NCT03013218

A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: ALX Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma

Detailed description

This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose, dose-escalation, safety, PK, and PD study of evorpacept (ALX148). The phase 1 protocol will have 2 parts: a single agent dose escalation phase (Part 1) and a combination therapy phase (Part 2). Part 2 will include an initial dose escalation portion followed by a dose expansion portion. Approximately 184 adult patients are expected to be enrolled in the study.

Conditions

• Metastatic Cancer
• Solid Tumor
• Advanced Cancer
• NonHodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Evorpacept (ALX148)	Evorpacept (ALX148)
DRUG	Pembrolizumab	Keytruda
DRUG	Trastuzumab	Herceptin
DRUG	Rituximab	Rituxan
DRUG	Ramucirumab + Paclitaxel	Standard of care chemotherapy
DRUG	5-FU + Cisplatin	Standard of care chemotherapy

Timeline

• Start date: 2017-02-03
• Primary completion: 2022-02-01
• Completion: 2025-07-08
• First posted: 2017-01-06
• Last updated: 2025-08-01

Locations

10 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study