Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1
2 other identifiers
interventional
731
2 countries
222
Brief Summary
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2019
Longer than P75 for phase_1
222 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
December 24, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 30, 2025
September 1, 2025
8 years
December 18, 2018
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
Number of participants with treatment related adverse events
20 months
Evaluate the pharmacokinetics of MRTX849
Blood plasma concentration
20 months
Evaluate clinical activity/efficacy of MRTX849
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
20 months
Secondary Outcomes (4)
Establish maximum tolerated dose
12 months
Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents
12 months
Evaluate the pharmacokinetics of new MRTX849 oral formulations
6 months
Evaluate the pharmacokinetics of MRTX849 administered with food
6 months
Study Arms (9)
Phase 1 Dose Exploration
EXPERIMENTALDose escalation of MRTX849 to determine maximum tolerated dose
Phase 1b Expansion
EXPERIMENTALExpansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
Phase 2
EXPERIMENTALSeparate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849
Pilot Phase 1b Combination with Pembrolizumab
EXPERIMENTALPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC
Pilot Phase 1b Combination with Cetuximab
EXPERIMENTALPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Pilot Phase 1b Combination with Afatinib
EXPERIMENTALPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC
Phase 2 Combination with Cetuximab
EXPERIMENTALPhase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Pilot Phase 1b Combination with Cetuximab in NSCLC
EXPERIMENTALPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC
Pilot Phase 1b Combination with Cetuximab in PDAC
EXPERIMENTALPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)
Interventions
MRTX849 will be administered orally once or twice daily in a continuous regimen
Pembrolizumab is administered as an intravenous infusion once every 3 weeks
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Afatinib will be administered orally once a day in a continuous regimen
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
- Unresectable or metastatic disease
- Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
- Adequate organ function
You may not qualify if:
- History of intestinal disease or major gastric surgery or inability to swallow oral medications
- Other active cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (222)
Local Institution - 001-826
Birmingham, Alabama, 35294, United States
Local Institution - 001-965
Anchorage, Alaska, 99508, United States
Local Institution - 001-821
Phoenix, Arizona, 85054, United States
Local Institution - 001-873-A
Tucson, Arizona, 85704, United States
Local Institution - 001-873
Tucson, Arizona, 85704, United States
Local Institution - 001-840-B
Bellflower, California, 90706, United States
Local Institution - 001-834
Beverly Hills, California, 90211, United States
Local Institution - 001-843
Duarte, California, 91010, United States
Local Institution - 001-850-K
Dublin, California, 94568, United States
Local Institution - 001-851
Fullerton, California, 92835, United States
Local Institution - 001-840-C
Harbor City, California, 90710, United States
Local Institution - 001-805
La Jolla, California, 92093, United States
Local Institution - 001-779
Los Alamitos, California, 90720, United States
Local Institution - 001-840
Los Angeles, California, 90027, United States
Local Institution - 001-578
Los Angeles, California, 90067, United States
Local Institution - 001-847
Newport Beach, California, 92663, United States
Local Institution - 001-850-B
Oakland, California, 94611, United States
Local Institution - 001-803
Orange, California, 92868, United States
Local Institution - 001-850-C
Roseville, California, 95661, United States
Local Institution - 001-850-J
Sacramento, California, 95814, United States
Local Institution - 001-850-D
Sacramento, California, 95825, United States
Local Institution - 001-845
San Diego, California, 92111, United States
Local Institution - 001-840-A
San Diego, California, 92120, United States
Local Institution - 001-850-H
San Francisco, California, 94080, United States
Local Institution - 001-850-E
San Francisco, California, 94115, United States
Local Institution - 001-850-F
San Jose, California, 95119, United States
Local Institution - 001-850-A
San Leandro, California, 94577, United States
Local Institution - 001-884
Santa Barbara, California, 93105, United States
Local Institution - 001-850-I
Santa Clara, California, 95051, United States
Local Institution - 001-884-A
Solvang, California, 93463, United States
Local Institution - 001-850
Vallejo, California, 94589, United States
Local Institution - 001-850-G
Walnut Creek, California, 94596, United States
Local Institution - 001-872
Aurora, Colorado, 80012, United States
Local Institution - 001-810
Aurora, Colorado, 80045, United States
Local Institution - 001-872-H
Boulder, Colorado, 80303, United States
Local Institution - 001-872-E
Colorado Springs, Colorado, 80907, United States
Local Institution - 001-872-L
Colorado Springs, Colorado, 80920, United States
Local Institution - 001-872-B
Denver, Colorado, 80218, United States
Local Institution - 001-951 - A
Denver, Colorado, 80218, United States
Local Institution - 001-951 - B
Denver, Colorado, 80218, United States
Local Institution - 001-846
Grand Junction, Colorado, 81501, United States
Local Institution - 001-951
Lafayette, Colorado, 80026, United States
Local Institution - 001-872-A
Lakewood, Colorado, 80228, United States
Local Institution - 001-872-D
Littleton, Colorado, 80218, United States
Local Institution - 001-872-K
Lone Tree, Colorado, 80124, United States
Local Institution - 001-872-C
Longmont, Colorado, 80501, United States
Local Institution - 001-872-J
Parker, Colorado, 80138, United States
Local Institution - 001-872-F
Pueblo, Colorado, 81008, United States
Local Institution - 001-872-G
Pueblo, Colorado, 81008, United States
Local Institution - 001-872-I
Thornton, Colorado, 80260, United States
Local Institution - 001-816
New Haven, Connecticut, 06510, United States
Local Institution - 001-871
Newark, Delaware, 19713-2055, United States
Local Institution - 001-929i
Altamonte Springs, Florida, 32701, United States
Local Institution - 001-839
Boca Raton, Florida, 33432, United States
Local Institution - 001-922A
Bonita Springs, Florida, 34135, United States
Local Institution - 001-922D
Bradenton, Florida, 34211, United States
Local Institution - 001-929c
Brandon, Florida, 33511, United States
Local Institution - 001-922E
Cape Coral, Florida, 33909, United States
Local Institution - 001-929g
Clearwater, Florida, 33761, United States
Local Institution - 001-926b
Daytona Beach, Florida, 32117, United States
Local Institution - 001-922
Fort Myers, Florida, 33901, United States
Local Institution - 001-922B
Fort Myers, Florida, 33905, United States
Local Institution - 001-922C
Fort Myers, Florida, 33908, United States
Local Institution - 001-929b
Gainesville, Florida, 32605, United States
Local Institution - 001-829
Jacksonville, Florida, 32224, United States
Local Institution - 001-929m
Lady Lake, Florida, 32159, United States
Local Institution - 001-929e
Largo, Florida, 33770, United States
Local Institution - 001-929n
Lecanto, Florida, 34461, United States
Local Institution - 001-870
Miami, Florida, 33176, United States
Local Institution - 001-825
Miami Beach, Florida, 33140, United States
Local Institution - 001-922F
Naples, Florida, 34102, United States
Local Institution - 001-922G
Naples, Florida, 34102, United States
Local Institution - 001-538
Ocala, Florida, 34474, United States
Local Institution - 001-929p
Ocala, Florida, 34474, United States
Local Institution - 001-914
Orange City, Florida, 32763, United States
Local Institution - 001-929j
Orange City, Florida, 32763, United States
Local Institution - 001-929l
Orlando, Florida, 32806, United States
Local Institution - 001-877
Pensacola, Florida, 32503, United States
Local Institution - 001-922H
Port Charlotte, Florida, 33980, United States
Local Institution - 001-922I
Sarasota, Florida, 34232, United States
Local Institution - 001-922J
Sarasota, Florida, 34236, United States
Local Institution - 001-929h
Spring Hill, Florida, 34608, United States
Local Institution - 001-929a
St. Petersburg, Florida, 33705, United States
Local Institution - 001-929
St. Petersburg, Florida, 33705, United States
Local Institution - 001-926d
Stuart, Florida, 34994, United States
Local Institution - 001-929d
Tampa, Florida, 33607, United States
Local Institution - 001-929k
Tavares, Florida, 32778, United States
Local Institution - 001-929f
Trinity, Florida, 34655, United States
Local Institution - 001-922K
Venice, Florida, 34285, United States
Local Institution - 001-922L
Venice, Florida, 34292, United States
Local Institution - 001-926c
Vero Beach, Florida, 32960, United States
Local Institution - 001-926a
Wellington, Florida, 33414, United States
Local Institution - 001-926
West Palm Beach, Florida, 33401, United States
Local Institution - 001-929o
Winter Park, Florida, 32789, United States
Local Institution - 001-967
Athens, Georgia, 30607, United States
Local Institution - 001-835-C
Austell, Georgia, 30106, United States
Local Institution - 001-835-E
Austell, Georgia, 30106, United States
Local Institution - 001-835-D
Carrollton, Georgia, 30117, United States
Local Institution - 001-835-F
Carrollton, Georgia, 30117, United States
Local Institution - 001-835-A
Cartersville, Georgia, 30121, United States
Local Institution - 001-835-B
Douglasville, Georgia, 30134, United States
Local Institution - 001-835
Marietta, Georgia, 30060, United States
Local Institution - 001-862
Chicago Ridge, Illinois, 60415, United States
Local Institution - 001-883
Niles, Illinois, 60714, United States
Local Institution - 001-781
South Bend, Indiana, 46601, United States
Local Institution - 001-831
Iowa City, Iowa, 52242, United States
Local Institution - 001-820
Westwood, Kansas, 66205, United States
Local Institution - 001-844
Lexington, Kentucky, 40536, United States
Local Institution - 001-920
Baton Rouge, Louisiana, 70809, United States
Local Institution - 001-827
Biddeford, Maine, 04005, United States
Local Institution - 001-881-B
Brandywine, Maryland, 20613, United States
Local Institution - 001-881
Columbia, Maryland, 21044, United States
Local Institution - 001-881-A
Silver Spring, Maryland, 20904, United States
Local Institution - 001-808
Boston, Massachusetts, 02215, United States
Local Institution - 001-842
Detroit, Michigan, 48201, United States
Local Institution - 001-811
Detroit, Michigan, 48202, United States
Local Institution - 001-842-A
Farmington Hills, Michigan, 48334, United States
Local Institution - 001-838-F
Coon Rapids, Minnesota, 55433, United States
Local Institution - 001-838-E
Edina, Minnesota, 55435, United States
Local Institution - 001-875 - D
Edina, Minnesota, 55435, United States
Local Institution - 001-838-D
Maplewood, Minnesota, 55109, United States
Local Institution - 001-875 - A
Maplewood, Minnesota, 55109, United States
Local Institution - 001-838-C
Minneapolis, Minnesota, 55404, United States
Local Institution - 001-875
Minneapolis, Minnesota, 55404, United States
Local Institution - 001-838-G
Minneapolis, Minnesota, 55415, United States
Local Institution - 001-822-A
Minneapolis, Minnesota, 55455, United States
Local Institution - 001-822
Minneapolis, Minnesota, 55455, United States
Local Institution - 001-830
Rochester, Minnesota, 55905, United States
Local Institution - 001-838
Saint Louis Park, Minnesota, 55416, United States
Local Institution - 001-838-B
Saint Louis Park, Minnesota, 55426-5000, United States
Local Institution - 001-838-A
Saint Paul, Minnesota, 55101, United States
Local Institution - 001-875 - B
Saint Paul, Minnesota, 55102, United States
Local Institution - 001-875 - C
Woodbury, Minnesota, 55125, United States
Local Institution - 001-952
Bolivar, Missouri, 65613, United States
Local Institution - 001-950
Jefferson City, Missouri, 65109, United States
Local Institution - 001-841
Billings, Montana, 59102, United States
Local Institution - 001-544B
Omaha, Nebraska, 68105-1850, United States
Local Institution - 001-959
Omaha, Nebraska, 68114, United States
Local Institution - 001-544A
Omaha, Nebraska, 68118, United States
Local Institution - 001-544
Omaha, Nebraska, 68198, United States
Local Institution - 001-860A
Henderson, Nevada, 89052, United States
Local Institution - 001-860C
Henderson, Nevada, 89052, United States
Local Institution - 001-860B
Henderson, Nevada, 89074, United States
Local Institution - 001-860
Henderson, Nevada, 89074, United States
Local Institution - 001-860E
Las Vegas, Nevada, 89128, United States
Local Institution - 001-860D
Las Vegas, Nevada, 89144, United States
Local Institution - 001-860F
Las Vegas, Nevada, 89148, United States
Local Institution - 001-861
Albany, New York, 12206, United States
Local Institution - 001-815
Buffalo, New York, 14203, United States
Local Institution - 001-813
New York, New York, 10016, United States
Local Institution - 001-806
New York, New York, 10065, United States
Local Institution - 001-812
Chapel Hill, North Carolina, 27514, United States
Local Institution - 001-971
Pinehurst, North Carolina, 28374, United States
Local Institution - 001-966
Cincinnati, Ohio, 45219, United States
Local Institution - 001-823
Cincinnati, Ohio, 45267, United States
Local Institution - 001-818
Cleveland, Ohio, 44195, United States
Local Institution - 001-833 - H
Columbus, Ohio, 43201, United States
Local Institution - 001-833 - C
Columbus, Ohio, 43203, United States
Local Institution - 001-833 - J
Columbus, Ohio, 43203, United States
Local Institution - 001-833 - A
Columbus, Ohio, 43210, United States
Local Institution - 001-833 - F
Columbus, Ohio, 43210, United States
Local Institution - 001-833
Columbus, Ohio, 43210, United States
Local Institution - 001-833 - D
Columbus, Ohio, 43212, United States
Local Institution - 001-833 - I
Columbus, Ohio, 43212, United States
Local Institution - 001-930
Columbus, Ohio, 43219, United States
Local Institution - 001-833 - B
Columbus, Ohio, 43221, United States
Local Institution - 001-833 - G
Columbus, Ohio, 43221, United States
Local Institution - 001-833 - E
Gahanna, Ohio, 43230, United States
Local Institution - 001-836-A
Kettering, Ohio, 45429, United States
Local Institution - 001-836
Kettering, Ohio, 45429, United States
Local Institution - 001-600
Lawton, Oklahoma, 73505, United States
Local Institution - 001-584
Tulsa, Oklahoma, 74146, United States
Local Institution - 001-586-A
Bend, Oregon, 97701, United States
Local Institution - 001-586
Bend, Oregon, 97701, United States
Local Institution - 001-889
Eugene, Oregon, 97401, United States
Local Institution - 001-837
Allentown, Pennsylvania, 18103, United States
Local Institution - 001-837-A
Bethlehem, Pennsylvania, 18017, United States
Local Institution - 001-817
Hershey, Pennsylvania, 17033-0850, United States
Local Institution - 001-783
Media, Pennsylvania, 19063, United States
Local Institution - 001-887
Charleston, South Carolina, 29414, United States
Local Institution - 001-819
Charleston, South Carolina, 29425, United States
Local Institution - 001-801-G
Gallatin, Tennessee, 37066, United States
Local Institution - 001-801-A
Hendersonville, Tennessee, 37075, United States
Local Institution - 001-801-D
Hermitage, Tennessee, 37076, United States
Local Institution - 001-801-F
Murfreesboro, Tennessee, 37129, United States
Local Institution - 001-801-B
Nashville, Tennessee, 37203, United States
Local Institution - 001-801
Nashville, Tennessee, 37203, United States
Local Institution - 001-801-E
Nashville, Tennessee, 37207, United States
Local Institution - 001-801-C
Nashville, Tennessee, 37211, United States
Local Institution - 001-888-B
Arlington, Texas, 76012, United States
Local Institution - 001-888
Arlington, Texas, 76012, United States
Local Institution - 001-880
Austin, Texas, 78731, United States
Local Institution - 001-848a
Conroe, Texas, 77384, United States
Local Institution - 001-809
Dallas, Texas, 75230, United States
Local Institution - 001-886
Dallas, Texas, 75231, United States
Local Institution - 001-879
Dallas, Texas, 75246, United States
Local Institution - 001-785
Denison, Texas, 75020, United States
Local Institution - 001-876
Fort Worth, Texas, 76104, United States
Local Institution - 001-848
Houston, Texas, 77030, United States
Local Institution - 001-969
Houston, Texas, 77030, United States
Local Institution - 001-935A
Houston, Texas, 77090, United States
Local Institution - 001-999
Irving, Texas, 75063, United States
Local Institution - 001-935D
Kingwood, Texas, 77339, United States
Local Institution - 001-935
Kingwood, Texas, 77339, United States
Local Institution - 001-554
Midland, Texas, 79701, United States
Local Institution - 001-802
San Antonio, Texas, 78229, United States
Local Institution - 001-935B
Shenandoah, Texas, 77380, United States
Local Institution - 001-935C
Spring, Texas, 77389, United States
Local Institution - 001-874
Sugar Land, Texas, 77479, United States
Local Institution - 001-935E
Tomball, Texas, 77375, United States
Local Institution - 001-878
Tyler, Texas, 75702, United States
Local Institution - 001-890
Waco, Texas, 76712, United States
Local Institution - 001-814
Fairfax, Virginia, 22031, United States
Local Institution - 001-597
Fredericksburg, Virginia, 24408, United States
Local Institution - 001-882
Newport News, Virginia, 23606, United States
Local Institution - 001-882-A
Norfolk, Virginia, 23502, United States
Local Institution - 001-890-A
Norfolk, Virginia, 23502, United States
Local Institution - 001-968
Richmond, Virginia, 23229, United States
Local Institution - 001-824
Seattle, Washington, 98109, United States
Local Institution - 001-885
Vancouver, Washington, 98684, United States
Local Institution - 001-804
Madison, Wisconsin, 53792, United States
Local Institution - 001-900
San Juan, PR, 00935, Puerto Rico
Related Publications (7)
Negrao MV, Spira AI, Heist RS, Janne PA, Pacheco JM, Weiss J, Gadgeel SM, Velastegui K, Yang W, Der-Torossian H, Christensen JG, Sabari JK. Intracranial Efficacy of Adagrasib in Patients From the KRYSTAL-1 Trial With KRASG12C-Mutated Non-Small-Cell Lung Cancer Who Have Untreated CNS Metastases. J Clin Oncol. 2023 Oct 1;41(28):4472-4477. doi: 10.1200/JCO.23.00046. Epub 2023 Jun 16.
PMID: 37327468DERIVEDBekaii-Saab TS, Yaeger R, Spira AI, Pelster MS, Sabari JK, Hafez N, Barve M, Velastegui K, Yan X, Shetty A, Der-Torossian H, Pant S. Adagrasib in Advanced Solid Tumors Harboring a KRASG12C Mutation. J Clin Oncol. 2023 Sep 1;41(25):4097-4106. doi: 10.1200/JCO.23.00434. Epub 2023 Apr 26.
PMID: 37099736DERIVEDYaeger R, Weiss J, Pelster MS, Spira AI, Barve M, Ou SI, Leal TA, Bekaii-Saab TS, Paweletz CP, Heavey GA, Christensen JG, Velastegui K, Kheoh T, Der-Torossian H, Klempner SJ. Adagrasib with or without Cetuximab in Colorectal Cancer with Mutated KRAS G12C. N Engl J Med. 2023 Jan 5;388(1):44-54. doi: 10.1056/NEJMoa2212419. Epub 2022 Dec 21.
PMID: 36546659DERIVEDJanne PA, Riely GJ, Gadgeel SM, Heist RS, Ou SI, Pacheco JM, Johnson ML, Sabari JK, Leventakos K, Yau E, Bazhenova L, Negrao MV, Pennell NA, Zhang J, Anderes K, Der-Torossian H, Kheoh T, Velastegui K, Yan X, Christensen JG, Chao RC, Spira AI. Adagrasib in Non-Small-Cell Lung Cancer Harboring a KRASG12C Mutation. N Engl J Med. 2022 Jul 14;387(2):120-131. doi: 10.1056/NEJMoa2204619. Epub 2022 Jun 3.
PMID: 35658005DERIVEDSabari JK, Velcheti V, Shimizu K, Strickland MR, Heist RS, Singh M, Nayyar N, Giobbie-Hurder A, Digumarthy SR, Gainor JF, Rajan AP, Nieblas-Bedolla E, Burns AC, Hallin J, Olson P, Christensen JG, Kurz SC, Brastianos PK, Wakimoto H. Activity of Adagrasib (MRTX849) in Brain Metastases: Preclinical Models and Clinical Data from Patients with KRASG12C-Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2022 Aug 2;28(15):3318-3328. doi: 10.1158/1078-0432.CCR-22-0383.
PMID: 35404402DERIVEDOu SI, Janne PA, Leal TA, Rybkin II, Sabari JK, Barve MA, Bazhenova L, Johnson ML, Velastegui KL, Cilliers C, Christensen JG, Yan X, Chao RC, Papadopoulos KP. First-in-Human Phase I/IB Dose-Finding Study of Adagrasib (MRTX849) in Patients With Advanced KRASG12C Solid Tumors (KRYSTAL-1). J Clin Oncol. 2022 Aug 10;40(23):2530-2538. doi: 10.1200/JCO.21.02752. Epub 2022 Feb 15.
PMID: 35167329DERIVEDAwad MM, Liu S, Rybkin II, Arbour KC, Dilly J, Zhu VW, Johnson ML, Heist RS, Patil T, Riely GJ, Jacobson JO, Yang X, Persky NS, Root DE, Lowder KE, Feng H, Zhang SS, Haigis KM, Hung YP, Sholl LM, Wolpin BM, Wiese J, Christiansen J, Lee J, Schrock AB, Lim LP, Garg K, Li M, Engstrom LD, Waters L, Lawson JD, Olson P, Lito P, Ou SI, Christensen JG, Janne PA, Aguirre AJ. Acquired Resistance to KRASG12C Inhibition in Cancer. N Engl J Med. 2021 Jun 24;384(25):2382-2393. doi: 10.1056/NEJMoa2105281.
PMID: 34161704DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 18, 2018
First Posted
December 24, 2018
Study Start
January 15, 2019
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share