A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
Iizumi Sakura
Amgen K.K.
Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo
+81-80-7217-8592
clinicaltrials_japan@amgen.com
Local Contact
Amgen K.K.
Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo
+81-80-7217-8592
clinicaltrials_japan@amgen.com
Recruiting
Dec. 26, 2024
Dec. 26, 2024
200
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
1. Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC
2. 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.
3. Either an archival tissue sample or an archival block must be available.
4. Life expectancy of greater than 3 months, in the opinion of the investigator.
5. 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.
6. 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.
Disease Related
1. 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/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).
Other Medical Conditions
2. Major surgery within 28 days of study day 1.
3. Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2cm per lesion.
18age old over
No limit
Both
MTAP-deleted NSCLC
Experimental: Part 1: Dose Evaluation
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).
Interventions: Drug: AMG 193
Experimental: Part 2: Dose Expansion
Participants will receive AMG 193 PO QD in 28-day cycles at the RP2D.
Interventions: Drug: AMG 193
1. Objective Response (OR) per RECIST 1.1 [Time Frame: Up to 35 months]
2. Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1) [Time Frame: Up to 35 months]
3. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to 35 months]
4. Number of Participants Experiencing Events of Interest (EOIs) [Time Frame: Up to 35 months]
5. Maximum Concentration (Cmax) of AMG 193 [Time Frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose]
6. Time to Cmax (Tmax) of AMG 193 [Time Frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose]
7. Area Under The Concentration-time Curve (AUC) of AMG 193 [Time Frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose]
1. Disease Control (DC) by BICR [Time Frame: Up to 35 months]
2. Duration of Response (DOR) by BICR [Time Frame: Up to 35 months]
3. Time to Response (TTR) by BICR [Time Frame: Up to 35 months]
4. Progression-free Survival (PFS) by BICR [Time Frame: Up to 35 months]
5. OR by Investigator's Assessment [Time Frame: Up to 35 months]
6. DC by Investigator's Assessment [Time Frame: Up to 35 months]
7. DOR by Investigator's Assessment [Time Frame: Up to 35 months]
8. TTR by Investigator's Assessment [Time Frame: Up to 35 months]
9. PFS by Investigator's Assessment [Time Frame: Up to 35 months]
10. Overall Survival (OS) [Time Frame: Up to 35 months]
11. Number of Participants Experiencing TEAEs [Time Frame: Up to 35 months]
12. Cmax of AMG 193 [Time Frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose]
13. Tmax of AMG 193 [Time Frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose]
14. AUC of AMG 193 [Time Frame: Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day15 pre-dose; Cycles 3-5: Day 1 pre-dose]
15. Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30 [Time Frame: Up to 12 months]
16. Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) [Time Frame: Up to 12 months]
17. Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) [Time Frame: Up to 12 months]
18. Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Time Frame: Up to 12 months]
19. Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G) [Time Frame: Up to 12 months]
Amgen K.K.
The Cancer Institute Hospital of JFCR, Institutional Review Board
3-8-31, Ariake, Koto-ku, Tokyo
Approval
Dec. 24, 2024
Yes
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
