ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
Purpose
The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies: - Metastatic HER2+ breast cancer (MBC) - single-arm substudy evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting. - Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting. - Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.
Condition
- Breast Cancer, Metastatic
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
(all substudies): - Participants must have at least one measurable lesion as defined by RECIST v1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1. - Life expectancy of at least 3 months - Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible which do not constitute a safety risk by Investigator judgment MBC substudy: - Histologically confirmed invasive HER2 positive breast cancer - Available tumor tissue (FFPE slides or block). A fresh biopsy is preferred but optional. - Received at least one prior line of therapy including T-DXd for locally advanced/metastatic HER2 positive breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease. - Progressed on or following the most recent line of therapy - Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine) - LVEF ≥50% - Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation - Adequate liver function: - Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome); - Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).
Exclusion Criteria
(all substudies): - Participants with known CNS metastases unless treated and stable prior to enrollment - Following anti-cancer therapy with insufficient washout before C1D1: 1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of C1D1. 2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of C1D1) - Prior exposure to any anti-CD47 or anti-SIRPα agent. - History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction. - Had an allogeneic tissue/solid organ transplant. - Any active, unstable cardiovascular disease - Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients). - Has an active autoimmune disease that has required systemic treatment in past 2 years MBC substudy: - Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen - Other primary malignancy within 2 years - Any condition that would be contraindicated to receiving trastuzumab
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- This is a basket study with substudies based on indications.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer |
- Evorpacept (IV) - once every 3 weeks (Q3W) - Trastuzumab (IV) - once every 3 weeks (Q3W) - Chemotherapy (physician selects one of the following): - Capecitabine (Oral) 14 days every 3 weeks - Eribulin (IV) twice every 3 weeks - Gemcitabine (IV) twice every 3 weeks - Paclitaxel (IV) once every 3 weeks (Q3W) - Vinolrebine (IV) twice every 3 weeks |
|
Recruiting Locations
Tucson 5318313, Arizona 5551752 85719
Denver 5419384, Colorado 5417618 80218
Golden 5423294, Colorado 5417618 80401
Grand Junction 5423573, Colorado 5417618 81501
Washington D.C. 4140963, District of Columbia 4138106 20037
Ann Arbor 4984247, Michigan 5001836 48109
Saint Louis Park 5045021, Minnesota 5037779 55426
Study Coordinator
Omaha 5074472, Nebraska 5073708 68130
Study Coordinator
402-334-4773
Canton 5149222, Ohio 5165418 44718
Study Coordinator
Dallas 4684888, Texas 4736286 75390
Houston 4699066, Texas 4736286 77030
More Details
- NCT ID
- NCT07007559
- Status
- Recruiting
- Sponsor
- ALX Oncology Inc.
Detailed Description
Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision or study termination by the sponsor. Not all substudies may be active and/or open to enrollment at a given time. Not all study centers may be participating in every substudy. MBC substudy will be the first to enroll - thus the information reflected in the enrollment number, arms/interventions, outcome measures, and eligibility criteria only include MBC at this time.