Advanced Solid TumorsPhase 1KANDLELIT-001NCT05067283
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
A Phase 1 study testing Calderasib, Pembrolizumab and carboplatin in people with Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 75 sites in 21 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Calderasib, Pembrolizumab and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 75 sitesin 21 countries
- Study dates
- 17 Dec 2021to 25 Feb 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 histological 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
Who cannot join
- Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention
- Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
- Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active infection requiring systemic therapy
- Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
- Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
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- Has an active autoimmune disease requiring systemic therapy
- Has not fully recovered from any effects of major surgical procedure without significant detectable infection
- Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease excluding age-related macular degeneration
- Has received live or live-attenuated vaccine within 4 weeks of study start
- Arm 4 Only
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
- Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
Trial locations and contacts
75 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
75 sites in 21 countries
China9 sites, 8 recruiting
- Recruiting
Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)
Beijing, Beijing Municipality, 100050
Study Coordinator, 01063138585
- Completed
Jilin Cancer Hospital-oncology department ( Site 0412)
Changchun, Jilin, 132000
- Recruiting
Fujian Cancer Hospital ( Site 0419)
Fuzhou, Fujian, 350014
Study Coordinator, 0591-62752500
- Recruiting
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413)
Guangzhou, Guangdong, 510515
Study Coordinator, 8620 62787110
- Recruiting
Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415)
Guangzhou, Guangdong, 511400
Study Coordinator, 86 02087343801
- Recruiting
Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411)
Hangzhou, Zhejiang, 310022
Study Coordinator, 0571-88122092
- Recruiting
Shanghai Chest Hospital-Oncology department ( Site 0410)
Shanghai, Shanghai Municipality, 200030
Study Coordinator, 021-22200000
- Recruiting
Shanghai East Hospital ( Site 0416)
Shanghai, Shanghai Municipality, 200120
Study Coordinator, +86 13764694939
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418)
Wuhan, Hubei, 430048
Study Coordinator, 027-85726685
United States6 sites, 5 recruiting
- Recruiting
NEXT Virginia ( Site 0271)
Fairfax, Virginia, 22031
Study Coordinator, 703-280-5390
- Recruiting
START Midwest ( Site 0267)
Grand Rapids, Michigan, 49546
Study Coordinator, 616-954-5554
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
Hackensack, New Jersey, 07601
Study Coordinator, 551-996-5900
- Recruiting
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
Milwaukee, Wisconsin, 53226
Study Coordinator, 414-805-0505
- Completed
Laura and Isaac Perlmutter Cancer Center ( Site 0270)
New York, New York, 10016
- Recruiting
Moffitt Cancer Center ( Site 0261)
Tampa, Florida, 33612
Study Coordinator, 813-745-5995
Ukraine6 sites, 5 recruiting
- Recruiting
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 0254)
Cherkasy, Cherkasy Oblast, 18009
Study Coordinator, +380472370123
- Recruiting
Communal Non-Commercial Enterprise Prykarpatski Clinical Onc-Chemotherapy department ( Site 0251)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Study Coordinator, +380502094000
- Recruiting
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 0255)
Kropyvnytskyi, Kirovohrad Oblast, 25006
Study Coordinator, +380522366001
- Completed
Rivne Regional Clinical Hospital ( Site 0257)
Rivne, Rivne Oblast, 33007
- Recruiting
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0259)
Rivne, Rivne Oblast, 33010
Study Coordinator, +380503802915
- Recruiting
Uzhhorod Multispecialty City Clinical Hospital ( Site 0258)
Uzhhorod, Zakarpattia Oblast, 88017
Study Coordinator, +380312642332
Canada5 sites, 5 recruiting
- Recruiting
Cross Cancer Institute ( Site 0033)
Edmonton, Alberta, T6G 1Z2
Study Coordinator, 780-908-8213
- Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)
Hamilton, Ontario, L8V 5C2
Study Coordinator, 905-387-9495
- Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)
Kingston, Ontario, K7L 2V7
Study Coordinator, 613-549-6666x4502
- Recruiting
The Moncton Hospital ( Site 0037)
Moncton, New Brunswick, E1C 6Z8
Study Coordinator, 506-857-5104
- Recruiting
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)
Toronto, Ontario, M5G 2M9
Study Coordinator, 416-946-4501
Israel5 sites, 5 recruiting
- Recruiting
Rambam Health Care Campus-Oncology ( Site 0090)
Haifa, 3109601
Study Coordinator, +97247776234
- Recruiting
Shaare Zedek Medical Center-Oncology ( Site 0092)
Jerusalem, 9103102
Study Coordinator, +97226555768
- Recruiting
Hadassah Medical Center-Oncology ( Site 0094)
Jerusalem, 9112001
Study Coordinator, +97226776760
- Recruiting
Meir Medical Center. ( Site 0091)
Kfar Saba, 4428164
Study Coordinator, 97297472414
- Recruiting
Sheba Medical Center-ONCOLOGY ( Site 0093)
Ramat Gan, 5265601
Study Coordinator, +97235304498
Japan5 sites, 5 recruiting
- Recruiting
National Cancer Center Hospital ( Site 0403)
Chuo-ku, Tokyo, 104-0045
Study Coordinator, +81-3-3542-2511
- Recruiting
National Cancer Center Hospital East ( Site 0404)
Kashiwa, Chiba, 277-8577
Study Coordinator, +81-4-7133-1111
- Recruiting
Cancer Institute Hospital of JFCR ( Site 0400)
Koto, Tokyo, 135-8550
Study Coordinator, +81-3-3520-0111
- Recruiting
Shizuoka Cancer Center ( Site 0401)
Nakatogari, Shizuoka, 411-8777
Study Coordinator, +81-55-989-5222
- Recruiting
Kanagawa Cancer Center ( Site 0402)
Yokohama, Kanagawa, 241-8515
Study Coordinator, +81-45-520-2222
Australia4 sites, 4 recruiting
- Recruiting
Chris O'Brien Lifehouse ( Site 0002)
Camperdown, New South Wales, 2050
Study Coordinator, 61285140162
- Recruiting
Monash Health-Oncology Research ( Site 0003)
Clayton, Victoria, 3168
Study Coordinator, 6385722429
- Recruiting
Liverpool Hospital-Medical Oncology ( Site 0001)
Liverpool, New South Wales, 2170
Study Coordinator, 61287389744
- Recruiting
Westmead Hospital ( Site 0006)
Westmead, New South Wales, 2145
Study Coordinator, +61403170371
Chile4 sites, 3 recruiting
- Recruiting
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)
Santiago, Region M. de Santiago, 7500653
Study Coordinator, +56 9 9161 2199
- Recruiting
FALP-UIDO ( Site 0040)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, +56981369487
- Recruiting
Bradfordhill ( Site 0042)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, +56998744662
- Completed
James Lind Centro de Investigacion del Cancer ( Site 0043)
Temuco, Araucania, 4800827
Poland4 sites, 4 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0171)
Gdansk, Pomeranian Voivodeship, 80-952
Study Coordinator, 48585844571
- Recruiting
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0173)
Koszalin, West Pomeranian Voivodeship, 75-581
Study Coordinator, +48 94 348 84 00
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0172)
Poznan, Greater Poland Voivodeship, 60-569
Study Coordinator, 48606228277
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0170)
Warsaw, Masovian Voivodeship, 02-781
Study Coordinator, 48225463381
Turkey (Türkiye)4 sites, 2 recruiting
- Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0234)
Ankara, 06230
Study Coordinator, 905334318506
- Recruiting
Ankara Bilkent City Hospital-Medical Oncology ( Site 0233)
Ankara, 06800
Study Coordinator, +90 312 552 60 00
- Completed
Ege University Medicine of Faculty ( Site 0231)
Bornova, İzmir, 35100
- Completed
Erciyes University ( Site 0232)
Talas, Kayseri, 38039
Argentina3 sites, 3 recruiting
- Recruiting
Instituto Alexander Fleming ( Site 0434)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Study Coordinator, +541132218900
- Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)
La Rioja, F5300COE
Study Coordinator, +549380 4425438
- Recruiting
Sanatorio Parque ( Site 0456)
Rosario, Santa Fe Province, S2000DSV
Study Coordinator, 5493416955611
Italy3 sites, 3 recruiting
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)
Naples, 80131
Study Coordinator, 08117770810
- Recruiting
Humanitas ( Site 0113)
Rozzano, Lombardy, 20089
Study Coordinator, 00390282244559
- Recruiting
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111)
Siena, Tuscany, 53100
Study Coordinator, 00390577586335
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron-Oncology ( Site 0212)
Barcelona, 08035
Study Coordinator, 34 93 274 60 00x6988
- Recruiting
Clinica Universidad de Navarra ( Site 0213)
Madrid, Madrid, Comunidad de, 28027
Study Coordinator, 34913531920x7501
- Recruiting
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0211)
Madrid, Madrid, Comunidad de, 28040
Study Coordinator, 34 91 550 48 00x2689
Taiwan3 sites, 3 recruiting
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 0445)
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Study Coordinator, 886-7-7317123
- Recruiting
National Cheng Kung University Hospital ( Site 0444)
Tainan, 704
Study Coordinator, +88662353535
- Recruiting
National Taiwan University Hospital-Oncology ( Site 0443)
Taipei, 10002
Study Coordinator, +886223123456
Lithuania2 sites, 2 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 0121)
Kaunas, Kaunas County, 45433
Study Coordinator, +370 600 04799
- Recruiting
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 0120)
Vilnius, LT-08406
Study Coordinator, +37064565101
Panama2 sites, 1 recruiting
- Recruiting
Centro Oncologico de Panama ( Site 0160)
Panama City, 082410
Study Coordinator, +50764807461
- Completed
Centro Hemato Oncológico Paitilla ( Site 0163)
Panama City, 0832-00752
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital ( Site 0191)
Seoul, 03080
Study Coordinator, 82220722995
- Recruiting
Samsung Medical Center-Division of Hematology/Oncology ( Site 0193)
Seoul, 06351
Study Coordinator, +82-2-3410-3459
Switzerland2 sites, 2 recruiting
- Recruiting
Ospedale Regionale Bellinzona e Valli ( Site 0220)
Bellinzona, Canton Ticino, 6500
Study Coordinator, 41918118045
- Recruiting
Cantonal Hospital St.Gallen ( Site 0224)
Sankt Gallen, Canton of St. Gallen, 9007
Study Coordinator, 071/494 11 11
Denmark1 site, 1 recruiting
- Recruiting
Odense Universitetshospital-Department of oncology ( Site 0421)
Odense, Region Syddanmark, 5000
Study Coordinator, +45 66113333
Malaysia1 site, 1 recruiting
- Recruiting
Sarawak General Hospital ( Site 0453)
Kuching, Sarawak, 93586
Study Coordinator, 082-276666
New Zealand1 site
- Completed
New Zealand Clinical Research (Christchurch) ( Site 0004)
Christchurch, Canterbury, 8011
About this study
Official title: 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
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
- Advanced Solid Tumors
- Being tested
- Calderasib, Pembrolizumab, carboplatin, pemetrexed, cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalderasibDrug
Also called MK-1084
Oral dose
PembrolizumabBiological
Also called KEYTRUDA®, MK-3475
Intravenous infusion of 200 mg
carboplatinDrug
Per label
pemetrexedDrug
Per label
cetuximabBiological
Per label
oxaliplatinDrug
Per label
leucovorinDrug
Per label
5-fluorouracilDrug
Per label
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive daily oral escalating doses of up to 800 mg of calderasib until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety. Receives: Drug: Calderasib |
| Arm 2 | Experimental | Participants will receive calderasib 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 calderasib will continue until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety. Receives: Drug: Calderasib; Biological: Pembrolizumab |
| Arm 3 | Experimental | Participants will receive alternate formulation of calderasib until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety. Receives: Drug: Calderasib |
| Arm 4 | Experimental | Participants will receive calderasib 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. Receives: Drug: Calderasib; Biological: Pembrolizumab; Drug: carboplatin; Drug: pemetrexed |
| Arm 5 | Experimental | Participants will receive calderasib daily oral dose plus an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle. Receives: Drug: Calderasib; Biological: cetuximab |
| Arm 6 | Experimental | Participants will receive calderasib 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. Receives: Drug: Calderasib; Biological: cetuximab; Drug: oxaliplatin; Drug: leucovorin; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT will be reported.
Measured: Up to ~21 days
Number of Participants Who Experience an Adverse Event (AE)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be reported.
Measured: Up to ~56 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to ~56 months
Secondary outcomes (9)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 will be reported.
Measured: Up to ~56 months
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by the investigator will be reported.
Measured: Up to ~56 months
Mean Plasma Concentration of calderasib
Mean Plasma Concentration of calderasib determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Maximum Concentration (Cmax) of calderasib
Cmax of calderasib determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6).
Time to Maximum Concentration (Tmax) of calderasib
Tmax of calderasib determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Minimum Concentration (Cmin) of calderasib
Cmin of calderasib determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: At designated timepoints during the study in Cycles 1, 2, 3, 5, 9, 13, 17, 21, 25, and every 6 weeks thereafter up to 56 months. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Area Under the Concentration Time-Curve 0-12 Hours (AUC 0-12) of calderasib
AUC 0-12 of calderasib determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: At designated timepoint during the study in Cycle 1 Day 1: Predose and up to 12 hours postdose. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Area Under the Concentration Time-Curve 0-24 Hours (AUC 0-24) of calderasib
AUC 0-24 of calderasib determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: At designated timepoint during the study in Cycle 1 Day 1: Predose and up to 24 hours postdose. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Half-Life (t1/2) of calderasib
Half-Life (t1/2) of calderasib determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: At designated timepoint during the study in Cycle 1 Day 1: Predose and up to 24 hours postdose. Cycle=3 weeks (Arms 1-4) and 4 weeks (Arms 5-6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start17 Dec 2021
- Primary completion25 Feb 2030 (estimated)
- Study completion25 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067283
- Sponsor's protocol ID
- 1084-001
- Other IDs
- MK-1084-001, jRCT2041220034, 2022-501563-40-00, U1111-1281-2482
- Acronym
- KANDLELIT-001
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Ma X, Sloman DL, Duggal R, Anderson KD, Ballard JE, Bharathan I, Brynczka C, Gathiaka S, Henderson TJ, Lyons TW, Miller R, Munsell EV, Orth P, Otte RD, Palani A, Rankic DA, Robinson MR, Sather AC, Solban N, Song XS, Wen X, Xu Z, Yang Y, Yang R, Day PJ, Stoeck A, Bennett DJ, Han Y. Discovery of MK-1084: An Orally Bioavailable and Low-Dose KRASG12C Inhibitor. J Med Chem. 2024 Jul 11;67(13):11024-11052. doi: 10.1021/acs.jmedchem.4c00572. Epub 2024 Jun 26.
PubMed 38924388