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

• ClinicalTrials.gov Identifier: NCT03013218
• Recruitment Status: Active, not recruiting
• First Posted: January 6, 2017
• Last Update Posted: May 6, 2021
• Sponsor: ALX Oncology Inc.
• Information provided by (Responsible Party): ALX Oncology Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Metastatic Cancer; Solid Tumor; Advanced Cancer; NonHodgkin Lymphoma	Drug: ALX148; Drug: Pembrolizumab; Drug: Trastuzumab; Drug: Rituximab; Drug: Ramucirumab + Paclitaxel; Drug: 5-FU + Cisplatin	Phase 1

Detailed Description:

This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose, dose-escalation, safety, PK, and PD study of 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 174 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Dose Escalation Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
• Actual Study Start Date: February 3, 2017
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: ALX148; The Part 1 Dose Escalation: ALX148 infusions will be administered weekly or every two weeks.	Drug: ALX148; ALX148
Experimental: ALX148 + Pembrolizumab; The Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.	Drug: ALX148; ALX148; Drug: Pembrolizumab; Keytruda
Experimental: ALX148 + Trastuzumab; The Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.	Drug: ALX148; ALX148; Drug: Trastuzumab; Herceptin
Experimental: ALX148 + Rituximab; The Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with rituximab infusions.	Drug: ALX148; ALX148; Drug: Rituximab; Rituxan
Experimental: ALX148 + Pembrolizumab + 5FU + Platinum; The Part 2 Dose Escalation: ALX148 infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.	Drug: ALX148; ALX148; Drug: Pembrolizumab; Keytruda; Drug: 5-FU + Cisplatin; Standard of care chemotherapy
Experimental: ALX148 + Trastuzumab + Ramucirumab + Paclitaxel; The Part 2 Dose Escalation: ALX148 infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.	Drug: ALX148; ALX148; Drug: Trastuzumab; Herceptin; Drug: Ramucirumab + Paclitaxel; Standard of care chemotherapy

Outcome Measures

Primary Outcome Measures :

1. Dose-limiting toxicities (Number of participants with a DLT) [ Time Frame: Up to 28 days ]
   Number of participants with a DLT

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Colorado

University of Colorado Denver

Denver, Colorado, United States, 80045

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Michigan

START-Midwest

Grand Rapids, Michigan, United States, 49503

United States, Washington

Seattle Cancer Care Alliance

Seattle, Washington, United States, 98109

Korea, Republic of

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of

Samsung Medical Center

Seoul, Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Severance Hospital, Yonsei University

Seoul, Korea, Republic of

Sponsors and Collaborators

ALX Oncology Inc.

More Information

• Responsible Party: ALX Oncology Inc.
• ClinicalTrials.gov Identifier: NCT03013218
• Other Study ID Numbers: AT148001
• First Posted: January 6, 2017
• Last Update Posted: May 6, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ALX Oncology Inc.:

Neoplasms; CD47; SIRPα; ALX148

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Paclitaxel; Rituximab; Pembrolizumab; Trastuzumab; Ramucirumab; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents