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A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma

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ClinicalTrials.gov Identifier: NCT03013218
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Alexo Therapeutics, Inc.

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 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 142 adult patients are expected to be enrolled in the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 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
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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 administered every three weeks.
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 administered every three weeks.
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 administered once weekly for 4 doses followed by once monthly for 8 doses.
Drug: ALX148
ALX148
Drug: Rituximab
Rituxan



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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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
Contact: Sophia Randolph, MD, PhD 650-466-7125 info@alexotherapeutics.com
Contact: Philip Fanning, PhD 650-466-7125 info@alexotherapeutics.com

Locations
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 Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachel Annese    617-724-6634    rannese2@mgh.harvard.edu   
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 Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yukyung Shin    82-2-6072-5220      
Sponsors and Collaborators
Alexo Therapeutics, Inc.

Responsible Party: Alexo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03013218     History of Changes
Other Study ID Numbers: AT148001
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
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

Keywords provided by Alexo Therapeutics, Inc.:
Neoplasms
CD47
SIRPα
ALX148

Additional relevant MeSH terms:
Lymphoma
Neoplasm Metastasis
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Pembrolizumab
Rituximab
Trastuzumab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents