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

Phase 1

Active, not recruiting

• Conditions: Metastatic Cancer; NonHodgkin Lymphoma; Advanced Cancer; Solid Tumor
• Interventions: Drug: Evorpacept (ALX148); Drug: Pembrolizumab; Drug: Trastuzumab; Drug: Rituximab; Drug: Ramucirumab + Paclitaxel; Drug: 5-FU + Cisplatin

• Registration Number: NCT03013218
• Lead Sponsor: ALX Oncology Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-02-03
• Primary Completion: 2022-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy; or relapsed or refractory Non-Hodgkin lymphoma for whom no standard therapy is available..
• Adequate Bone Marrow Function.
• Adequate Renal & Liver Function.
• Adequate Performance Status

Exclusion Criteria

• Patients with known symptomatic CNS metastases or lepotomeningeal disease requiring steroids.
• Previous high-dose chemotherapy requiring allogenic stem cell rescue.
• Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting agent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evorpacept (ALX148) + Pembrolizumab	Evorpacept (ALX148)	The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel	Ramucirumab + Paclitaxel	The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum	5-FU + Cisplatin	The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
Evorpacept (ALX148)	Evorpacept (ALX148)	The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
Evorpacept (ALX148) + Trastuzumab	Evorpacept (ALX148)	The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
Evorpacept (ALX148) + Pembrolizumab	Pembrolizumab	The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum	Evorpacept (ALX148)	The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
Evorpacept (ALX148) + Rituximab	Evorpacept (ALX148)	The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel	Evorpacept (ALX148)	The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
Evorpacept (ALX148) + Trastuzumab	Trastuzumab	The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
Evorpacept (ALX148) + Rituximab	Rituximab	The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum	Pembrolizumab	The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel	Trastuzumab	The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities (Number of participants with a DLT)	Up to 28 days	Number of participants with a DLT

Trial Locations

Locations (10)

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

START-Midwest; 🇺🇸 Grand Rapids, Michigan, United States

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Severance Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States