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

Primary Purpose

Metastatic Cancer, Solid Tumor, Advanced Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Evorpacept (ALX148)
Pembrolizumab
Trastuzumab
Rituximab
Ramucirumab + Paclitaxel
5-FU + Cisplatin
Sponsored by
ALX Oncology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Neoplasms, CD47, SIRPα, ALX148, Evorpacept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Denver
  • Yale University
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute
  • START-Midwest
  • Seattle Cancer Care Alliance
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Evorpacept (ALX148)

Evorpacept (ALX148) + Pembrolizumab

Evorpacept (ALX148) + Trastuzumab

Evorpacept (ALX148) + Rituximab

Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum

Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel

Arm Description

The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.

The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.

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

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

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

The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.

Outcomes

Primary Outcome Measures

Dose-limiting toxicities (Number of participants with a DLT)
Number of participants with a DLT

Secondary Outcome Measures

Full Information

First Posted
December 15, 2016
Last Updated
August 11, 2023
Sponsor
ALX Oncology Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03013218
Brief Title
A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Official Title
A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALX Oncology Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Solid Tumor, Advanced Cancer, NonHodgkin Lymphoma
Keywords
Neoplasms, CD47, SIRPα, ALX148, Evorpacept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evorpacept (ALX148)
Arm Type
Experimental
Arm Description
The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
Arm Title
Evorpacept (ALX148) + Pembrolizumab
Arm Type
Experimental
Arm Description
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
Arm Title
Evorpacept (ALX148) + Trastuzumab
Arm Type
Experimental
Arm Description
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
Arm Title
Evorpacept (ALX148) + Rituximab
Arm Type
Experimental
Arm Description
The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
Arm Title
Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
Arm Type
Experimental
Arm Description
The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
Arm Title
Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel
Arm Type
Experimental
Arm Description
The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
Intervention Type
Drug
Intervention Name(s)
Evorpacept (ALX148)
Intervention Description
Evorpacept (ALX148)
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Keytruda
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
Herceptin
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituxan
Intervention Type
Drug
Intervention Name(s)
Ramucirumab + Paclitaxel
Intervention Description
Standard of care chemotherapy
Intervention Type
Drug
Intervention Name(s)
5-FU + Cisplatin
Intervention Description
Standard of care chemotherapy
Primary Outcome Measure Information:
Title
Dose-limiting toxicities (Number of participants with a DLT)
Description
Number of participants with a DLT
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
START-Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34793719
Citation
Lakhani NJ, Chow LQM, Gainor JF, LoRusso P, Lee KW, Chung HC, Lee J, Bang YJ, Hodi FS, Kim WS, Santana-Davila R, Fanning P, Squifflet P, Jin F, Kuo TC, Wan HI, Pons J, Randolph SS, Messersmith WA. Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study. Lancet Oncol. 2021 Dec;22(12):1740-1751. doi: 10.1016/S1470-2045(21)00584-2. Epub 2021 Nov 15.
Results Reference
derived

Learn more about this trial

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

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