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

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ClinicalTrials.gov Identifier: NCT03013218
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : March 22, 2024
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 March 22, 2024
Actual Study Start Date  ICMJE February 3, 2017
Actual Primary Completion Date February 1, 2022   (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 Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Official Title  ICMJE A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Brief Summary A phase 1, dose escalation study of evorpacept (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 evorpacept (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: Evorpacept (ALX148)
    Evorpacept (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: Evorpacept (ALX148)
    The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
    Intervention: Drug: Evorpacept (ALX148)
  • Experimental: Evorpacept (ALX148) + Pembrolizumab
    The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
    Interventions:
    • Drug: Evorpacept (ALX148)
    • Drug: Pembrolizumab
  • Experimental: Evorpacept (ALX148) + Trastuzumab
    The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
    Interventions:
    • Drug: Evorpacept (ALX148)
    • Drug: Trastuzumab
  • Experimental: Evorpacept (ALX148) + Rituximab
    The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
    Interventions:
    • Drug: Evorpacept (ALX148)
    • Drug: Rituximab
  • Experimental: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
    The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
    Interventions:
    • Drug: Evorpacept (ALX148)
    • Drug: Pembrolizumab
    • Drug: 5-FU + Cisplatin
  • Experimental: Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel
    The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
    Interventions:
    • Drug: Evorpacept (ALX148)
    • Drug: Trastuzumab
    • Drug: Ramucirumab + Paclitaxel
Publications * Lakhani NJ, Chow LQM, Gainor JF, LoRusso P, Lee KW, Chung HC, Lee J, Bang YJ, Hodi FS, Kim WS, Santana-Davila R, Fanning P, Squifflet P, Jin F, Kuo TC, Wan HI, Pons J, Randolph SS, Messersmith WA. Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study. Lancet Oncol. 2021 Dec;22(12):1740-1751. doi: 10.1016/S1470-2045(21)00584-2. Epub 2021 Nov 15.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 5, 2021)		 174
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)		 110
Estimated Study Completion Date  ICMJE December 1, 2024
Actual Primary Completion Date February 1, 2022   (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 information is only displayed when the study is recruiting subjects
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
Current Responsible Party ALX Oncology Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ALX Oncology Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ALX Oncology Inc.
Verification Date March 2024

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