ACTIVE_NOT_RECRUITING

A Study of AMG 193 in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the efficacy of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.

Official Title

A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

Quick Facts

Study Start:2022-02-01
Study Completion:2028-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05094336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has provided informed consent/assent before initiation of any study specific activities/procedures.
  2. * Age ≥ 18 years.
  3. * Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b).
  4. * Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
  5. * Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product.
  6. * Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Note: except participants enrolling to Part 1m.
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  8. * Adequate hematopoietic function per local laboratory
  9. * Adequate renal function per local laboratory
  10. * Adequate glucose control per local laboratory (Part 1 only)
  11. * Adequate liver function per local laboratory
  12. * Adequate coagulation parameters
  13. * Adequate pulmonary function
  14. * Adequate cardiac function
  15. * Minimum life expectancy of 12 weeks as per investigator judgement.
  16. * Archived tumor tissue (formalin-fixed, paraffin-embedded \[FFPE\] sample collected within 5 years) or an archival block must be available.
  17. * For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy.
  18. * For Part 1a: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment.
  19. * For DSPS study (Part 1j): Must be willing to participate in DSPS substudy (US sites only).
  20. * Subject able and willing to eat a standardized high-fat, high-caloric meal
  21. * Subject able and willing to fast for ≥ 6 hours
  1. * Spinal cord compression or untreated brain metastases or leptomeningeal disease.
  2. * History of other malignancy within the past 2 years
  3. * Any evidence of current interstitial lung disease
  4. * Active infection
  5. * Evidence of active severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection.
  6. * History of arterial thrombosis
  7. * Myocardial infarction and/or symptomatic congestive heart failure.
  8. * Gastrointestinal tract disease
  9. * History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  10. * History of solid organ transplant.
  11. * Diagnosis of Congenital Short QT Syndrome.
  12. * Major surgery
  13. * Anti-tumor therapy within 28 days of study day 1.
  14. * Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
  15. * Prior treatment with docetaxel (Part 2 only)
  16. * Prior irradiation to 25% of the bone marrow.
  17. * Therapeutic or palliative radiation therapy within 2 weeks of study day 1.
  18. * Live vaccine therapy within 4 weeks before study drug administration.
  19. * Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
  20. * Use of prescription medications that are known strong inducers of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1
  21. * Unresolved toxicity from prior anti-cancer therapy
  22. * Currently receiving treatment in another investigational device or drug study.
  23. * Known positive test for Human Immunodeficiency Virus (HIV).
  24. * Positive hepatitis B surface antigen
  25. * positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
  26. * Female participants of childbearing potential unwilling to use protocol specified method of contraception

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

City of Hope National Medical Center
Duarte, California, 91010
United States
California Research Institute
Glendale, California, 91204
United States
Fomat Medical Research
Oxnard, California, 93030
United States
University of California at SF
San Francisco, California, 94158
United States
D and H Cancer Research Center
Margate, Florida, 33063
United States
Boca Raton Clinical Research Medical Center Inc
Tamarac, Florida, 33321
United States
Goshen Health Systems
Goshen, Indiana, 46526
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Community Health Network MD Anderson Cancer Center - North
Indianapolis, Indiana, 46250
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
American Oncology Partners, PA
Bethesda, Maryland, 20817
United States
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
United States
Washington University
St Louis, Missouri, 63110
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Roswell Park Cancer Institute
Buffalo, New York, 32224
United States
Northwell Health Monter Cancer Center
Lake Success, New York, 11042
United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, 10016
United States
Duke University
Durham, North Carolina, 27710
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, 54104
United States
Sarah Cannon Research Institute
Dallas, Texas, 75230
United States
Center for Oncology and Blood Disorders
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Lumi Research
Kingwood, Texas, 77339
United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Virginia Cancer Specialists PC
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2028-05-30

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2028-05-30

Terms related to this study

Keywords Provided by Researchers

  • Metastatic MTAP-null solid tumors
  • Advanced MTAP-null solid tumors
  • Non-small cell lung cancer
  • Biliary Tract Cancer (BTC)
  • Head and neck squamous cell carcinoma
  • Pancreatic adenocarcinoma
  • Esophageal cancer
  • Gastric cancer
  • Glioma

Additional Relevant MeSH Terms

  • Advanced MTAP-null Solid Tumors