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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013218
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

Tracking Information
First Submitted Date  ICMJE December 15, 2016
First Posted Date  ICMJE January 6, 2017
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE February 3, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Dose-limiting toxicities (Number of participants with a DLT) [ Time Frame: Up to 28 days ]
Number of participants with a DLT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma
Official Title  ICMJE A Phase 1, Dose Escalation Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma
Brief Summary A phase 1, dose escalation study of 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Cancer
  • Solid Tumor
  • Advanced Cancer
  • NonHodgkin Lymphoma
Intervention  ICMJE
  • Drug: ALX148
    ALX148
  • Drug: Pembrolizumab
    Keytruda
  • Drug: Trastuzumab
    Herceptin
  • Drug: Rituximab
    Rituxan
  • Drug: Ramucirumab + Paclitaxel
    Standard of care chemotherapy
  • Drug: 5-FU + Cisplatin
    Standard of care chemotherapy
Study Arms  ICMJE
  • Experimental: ALX148
    The Part 1 Dose Escalation: ALX148 infusions will be administered weekly or every two weeks.
    Intervention: Drug: 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.
    Interventions:
    • Drug: ALX148
    • Drug: Pembrolizumab
  • Experimental: ALX148 + Trastuzumab
    The Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
    Interventions:
    • Drug: ALX148
    • Drug: Trastuzumab
  • Experimental: ALX148 + Rituximab
    The Part 2 Dose Escalation/Expansion: ALX148 infusions will be administered weekly or every two weeks in combination with rituximab infusions.
    Interventions:
    • Drug: ALX148
    • Drug: Rituximab
  • 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.
    Interventions:
    • Drug: ALX148
    • Drug: Pembrolizumab
    • Drug: 5-FU + Cisplatin
  • 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.
    Interventions:
    • Drug: ALX148
    • Drug: Trastuzumab
    • Drug: Ramucirumab + Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2019)
184
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
110
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sophia Randolph, MD, PhD 650-466-7125 info@alxoncology.com
Contact: Philip Fanning, PhD 650-466-7125 info@alxoncology.com
Listed Location Countries  ICMJE Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03013218
Other Study ID Numbers  ICMJE AT148001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ALX Oncology Inc.
Study Sponsor  ICMJE ALX Oncology Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ALX Oncology Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP