A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC

Amgen

Status and phase: Begins enrollment in 2 months; Phase 2

Conditions: MTAP-deleted NSCLC

Treatments: Drug: AMG 193

Study type: Interventional

Funder types: Industry

Identifiers

NCT06593522

20230153

Details and patient eligibility

About

The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
• Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
• Either an archival tissue sample or an archival block must be available.
• Life expectancy of greater than 3 months, in the opinion of the investigator.
• Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
• Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.

Exclusion criteria

Disease Related

• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2), KRAS proto-oncogene (KRAS).

Other Medical Conditions

• Major surgery within 28 days of study day 1.
• Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Part 1: Dose Evaluation

Experimental group

Description:

Participants will be randomized to receive one of 2 active dose levels of AMG 193 orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D).

Treatment:

Drug: AMG 193

Part 2: Dose Expansion

Experimental group

Description:

Participants will receive AMG 193 PO QD in 28-day cycles at the RP2D.

Treatment:

Drug: AMG 193