Clinical Trial - NCT03600883

       

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreak 100)

Recruiting

Sponsor: Amgen

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03600883

Protocol Info

Short Description: Phase 1 AMG 510 in Solid tumors with Specific KRAS Mutation
Long Description: A Phase I, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects with Advanced Solid Tumors with a Specific KRAS Mutation
MGH Status: Open
Sponsor: Amgen
Disease Program: Phase I

Next Steps


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Purpose

Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Condition Title Intervention Phase
KRAS p.G12C Mutant Advanced Solid Tumors AMG 510 Phase 1/Phase 2
Study Type Interventional
Official Title A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreak 100)

Primary Outcome Measures

Number of Participants With Abnormal Laboratory Values [Time Frame: 24 Months] [Designated as safety issue: ]

Number of subjects with clinically significant changes in vital signs. [Time Frame: 24 Months] [Designated as safety issue: ]

Number of subjects with changes on ECG. [Time Frame: 24 Months] [Designated as safety issue: ]

Objective response rate (ORR) assessed by RECIST 1.1 criteria of AMG 510 as monotherapy in subjects with KRAS p.G12C mutated advanced tumors [Time Frame: 24 Months] [Designated as safety issue: ]


Secondary Outcome Measures

Plasma concentration (Cmax) [Time Frame: 24 Months] [Designated as safety issue: ]

Time to achieve Cmax (tmax) [Time Frame: 24 Months] [Designated as safety issue: ]

Area under the plasma concentration-time curve (AUC) [Time Frame: 24 Months] [Designated as safety issue: ]

Duration of overall response [Time Frame: 24 Months] [Designated as safety issue: ]

Progression-free survival [Time Frame: 24 Months] [Designated as safety issue: ]

Duration of stable disease [Time Frame: 24 Months] [Designated as safety issue: ]

Estimated Enrollment: 533
Study Start Date: August 2018
Estimated Study Completion Date: March 2024
Estimated Primary Completion Date: January 2022
Arms Assigned Interventions

Experimental:Dose Exploration Part 1 monotherapy

Cohorts with food effect and alternative dosing regimens Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort

Experimental:Dose Expansion Part 2 monotherapy

Upon completing the dose exploration part of the study, dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors Dose expansion in these 2 groups may be done concurrently

Experimental:Phase 2 monotherapy

Additional subjects will be enrolled in the dose expansion to confirm the recommended phase 2 dose. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose

Experimental:Combination arm with AMG 510 and anti PD-1/L1

Additional subjects will be enrolled into the combination arm with AMG 510 in combination with an anti (PD-1/L1)
Drug:AMG 510
Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation

Experimental:Monotherapy treatment naive advanced NSCLC

Separate cohort of part 1 dose expansion patients to evaluate the safety and clinical activity of AMG 510 administered orally once daily in patients with previously untreated advanced NSCLC

Eligibility

Ages Eligible for Study: 100 Years-100 Years

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • • Men or women greater than or equal to 18 years old.
  • • Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12Cmutation identified through DNA sequencing.

Exclusion Criteria

  • • Active brain metastases from non-brain tumors.
  • • Myocardial infarction within 6 months of study day 1.
  • • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03600883

Locations

  • United States, California
    • Research Site Duarte, California, United States, 91010
    • Research site San Francisco, California, United States, 94158
    • Research Site Santa Monica, California, United States, 90403
    • Research site Santa Monica, California, United States, 90404
  • United States, Colorado
    • Research Site Denver, Colorado, United States, 80218
    • Research site Lone Tree, Colorado, United States, 80124
  • United States, Connecticut
    • Research Site New Haven, Connecticut, United States, 06510
  • United States, Delaware
    • Research site Newark, Delaware, United States, 19713
  • United States, Florida
    • Research site Gainesville, Florida, United States, 32608
    • Research Site Orlando, Florida, United States, 32804
    • Research Site Tampa, Florida, United States, 33612
  • United States, Georgia
    • Research Site Atlanta, Georgia, United States, 30322
  • United States, Indiana
    • Research Site Indianapolis, Indiana, United States, 46202
  • United States, Maryland
    • Research site Bethesda, Maryland, United States, 20817
  • United States, Massachusetts
    • Research Site Boston, Massachusetts, United States, 02114
    • Research site Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • Research Site Ann Arbor, Michigan, United States, 48109
    • Research site Detroit, Michigan, United States, 48202
  • United States, Missouri
    • Research site Saint Louis, Missouri, United States, 63110
  • United States, New York
    • Research Site Buffalo, New York, United States, 14263
    • Research Site New York, New York, United States, 10016
    • Research Site New York, New York, United States, 10065
  • United States, North Carolina
    • Research Site Durham, North Carolina, United States, 27710
  • United States, Ohio
    • Research Site Cleveland, Ohio, United States, 44106
    • Research site Cleveland, Ohio, United States, 44195
  • United States, Pennsylvania
    • Research Site Philadelphia, Pennsylvania, United States, 19104
    • Research Site Philadelphia, Pennsylvania, United States, 19111
    • Research site Pittsburgh, Pennsylvania, United States, 15213
  • United States, South Carolina
    • Research Site Spartanburg, South Carolina, United States, 29303
  • United States, Tennessee
    • Research site Nashville, Tennessee, United States, 37203
    • Research Site Nashville, Tennessee, United States, 37232
  • United States, Texas
    • Research site Austin, Texas, United States, 78731
    • Research site Dallas, Texas, United States, 75246
    • Research Site Dallas, Texas, United States, 75390
    • Research Site Houston, Texas, United States, 77030
    • Research site Irving, Texas, United States, 75063
  • United States, Utah
    • Research Site Salt Lake City, Utah, United States, 84112
  • United States, Virginia
    • Research site Blacksburg, Virginia, United States, 20817
    • Research Site Fairfax, Virginia, United States, 22031
  • United States, Washington
    • Research Site Seattle, Washington, United States, 98109
  • Australia, New South Wales
    • Research Site Randwick, New South Wales, Australia, 2031
  • Australia, Queensland
    • Research site Woolloongabba, Queensland, Australia, 4102
  • Australia, South Australia
    • Research Site Woodville South, South Australia, Australia, 5011
  • Australia, Victoria
    • Research Site Melbourne, Victoria, Australia, 3000
  • Austria,
    • Research site Graz, , Austria, 8036
    • Research site Innsbruck, , Austria, 6020
    • Research Site Krems, , Austria, 3500
    • Research Site Wien, , Austria, 1090
  • Belgium,
    • Research Site Bruxelles, , Belgium, 1000
    • Research Site Edegem, , Belgium, 2650
    • Research Site Gent, , Belgium, 9000
    • Research Site Leuven, , Belgium, 3000
  • Brazil, Rio Grande Do Sul
    • Research site Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
    • Research site Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
  • Brazil, São Paulo
    • Research Site São José do Rio Preto, São Paulo, Brazil, 15090-000
  • Brazil,
    • Research site Rio De Janeiro, , Brazil, 22793-080
    • Research site São Paulo, , Brazil, 01308-050
    • Research site São Paulo, , Brazil, 04501-000
  • Canada, Alberta
    • Research site Calgary, Alberta, Canada, T2N 4N2
    • Research site Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, Ontario
    • Research Site London, Ontario, Canada, N6A 5W9
    • Research site Ottawa, Ontario, Canada, K1H 8L6
    • Research Site Toronto, Ontario, Canada, M5G 2M9
  • France,
    • Research Site Bordeaux, , France, 33076
    • Research site Créteil, , France, 94010
    • Research site Marseille, , France, 13005
    • Research site Paris Cedex 5, , France, 75248
    • Research Site Toulouse cedex 9, , France, 31059
    • Research Site Villejuif, , France, 94805
  • Germany,
    • Research Site Essen, , Germany, 45147
    • Research site Köln, , Germany, 50924
    • Research Site München, , Germany, 81377
  • Japan, Aichi
    • Research Site Nagoya-shi, Aichi, Japan, 464-8681
  • Japan, Chiba
    • Research Site Kashiwa-shi, Chiba, Japan, 277-8577
  • Japan, Ehime
    • Research Site Matsuyama-shi, Ehime, Japan, 791-0280
  • Japan, Fukuoka
    • Research Site Fukuoka-shi, Fukuoka, Japan, 811-1395
  • Japan, Kanagawa
    • Research Site Kawasaki-shi, Kanagawa, Japan, 216-8511
    • Research Site Yokohama-shi, Kanagawa, Japan, 241-8515
  • Japan, Miyagi
    • Research site Sendai-shi, Miyagi, Japan, 980-0873
  • Japan, Osaka
    • Research Site Hirakata-shi, Osaka, Japan, 573-1191
    • Research site Osaka-shi, Osaka, Japan, 541-8567
  • Japan, Shizuoka
    • Research Site Sunto-gun, Shizuoka, Japan, 411-8777
  • Japan, Tokyo
    • Research site Koto-Ku, Tokyo, Japan, 135-8550
  • Japan, Wakayama
    • Research site Wakayama-shi, Wakayama, Japan, 641-8510
  • Korea, Republic of,
    • Research Site Seoul, , Korea, Republic of, 03080
    • Research Site Seoul, , Korea, Republic of, 03722
    • Research Site Seoul, , Korea, Republic of, 05505
    • Research Site Seoul, , Korea, Republic of, 06591
    • Research site Seoul, , Korea, Republic of, 135-710
  • Switzerland,
    • Research site Basel, , Switzerland, 4031
    • Research Site Geneve, , Switzerland, 1211
    • Research Site Zurich, , Switzerland, 8091

Sponsors and Collaborators

Amgen

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03600883
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on November 12, 2020