A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
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ClinicalTrials.gov Identifier: NCT03013218 |
Recruitment Status :
Recruiting
First Posted : January 6, 2017
Last Update Posted : January 15, 2021
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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 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: ALX148
The Part 1 Dose Escalation: ALX148 infusions will be administered weekly or every two weeks.
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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 |
- Dose-limiting toxicities (Number of participants with a DLT) [ Time Frame: Up to 28 days ]Number of participants with a DLT

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy 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.

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
Contact: Sophia Randolph, MD, PhD | 650-466-7125 | info@alxoncology.com | |
Contact: Philip Fanning, PhD | 650-466-7125 | info@alxoncology.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms CD47 SIRPα ALX148 |
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 |