Home › Trials › NCT06333951

AMG 193 treatment for advanced thoracic tumors with MTAP deletion

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

Phase 1 Interventional Amgen · NCT06333951

This study is testing a new treatment called AMG 193, alone or with other drugs, to see if it helps adults with advanced lung cancer and other tumors that have a specific genetic change.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionspembrolizumab, Radiation
Locations83 sites (Bakersfield, California and 82 other locations)
Trial IDNCT06333951 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and maximum tolerated dose of AMG 193, a PRMT5 inhibitor, either alone or in combination with other therapies such as carboplatin, paclitaxel, and pembrolizumab in adults with advanced thoracic tumors that have a homozygous MTAP deletion. The study aims to determine the effectiveness of these combinations in treating non-small cell lung cancer (NSCLC) and other thoracic tumors. Participants will be monitored for safety and response to treatment based on established criteria.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced thoracic tumors exhibiting homozygous MTAP deletion and measurable disease.

Not a fit: Patients without homozygous MTAP deletion or those with other types of thoracic tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced thoracic tumors that have limited treatment alternatives.

How similar studies have performed: While this approach is novel, similar studies targeting specific genetic mutations in cancer have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

Subprotocol A, B, and C

* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
* Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing.
* Homozygous MTAP-deletion
* Able to swallow and retain PO administered study treatment.
* Disease measurable as defined by RECIST v1.1.

Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.

Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab):

\- Predominantly squamous histology.

Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab):

\- Predominantly non-squamous histology.

Arm C (Anvumetostat + pembrolizumab):

\- PD-L1 positive.

Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.

Subprotocol C

* Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
* Brain lesion meeting RANO-BM criteria for measurable disease.

Exclusion Criteria

Subprotocol A, B, and C

* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
* 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).
* History of solid organ transplant.
* Major surgery within 28 days of first dose of Anvumetostat.
* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
* Radiation therapy within 28 days of first dose.

Subprotocol A

\- Autoimmune disease or immunodeficiency disease as defined in the protocol'

Where this trial is running

Bakersfield, California and 82 other locations

+33 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thoracic TumorsNon-small Cell Lung CancerOncologyMethylthioadenosine phosphorylaseAMG 193PRMT5 inhibitorMTAPNSCLC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.