Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Alexo Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Alexo Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03013218
First received: December 15, 2016
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and lymphoma

Condition Intervention Phase
Metastatic Cancer
Solid Tumor
Advanced Cancer
NonHodgkin Lymphoma
Drug: ALX148
Drug: Atezolizumab
Drug: Trastuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1, Dose Escalation Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma

Resource links provided by NLM:


Further study details as provided by Alexo Therapeutics, Inc.:

Primary Outcome Measures:
  • Dose-limiting toxicities (Number of participants with a DLT) [ Time Frame: Up to 28 days ]
    Number of participants with a DLT


Estimated Enrollment: 110
Actual Study Start Date: February 3, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALX148
The Part 1 Dose Escalation: ALX148 infusions will be administered weekly or every two weeks.
Drug: ALX148
Experimental: ALX148 + Atezolizumab
The Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with atezolizumab infusions administered every three weeks.
Drug: ALX148 Drug: Atezolizumab
Other Name: Tecentriq
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 Drug: Trastuzumab
Other Name: Herceptin

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 110 adult patients are expected to be enrolled in the study.
  Eligibility

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 that is resistant to standard therapy or for which no standard therapy is available; 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 stem cell rescue.
  • Prior irradiation to >25% of the bone marrow.
  • Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting agent.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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   
Principal Investigator: Wells Messersmith, MD, FACP         
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06520
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   
Principal Investigator: Nehal Lakhani, MD, PhD         
Sponsors and Collaborators
Alexo Therapeutics, Inc.
  More Information

Responsible Party: Alexo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03013218     History of Changes
Other Study ID Numbers: AT148001
Study First Received: December 15, 2016
Last Updated: March 22, 2017
Individual Participant Data  
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
Trastuzumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017