Study Complete
Sponsor ID
20220073

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

Sponsor ID
20220073
Clinicaltrials.gov ID
NCT05800964
EUCTIS ID
N/A
EudraCT ID
2022-502867-39

Study Details

The primary objective of this study is to:

  • Evaluate the safety and tolerability of AMG 305 in adult participants
  • Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
  • Determine the recommended phase 2 dose (RP2D)

Additional Study Details

Phase
Phase 1
Product
AMG 305
Type
Interventional
Masking
None (Open Label)
Enrollment
37
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)

Timeframe: Day 1 to Day 28

Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Up to a maximum of 2 years

Percentage of Participants who Experience Treatment-Related Adverse Events

Timeframe: Up to a maximum of 2 years

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of AMG 305

Timeframe: Up to a maximum of 2 years

Minimum Serum Concentration (Cmin) of AMG 305

Timeframe: Up to a maximum of 2 years

Area Under the Concentration-Time Curve (AUC) of AMG 305

Timeframe: Up to a maximum of 2 years

Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Timeframe: Up to a maximum of 2 years

ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)

Timeframe: Up to a maximum of 2 years

Duration of Response (DOR)

Timeframe: Up to a maximum of 2 years

Time to Progression

Timeframe: Up to a maximum of 2 years

Progression-Free Survival (PFS)

Timeframe: Up to a maximum of 2 years

Overall Survival (OS) at 1 Year

Timeframe: 1 year

OS at 2 Years

Timeframe: 2 years

Locations

Location
Status
Contact Us
Location
Peter MacCallum Cancer Centre
Melbourne, VIC, Australia, 3000
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Next Oncology
San Antonio, TX, United States, 78229
Status
Recruiting
Location
New York University Cancer Institute
New York, NY, United States, 10016
Status
Recruiting
Location
Asan Medical Center
Seoul, Republic of Korea, 05505
Status
Recruiting
Location
Seoul National University Hospital
Seoul, Republic of Korea, 03080
Status
Recruiting
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