Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013218
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 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 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013218


Contacts
Layout table for location contacts
Contact: Sophia Randolph, MD, PhD 650-466-7125 info@alxoncology.com
Contact: Philip Fanning, PhD 650-466-7125 info@alxoncology.com

Locations
Layout table for location information
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Matt O'Hern    720-848-0523    matthew.ohern@ucdenver.edu   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Caroline Hotchkiss, MPH    203-737-5228    caroline.hotchkiss@yale.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Justin Gainor, MD    617-724-4000      
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Frank Hodi, MD    617-632-5053      
United States, Michigan
START-Midwest Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathy Estkowski, BS, CCRP    616-954-5554    kathy.estkowski@start.stoh.com   
Contact: Yvette C Cole, RN, BSN, OCN    616-954-5554    yvette.cole@start.stoh.com   
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Erica Peters, CCRC    206-606-7551    phase1@u.washington.edu   
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Keun-Wook Lee    82-31-787-7003    hmodoctor@snubh.org   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jeeyun Lee    82-2-3410-1779    jyun.lee@samsung.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yung-Jue Bang    82-2-2072-2390    bangyj@snu.ac.kr   
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of
Contact: Hyun Chung    82-2-2228-8132    UNCHUNG8@yuhs.ac   
Sponsors and Collaborators
ALX Oncology Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT03013218    
Other Study ID Numbers: AT148001
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for 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