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

Part of paid clinical trials in Denver, Colorado.

Sponsor
ALX Oncology Inc.
Study ID
NCT03013218
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer
  • Metastatic Cancer
  • NonHodgkin Lymphoma
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evorpacept (ALX148) — DRUG
    Evorpacept (ALX148)
  • Pembrolizumab — DRUG
    Keytruda
  • Trastuzumab — DRUG
    Herceptin
  • Rituximab — DRUG
    Rituxan
  • Ramucirumab + Paclitaxel — DRUG
    Standard of care chemotherapy
  • 5-FU + Cisplatin — DRUG
    Standard of care chemotherapy

Study Details

A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma

Key Dates

Start date
Feb 3, 2017
Status verified
Jul 2025
Primary completion
Feb 1, 2022
Completion
Jul 8, 2025

Study Design

Enrollment
174 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evorpacept (ALX148)
    The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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

Locations (6)

FacilityCityStateZIPSite coordinators
University of Colorado DenverDenverColorado80045-
Yale UniversityNew HavenConnecticut06520-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
START-MidwestGrand RapidsMichigan49503-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Denver, CO

By research site
University of Colorado Denver· Denver, COYale University· New Haven, CTDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MASTART-Midwest· Grand Rapids, MISeattle Cancer Care Alliance· Seattle, WA

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