A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors

Who is this study for? Patients with KRASG12C mutant advanced solid tumors
What treatments are being studied? MK-1084
Status: Recruiting
Location: See all (71) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a study evaluating the safety, pharmacokinetics, and efficacy of MK-1084 alone, and MK-1084 plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ For all participants:

• Has measurable disease by RECIST 1.1 criteria

• Has adequate organ function

• Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic

• Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention

⁃ For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease

⁃ For Arm 2

⁃ \- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%

⁃ For Arm 3

• Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC

• Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample

• Previous treatment failure of at least 1 line of systemic therapy Expansion Group B

• Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease

⁃ Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation

⁃ Arm 5 only

• Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation

• Previous treatment failure of one or 2 previous line(s) of systemic therapy

⁃ Arm 6 only

⁃ \- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation

Locations
United States
Florida
Moffitt Cancer Center ( Site 0261)
RECRUITING
Tampa
Michigan
START Midwest ( Site 0267)
RECRUITING
Grand Rapids
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
RECRUITING
Hackensack
New York
Laura and Isaac Perlmutter Cancer Center ( Site 0270)
COMPLETED
New York
Virginia
NEXT Virginia ( Site 0271)
RECRUITING
Fairfax
Wisconsin
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
RECRUITING
Milwaukee
Other Locations
Australia
Chris O'Brien Lifehouse ( Site 0002)
RECRUITING
Camperdown
Monash Health-Oncology Research ( Site 0003)
RECRUITING
Clayton
Liverpool Hospital-Medical Oncology ( Site 0001)
RECRUITING
Liverpool
Westmead Hospital ( Site 0006)
RECRUITING
Westmead
Canada
Cross Cancer Institute ( Site 0033)
RECRUITING
Edmonton
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)
RECRUITING
Hamilton
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)
RECRUITING
Kingston
The Moncton Hospital ( Site 0037)
RECRUITING
Moncton
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)
RECRUITING
Toronto
Chile
Bradfordhill ( Site 0042)
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)
RECRUITING
Santiago
FALP-UIDO ( Site 0040)
RECRUITING
Santiago
James Lind Centro de Investigacion del Cancer ( Site 0043)
COMPLETED
Temuco
China
Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)
RECRUITING
Beijing
Jilin Cancer Hospital-oncology department ( Site 0412)
COMPLETED
Changchun
Fujian Cancer Hospital ( Site 0419)
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413)
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415)
RECRUITING
Guangzhou
Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)
RECRUITING
Hangzhou
Shanghai Chest Hospital-Oncology department ( Site 0410)
RECRUITING
Shanghai
Shanghai East Hospital ( Site 0416)
RECRUITING
Shanghai
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418)
RECRUITING
Wuhan
Denmark
Odense Universitetshospital-Department of oncology ( Site 0421)
RECRUITING
Odense
Israel
Rambam Health Care Campus-Oncology ( Site 0090)
RECRUITING
Haifa
Hadassah Medical Center-Oncology ( Site 0094)
RECRUITING
Jerusalem
Shaare Zedek Medical Center-Oncology ( Site 0092)
RECRUITING
Jerusalem
Meir Medical Center. ( Site 0091)
RECRUITING
Kfar Saba
Sheba Medical Center-ONCOLOGY ( Site 0093)
RECRUITING
Ramat Gan
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)
RECRUITING
Napoli
Humanitas ( Site 0113)
RECRUITING
Rozzano
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111)
RECRUITING
Siena
Japan
National Cancer Center Hospital ( Site 0403)
RECRUITING
Chuo-ku
National Cancer Center Hospital East ( Site 0404)
RECRUITING
Kashiwa
Cancer Institute Hospital of JFCR ( Site 0400)
RECRUITING
Koto
Shizuoka Cancer Center ( Site 0401)
RECRUITING
Nakatogari
Kanagawa Cancer Center ( Site 0402)
RECRUITING
Yokohama
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 0121)
RECRUITING
Kaunas
Malaysia
Sarawak General Hospital ( Site 0453)
RECRUITING
Kuching
New Zealand
New Zealand Clinical Research (Christchurch) ( Site 0004)
COMPLETED
Christchurch
Panama
Centro Hemato Oncológico Paitilla ( Site 0163)
COMPLETED
Panama City
Centro Oncologico de Panama ( Site 0160)
RECRUITING
Panama City
Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0171)
RECRUITING
Gdansk
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0173)
RECRUITING
Koszalin
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0172)
RECRUITING
Poznan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0170)
RECRUITING
Warsaw
Republic of Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 0193)
RECRUITING
Seoul
Seoul National University Hospital ( Site 0191)
RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 0212)
RECRUITING
Barcelona
Clinica Universidad de Navarra ( Site 0213)
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0211)
RECRUITING
Madrid
Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0220)
RECRUITING
Bellinzona
Cantonal Hospital St.Gallen ( Site 0224)
RECRUITING
Sankt Gallen
Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 0445)
RECRUITING
Kaohsiung Niao Sung Dist
National Cheng Kung University Hospital ( Site 0444)
RECRUITING
Tainan City
National Taiwan University Hospital-Oncology ( Site 0443)
RECRUITING
Taipei
Turkey
Ankara City Hospital-oncology ( Site 0233)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0234)
RECRUITING
Ankara
Ege University Medicine of Faculty ( Site 0231)
COMPLETED
Bornova
Erciyes University ( Site 0232)
COMPLETED
Talas
Ukraine
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 0254)
RECRUITING
Cherkasy
Communal Non-Commercial Enterprise Prykarpatski Clinical Onc-Chemotherapy department ( Site 0251)
RECRUITING
Ivano-frankivsk
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 0255)
RECRUITING
Kropyvnytskyi
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0259)
RECRUITING
Rivne
Rivne Regional Clinical Hospital ( Site 0257)
COMPLETED
Rivne
Uzhhorod Multispecialty City Clinical Hospital ( Site 0258)
RECRUITING
Uzhhorod
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2021-12-17
Estimated Completion Date: 2030-02-25
Participants
Target number of participants: 830
Treatments
Experimental: Arm 1
Participants will receive daily oral escalating doses of up to 800 mg of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
Experimental: Arm 2
Participants will receive MK-1084 daily oral escalating dose of up to 800 mg plus pembrolizumab given as a 200 mg intravenous infusion once every 21-day cycle up to a total of 35 cycles (up to \~24 months). Treatment with MK-1084 will continue until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
Experimental: Arm 3
Participants will receive alternate formulation of MK-1084 until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
Experimental: Arm 4
Participants will receive MK-1084 daily oral dose plus an intravenous infusion of pembrolizumab (200 mg) once every 21-day cycle for up to 35 cycles (up to \~24 months). Participants will also receive carboplatin (per label) and pemetrexed (per label) once every 21-day cycle for the first 4 cycles.
Experimental: Arm 5
Participants will receive MK-1084 daily oral dose plus an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle.
Experimental: Arm 6
Participants will receive MK-1084 daily oral dose. Additionally, participants receive an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle, oxaliplatin (per label) for first 6 cycles, and leucovorin (per label) and 5-fluorouracil (per label) once every 14-days.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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