12 to 17 years old with Safety Review Committee approval
- Have a locally advanced or metastatic solid tumor with a TP53 Y220C mutation
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Previously treated with one or more anticancer therapies and have progressive disease
- Have adequate organ function
- Have measurable disease per RECIST v1.1 (Phase 2 only)
- For Phase 1b combination therapy, must be anti-PD-1/PD-L1 naive or have progressed on such treatment
- Have measurable disease (Phase 1b combination therapy)
You will not qualify if you...
- Received anticancer therapy within 21 days (or 5 half-lives) before study drug
- Received radiotherapy within 14 days before study drug
- Have a primary central nervous system tumor
- History of leptomeningeal disease or spinal cord compression
- Have brain metastases unless neurologically stable and not requiring steroids
- Stroke or transient ischemic attack within 6 months before screening
- Certain heart conditions within 6 months before screening, including unstable angina, heart attack, uncontrolled hypertension, congestive heart failure, QT prolongation, or rhythm abnormalities
- Use of strong CYP3A4 inhibitors or CYP2C9 inducers within 14 days before first dose
- History of gastrointestinal disease affecting drug absorption or inability to take oral medication
- History of prior organ transplant
- Active malignancy except treated cervical intraepithelial neoplasia or non-melanoma skin cancer
- Active uncontrolled Hepatitis B, Hepatitis C, or HIV infection
- Known KRAS mutation (Phase 2 only)
- Prior therapy with anti-PD-1/PD-L1/PD-L2 or other T-cell receptor agents discontinued due to severe immune-related adverse event (Phase 1b combination)
- Received live or live-attenuated vaccine within 30 days before first dose (Phase 1b combination)
- Immunodeficiency or chronic systemic steroid therapy within 7 days before first dose (Phase 1b combination)
- Severe hypersensitivity to pembrolizumab or its components (Phase 1b combination)
- Active autoimmune disease requiring systemic treatment in past 2 years (Phase 1b combination)
- History of radiation pneumonitis or active pneumonitis/interstitial lung disease requiring steroids (Phase 1b combination)
- Active infection requiring systemic therapy (Phase 1b combination)
- Known history of HIV infection (Phase 1b combination)
- Previous treatment with rezatapopt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 76 locations
1
University of California Irvine Chao Family Comprehensive Cancer Center
Irvine, California, United States, 92868
Actively Recruiting
2
University of San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Not Yet Recruiting
3
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90024
Actively Recruiting
4
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
Actively Recruiting
6
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
7
Medical Oncology Hematology Consultants
Newark, Delaware, United States, 19713
Actively Recruiting
8
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
9
Advent Health
Orlando, Florida, United States, 32803
Not Yet Recruiting
10
Florida Cancer Specialists South
Port Charlotte, Florida, United States, 33980
Actively Recruiting
11
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
12
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
13
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
14
Columbia University
New York, New York, United States, 10032
Not Yet Recruiting
15
Memorial Sloan Kettering
New York, New York, United States, 10065
Actively Recruiting
16
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
17
The Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
18
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
19
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97210
Actively Recruiting
20
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
21
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
22
WellSpan York Cancer Center
York, Pennsylvania, United States, 17403
Actively Recruiting
23
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Terminated
24
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
New Experimental Therapeutics - NEXT Oncology
Austin, Texas, United States, 78705
Actively Recruiting
26
UTSW - Moody Outpatient Center - Parkland Health
Dallas, Texas, United States, 75235
Not Yet Recruiting
27
UT Southwest Simmons Cancer Center
Dallas, Texas, United States, 75390
Actively Recruiting
28
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
29
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
30
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
31
University of Washington, Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
32
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
33
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, Australia
Actively Recruiting
34
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
Actively Recruiting
35
Flinders Medical Center
Bedford Park, South Australia, Australia
Actively Recruiting
36
Monash Medical Centre
Clayton, Victoria, Australia
Actively Recruiting
37
Linear Clinical Research
Nedlands, Western Australia, Australia
Actively Recruiting
38
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, Bas-Rhin, France
Actively Recruiting
39
Institut Bergonie
Bordeaux, Gironde, France
Actively Recruiting
40
Institut Claudius Regaud
Toulouse, Haute-Garonne, France
Actively Recruiting
41
EDOG Institut de Cancerologie de l'Ouest
Saint-Herblain, Loire-Atlantique, France
Actively Recruiting
42
Centre Jean Perrin
Clermont-Ferrand, Puy-de-Dôme, France
Actively Recruiting
43
Institut Gustave Roussy
Villejuif, Val-de-Marne, France
Actively Recruiting
44
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer
Lyon, France
Actively Recruiting
45
CHU de Nîmes
Nîmes, France, 30900
Actively Recruiting
46
Institute Cancer De Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
47
Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Actively Recruiting
48
Universitätsklinikum Augsburg
Augsburg, Bavaria, Germany
Actively Recruiting
49
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, Germany
Actively Recruiting
50
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Withdrawn
51
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Actively Recruiting
52
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Actively Recruiting
53
Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena
Rome, Lazio, Italy
Actively Recruiting
54
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Actively Recruiting
55
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Lombardy, Italy
Actively Recruiting
56
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Actively Recruiting
57
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Actively Recruiting
58
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo, Torino, Italy
Actively Recruiting
59
Humanitas San Pio X
Milan, Italy
Actively Recruiting
60
IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
61
National University Hospital
Kent Ridge, Singapore
Actively Recruiting
62
National Cancer Center of Singapore
Singapore, Singapore, 168582
Actively Recruiting
63
Asan Medical Center
Seoul, South Korea
Actively Recruiting
64
National Cancer Center
Seoul, South Korea
Actively Recruiting
65
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
66
Seoul University Hospital
Seoul, South Korea
Actively Recruiting
67
Severance Hospital Yonsei University
Seoul, South Korea
Actively Recruiting
68
START MADRID_Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, Spain
Actively Recruiting
69
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC
Madrid, Madrid, Spain
Actively Recruiting
70
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON
Barcelona, Spain
Actively Recruiting
71
NEXT Oncology-Hospital Quironsalud Barcelona
Barcelona, Spain
Actively Recruiting
72
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
73
START Rioja
Rioja, Spain
Actively Recruiting
74
Hospital Clinico Universitario de Valencia
Valencia, Spain
Actively Recruiting
75
Sarah Cannon Research Institute UK
London, Middlesex, United Kingdom
Actively Recruiting
76
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Actively Recruiting
Research Team
P
PMV Pharma Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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