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 (MTAP)

  • STATUS
    Recruiting
  • End date
    Nov 14, 2026
  • participants needed
    340
  • sponsor
    Amgen
Updated on 15 October 2022

Summary

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 objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null non-small cell lung cancer (NSCLC), after prior treatment with chemotherapy and/or a programmed death-1/ligand 1 (PD-1/L1) inhibitor.

Details
Condition Advanced MTAP-null Solid Tumors
Treatment docetaxel, AMG 193
Clinical Study IdentifierNCT05094336
SponsorAmgen
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has provided informed consent/assent before initiation of any study specific activities/procedures
Age ≥ 18 years
Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) and/or methylthioadenosine phosphorylase (MTAP) (null) or lost MTAP expression in the tumor tissue
Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation
Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product
Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Adequate hematopoietic function per local laboratory
Adequate renal function per local laboratory
Adequate glucose control per local laboratory (Part 1 only)
Adequate liver function per local laboratory
Adequate coagulation parameters
Adequate pulmonary function
Adequate cardiac function
Minimum life expectancy of 12 weeks as per investigator judgement
Tumor tissue must be available

Exclusion Criteria

Spinal cord compression or active brain metastases or leptomeningeal disease from non-brain tumors
Presence of primary brain cancer
Presence of hematological malignancy or lymphoma
History of other malignancy within the past 2 years
Evidence of lung disease
Active infection
History of arterial thrombosis
Myocardial infarction and/or symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
Gastrointestinal tract disease
History of solid organ transplant
Diagnosis of Congenital Short QT Syndrome
Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor
Prior irradiation to greater than 25% of the bone marrow
Unresolved toxicity from prior anti-cancer therapy
Currently receiving treatment in another investigational device or drug study
Known positive test for Human Immunodeficiency Virus
Evidence of hepatitis B or C infection
Female participants of childbearing potential with a positive pregnancy test
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