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Trial record 1 of 1 for:    NCT03013218
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A Study of Evorpacept (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013218
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

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

Condition or disease Intervention/treatment Phase
Metastatic Cancer Solid Tumor Advanced Cancer NonHodgkin Lymphoma Drug: Evorpacept (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 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 Design
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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 Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Actual Study Start Date : February 3, 2017
Actual Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Evorpacept (ALX148)
The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
 Drug: Evorpacept (ALX148)
Evorpacept (ALX148)
Experimental: Evorpacept (ALX148) + Pembrolizumab
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
 Drug: Evorpacept (ALX148)
Evorpacept (ALX148)

Drug: Pembrolizumab
Keytruda
Experimental: Evorpacept (ALX148) + Trastuzumab
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
 Drug: Evorpacept (ALX148)
Evorpacept (ALX148)

Drug: Trastuzumab
Herceptin
Experimental: Evorpacept (ALX148) + Rituximab
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
 Drug: Evorpacept (ALX148)
Evorpacept (ALX148)

Drug: Rituximab
Rituxan
Experimental: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
 Drug: Evorpacept (ALX148)
Evorpacept (ALX148)

Drug: Pembrolizumab
Keytruda

Drug: 5-FU + Cisplatin
Standard of care chemotherapy
Experimental: Evorpacept (ALX148) + Trastuzumab + 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.
 Drug: Evorpacept (ALX148)
Evorpacept (ALX148)

Drug: Trastuzumab
Herceptin

Drug: Ramucirumab + Paclitaxel
Standard of care chemotherapy


Outcome Measures
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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
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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.


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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
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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


Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Evorpacept
Additional relevant MeSH terms:
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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
Immune Checkpoint Inhibitors