Study Complete
Sponsor ID
20190131

Study of AMG 650 in Adult Participants with Advanced Solid Tumors

Sponsor ID
20190131
Clinicaltrials.gov ID
NCT04293094
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
66
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 12 months

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 24 months

Number of Participants with Serious Adverse Events (SAEs)

Timeframe: Up to 24 months

Number of Participants with Treatment-related Adverse Events

Timeframe: Up to 24 months

Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement

Timeframe: Up to 24 months

Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement

Timeframe: Up to 24 months

Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests

Timeframe: Up to 24 months

Secondary Outcome Measures

Objective Response Rate (ORR)

Timeframe: Up to 24 months

Duration of Response (DOR)

Timeframe: Up to 24 months

Progression-free Survival (PFS)

Timeframe: Up to 24 months

Clinical Benefit Rate (CBR)

Timeframe: Up to 24 months

Time to Response (TTR)

Timeframe: Up to 24 months

Time to Progression (TTP)

Timeframe: Up to 24 months

Overall Survival (OS)

Timeframe: Up to 24 months

Maximum Plasma Concentration (Cmax) of AMG 650

Timeframe: Up to 24 months

Time to Maximum Plasma Concentration (Tmax) of AMG 650

Timeframe: Up to 24 months

Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650

Timeframe: Up to 24 months

Locations

Location
Status
Contact Us
Location
Sarcoma Oncology Research Center LLC
Santa Monica, CA, United States, 90403
Status
Recruiting
Location
Washington University
St. Louis, MO, United States, 63110-1093
Status
Recruiting
Location
The Queen Elizabeth Hospital
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles, CA, United States, 90025
Status
Recruiting
Location
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
Location
Sarah Cannon Research Institute
Nashville, TN, United States, 37203
Status
Recruiting
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