Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jonathan Goldman, MD (ucla)
Headshot of Jonathan Goldman
Jonathan Goldman

Description

Summary

The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).

Official Title

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

Keywords

MTAP-null Non-Small-Cell Lung Cancer, MTAP-null Solid Tumors, Oncology, AMG 193, IDE397, Non-Small-Cell Lung Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
  2. Presence of advanced/metastatic solid tumor not amenable to curative treatment
    1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
    2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
  3. Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
  4. Disease measurable as defined by RECIST v1.1
  5. Adequate organ function as defined in the protocol.
  6. Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.

You CAN'T join if...

  1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
  2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
  3. Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
  4. Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)
  5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
  6. Prior irradiation to > 25% of the bone marrow
  7. Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.

Locations

  • City of Hope National Medical Center
    Duarte California 91090 United States
  • Sarah Cannon Research Institute
    Denver Colorado 80218 United States

Lead Scientist at University of California Health

  • Jonathan Goldman, MD (ucla)
    Hs Clinical Professor, Medicine. Authored (or co-authored) 111 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT05975073
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 53 people participating
Last Updated