Study Complete
Sponsor ID
20220127

A Phase 1/2 Study of Anvumetostat in Combination with IDE397 in Participants with Advanced Methylthioadenosine Phosphorylase (MTAP)-null Solid Tumors

Sponsor ID
20220127
Clinicaltrials.gov ID
NCT05975073
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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 Anvumetostat 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 anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 193
Type
Interventional
Masking
None (Open Label)
Enrollment
53
Additional Study Details

Protocol Summary

Primary Outcome Measures

Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)

Timeframe: Day 1 up to Day 21

Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Day 1 up to approximately 2.5 years

Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Day 1 up to approximately 2.5 years

Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Timeframe: Day 1 up to approximately 2.5 years

Secondary Outcome Measures

Part 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Part 1 and 2: Cmax of IDE397

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Part 1 and 2: Tmax of IDE397

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of Anvumetostat

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of Anvumetostat

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Parts 1 and 2: AUC After Single Dose of IDE397

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Parts 1 and 2: AUC After Multiple Doses of IDE397

Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Parts 1: Overall Response per RECIST 1.1

Timeframe: Day 1 up to end-of-study (EOS) (approximately 2.5 years)

Parts 1 and 2: Disease Control Rate

Timeframe: Day 1 up to EOS (approximately 2.5 years)

Parts 1 and 2: Time to Response (TTR)

Timeframe: Day 1 up to EOS (approximately 2.5 years)

Parts 1 and 2: Duration of Response (DOR)

Timeframe: Day 1 up to EOS (approximately 2.5 years)

Parts 1 and 2: Duration of Stable Disease

Timeframe: Day 1 up to EOT (approximately 6 months)

Parts 1 and 2: Progression-free Survival (PFS)

Timeframe: Day 1 up to EOS (approximately 2.5 years)

Parts 1 and 2: Overall Survival (OS)

Timeframe: Day 1 up to EOS (approximately 2.5 years)

Part 2: Number of Participants Experiencing TEAEs

Timeframe: Day 1 up to approximately 2.5 years

Part 2: Number of Participants Experiencing SAEs

Timeframe: Day 1 up to approximately 2.5 years

Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood

Timeframe: Baseline (Day 1) to EOT plus 30 days (approximately 7 months)

Locations

Location
Status
Contact Us
Location
Next Oncology
Irving, TX, United States, 75039
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91090
Status
Recruiting
Location
Prisma Health Upstate
Greenville, SC, United States, 29605
Status
Recruiting
Location
Community Health Network MD Anderson Cancer Center - North
Indianapolis, IN, United States, 46250
Status
Recruiting
Location
The Queen Elizabeth Hospital
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
Monash Medical Centre
Clayton, VIC, Australia, 3168
Status
Recruiting
Showing {first} - {last} of {total} Results