Actively Recruiting
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-04
830
Participants Needed
74
Research Sites
427 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.
CONDITIONS
Official Title
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable disease by RECIST 1.1 criteria
- Adequate organ function
- Male participants agree to use contraception and avoid sperm donation unless azoospermic
- Female participants must not be pregnant or breastfeeding, agree to contraception, and have a negative pregnancy test before starting treatment
- Arm 1: Locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation and at least one prior systemic therapy
- Arm 2: Untreated metastatic non-small cell lung cancer with KRAS G12C mutation and PD-L1 tumor proportion score ≥1%
- Arm 3: Locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation and prior systemic therapy; includes subgroups with non-small cell lung cancer or other tumors excluding NSCLC or colorectal cancer
- Arm 4: Untreated advanced or metastatic nonsquamous non-small cell lung cancer with KRAS G12C mutation
- Arm 5: Locally advanced unresectable or metastatic colorectal adenocarcinoma with KRAS G12C mutation and prior systemic therapy failure
- Arm 6: Locally advanced unresectable or metastatic colorectal adenocarcinoma with KRAS G12C mutation
You will not qualify if you...
- Received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose
- History of second malignancy unless cured with no evidence for 5 years
- Clinically active central nervous system metastases or carcinomatous meningitis
- Active infection requiring systemic therapy
- Known HIV infection or active Hepatitis B or C infection
- History of interstitial lung disease, noninfectious pneumonitis needing steroids, or ongoing pneumonitis
- Active autoimmune disease requiring systemic therapy
- Not fully recovered from major surgery without infection
- Certain eye conditions including glaucoma or retinal diseases
- Received live or live-attenuated vaccine within 4 weeks before study start
- Arm 4 only: Unable to stop aspirin or other NSAIDs as required or unwilling to take folic acid, vitamin B12, and dexamethasone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 74 locations
1
Moffitt Cancer Center ( Site 0261)
Tampa, Florida, United States, 33612
Actively Recruiting
2
START Midwest ( Site 0267)
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
Laura and Isaac Perlmutter Cancer Center ( Site 0270)
New York, New York, United States, 10016
Completed
5
NEXT Virginia ( Site 0271)
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
7
Instituto Alexander Fleming ( Site 0434)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
8
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)
La Rioja, Argentina, F5300COE
Actively Recruiting
9
Chris O'Brien Lifehouse ( Site 0002)
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
10
Liverpool Hospital-Medical Oncology ( Site 0001)
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
11
Westmead Hospital ( Site 0006)
Westmead, New South Wales, Australia, 2145
Actively Recruiting
12
Monash Health-Oncology Research ( Site 0003)
Clayton, Victoria, Australia, 3168
Actively Recruiting
13
Cross Cancer Institute ( Site 0033)
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
14
The Moncton Hospital ( Site 0037)
Moncton, New Brunswick, Canada, E1C 6Z8
Actively Recruiting
15
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
16
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
17
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
18
James Lind Centro de Investigacion del Cancer ( Site 0043)
Temuco, Araucania, Chile, 4800827
Completed
19
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)
Santiago, Region M. de Santiago, Chile, 7500653
Actively Recruiting
20
FALP-UIDO ( Site 0040)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
21
Bradfordhill ( Site 0042)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
22
Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
23
Fujian Cancer Hospital ( Site 0419)
Fuzhou, Fujian, China, 350014
Actively Recruiting
24
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413)
Guangzhou, Guangdong, China, 510515
Actively Recruiting
25
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415)
Guangzhou, Guangdong, China, 511400
Actively Recruiting
26
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418)
Wuhan, Hubei, China, 430048
Actively Recruiting
27
Jilin Cancer Hospital-oncology department ( Site 0412)
Changchun, Jilin, China, 132000
Completed
28
Shanghai Chest Hospital-Oncology department ( Site 0410)
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
29
Shanghai East Hospital ( Site 0416)
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
30
Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
31
Odense Universitetshospital-Department of oncology ( Site 0421)
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
32
Rambam Health Care Campus-Oncology ( Site 0090)
Haifa, Israel, 3109601
Actively Recruiting
33
Shaare Zedek Medical Center-Oncology ( Site 0092)
Jerusalem, Israel, 9103102
Actively Recruiting
34
Hadassah Medical Center-Oncology ( Site 0094)
Jerusalem, Israel, 9112001
Actively Recruiting
35
Meir Medical Center. ( Site 0091)
Kfar Saba, Israel, 4428164
Actively Recruiting
36
Sheba Medical Center-ONCOLOGY ( Site 0093)
Ramat Gan, Israel, 5265601
Actively Recruiting
37
Humanitas ( Site 0113)
Rozzano, Lombardy, Italy, 20089
Actively Recruiting
38
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111)
Siena, Tuscany, Italy, 53100
Actively Recruiting
39
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)
Naples, Italy, 80131
Actively Recruiting
40
National Cancer Center Hospital East ( Site 0404)
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
41
Kanagawa Cancer Center ( Site 0402)
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
42
Shizuoka Cancer Center ( Site 0401)
Nakatogari, Shizuoka, Japan, 411-8777
Actively Recruiting
43
National Cancer Center Hospital ( Site 0403)
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
44
Cancer Institute Hospital of JFCR ( Site 0400)
Koto, Tokyo, Japan, 135-8550
Actively Recruiting
45
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 0121)
Kaunas, Kaunas County, Lithuania, 45433
Actively Recruiting
46
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0120)
Vilnius, Lithuania, LT-08406
Actively Recruiting
47
Sarawak General Hospital ( Site 0453)
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
48
New Zealand Clinical Research (Christchurch) ( Site 0004)
Christchurch, Canterbury, New Zealand, 8011
Completed
49
Centro Oncologico de Panama ( Site 0160)
Panama City, Panama, 082410
Actively Recruiting
50
Centro Hemato Oncológico Paitilla ( Site 0163)
Panama City, Panama, 0832-00752
Completed
51
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0172)
Poznan, Greater Poland Voivodeship, Poland, 60-569
Actively Recruiting
52
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0170)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
53
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0171)
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
54
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0173)
Koszalin, West Pomeranian Voivodeship, Poland, 75-581
Actively Recruiting
55
Seoul National University Hospital ( Site 0191)
Seoul, South Korea, 03080
Actively Recruiting
56
Samsung Medical Center-Division of Hematology/Oncology ( Site 0193)
Seoul, South Korea, 06351
Actively Recruiting
57
Clinica Universidad de Navarra ( Site 0213)
Madrid, Madrid, Comunidad de, Spain, 28027
Actively Recruiting
58
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0211)
Madrid, Madrid, Comunidad de, Spain, 28040
Actively Recruiting
59
Hospital Universitari Vall d'Hebron-Oncology ( Site 0212)
Barcelona, Spain, 08035
Actively Recruiting
60
Cantonal Hospital St.Gallen ( Site 0224)
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
61
Ospedale Regionale Bellinzona e Valli ( Site 0220)
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
62
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 0445)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
Actively Recruiting
63
National Cheng Kung University Hospital ( Site 0444)
Tainan, Taiwan, 704
Actively Recruiting
64
National Taiwan University Hospital-Oncology ( Site 0443)
Taipei, Taiwan, 10002
Actively Recruiting
65
Ege University Medicine of Faculty ( Site 0231)
Bornova, İzmir, Turkey (Türkiye), 35100
Completed
66
Erciyes University ( Site 0232)
Talas, Kayseri, Turkey (Türkiye), 38039
Completed
67
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0234)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
68
Ankara City Hospital-oncology ( Site 0233)
Ankara, Turkey (Türkiye), 6800
Actively Recruiting
69
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 0254)
Cherkasy, Cherkasy Oblast, Ukraine, 18009
Actively Recruiting
70
Communal Non-Commercial Enterprise Prykarpatski Clinical Onc-Chemotherapy department ( Site 0251)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
Actively Recruiting
71
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 0255)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
Actively Recruiting
72
Rivne Regional Clinical Hospital ( Site 0257)
Rivne, Rivne Oblast, Ukraine, 33007
Completed
73
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0259)
Rivne, Rivne Oblast, Ukraine, 33010
Actively Recruiting
74
Uzhhorod Multispecialty City Clinical Hospital ( Site 0258)
Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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