Clinical Trial - NCT03013218

       

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

Recruiting

Sponsor: ALX Oncology Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03013218

Protocol Info

Short Description: Phase 1 of ALX148 in ASTs and Lymphoma
Long Description: A Phase 1, Dose Escalation Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma
MGH Status: Closed
Sponsor: Alexo Therapeutics Inc.
Disease Program: Phase I

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and lymphoma
Condition Title Intervention Phase
Metastatic Cancer Solid Tumor Advanced Cancer NonHodgkin Lymphoma ALX148 Pembrolizumab Trastuzumab Rituximab Ramucirumab + Paclitaxel 5-FU + Cisplatin Phase 1
Study Type Interventional
Official Title A Phase 1, Dose Escalation Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

Primary Outcome Measures

Dose-limiting toxicities (Number of participants with a DLT) [Time Frame: Up to 28 days] [Designated as safety issue: ]


Secondary Outcome Measures

Estimated Enrollment: 184
Study Start Date: February 2017
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: March 2021
Arms Assigned Interventions

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: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: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: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: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:Ramucirumab + Paclitaxel
Standard of care chemotherapy

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT03013218

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

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03013218
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by ALX Oncology Inc.:

Neoplasms

CD47

SIRPa

ALX148

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Paclitaxel

Cisplatin

Rituximab

Pembrolizumab

Trastuzumab

Ramucirumab

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on February 25, 2021