Evorpacept for Advanced Cancers
(ASPEN-09 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of the drug evorpacept when combined with other cancer treatments for advanced cancers. One part of the trial targets individuals with HER2-positive metastatic breast cancer who have previously tried trastuzumab-deruxtecan but continue to experience cancer progression. The trial seeks participants with this type of breast cancer who are willing to try a new combination of treatments, including evorpacept, trastuzumab, and a choice of chemotherapy. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Do I need to stop my current medications for the trial?
Yes, you may need to stop certain medications before starting the trial. There is a required 'washout period' (time without taking certain medications) of 14 days or 5 half-lives for chemotherapy, hormonal therapy, radiation therapy, or small molecule anti-cancer therapy, and 28 days or 5 half-lives for immune or biologic therapies.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that evorpacept has been tested with other treatments for certain types of cancer. In earlier studies, patients with HER2-positive metastatic breast cancer received evorpacept along with trastuzumab and chemotherapy. These studies found that the treatment was generally well-tolerated, with most patients not experiencing severe side effects.
Some mild to moderate side effects were reported, such as tiredness, nausea, and low blood cell counts. These side effects are common with cancer treatments and were manageable for most patients.
Evorpacept has also been tested with drugs like zanidatamab in other studies, which also found no severe safety concerns with evorpacept.
Since the current trial is in its early stages, it focuses on learning more about the safety and optimal dose of evorpacept when used with other drugs. While early results are promising, researchers continue to study how well patients tolerate this treatment.12345Why do researchers think this study treatment might be promising?
Evorpacept is unique because it offers a new approach by targeting the CD47-SIRPα pathway, which acts as a "don't eat me" signal to the immune system. Unlike standard treatments for metastatic HER2+ breast cancer, which typically include combinations of chemotherapy and monoclonal antibodies like trastuzumab, Evorpacept enhances the ability of immune cells to attack cancer cells. Researchers are excited about this treatment because it could potentially improve the effectiveness of existing therapies by making cancer cells more susceptible to immune system attacks. This novel mechanism of action may lead to better outcomes for patients who have limited options with current treatments.
What evidence suggests that evorpacept might be an effective treatment for advanced cancers?
Research has shown that evorpacept might help treat HER2-positive metastatic breast cancer by blocking a protein called CD47, which cancer cells use to evade the immune system. One study demonstrated improvement in patients with HER2-positive cancer who had already received many treatments when they used evorpacept. In this trial, participants will receive a combination of evorpacept, trastuzumab, and a chemotherapy drug chosen by their physician. Previous studies suggest that adding evorpacept to standard treatments could increase overall response rates and enhance effectiveness against difficult-to-treat cancers.14678
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic cancers, specifically HER2+ breast cancer, colorectal cancer, and other types not open at study start. Participants must have measurable disease and be suitable for chemotherapy. Those with brain metastases, immune diseases or poor organ function are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive evorpacept in combination with anti-cancer therapies until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision, or study termination by the sponsor
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to receive study treatment in an open-label extension if applicable
What Are the Treatments Tested in This Trial?
Interventions
- Evorpacept
Trial Overview
Evorpacept (ALX148) is being tested in combination with various anti-cancer therapies like Capecitabine and Trastuzumab. The study includes different groups: one group receives Evorpacept plus standard care; another gets only standard care; there's also a dose escalation phase for colorectal cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
* 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
ALX Oncology Inc.
Lead Sponsor
Citations
1.
ir.alxoncology.com
ir.alxoncology.com/news-releases/news-release-details/alx-oncology-announces-new-data-demonstrating-evorpaceptRelease Details
"These data suggest that HER2-positive patients whose cancer has been heavily pretreated may benefit from CD47 inhibition via evorpacept's ...
2.
onclive.com
onclive.com/view/zanidatamab-plus-evorpacept-shows-early-activity-tolerability-in-pretreated-her2-breast-cancerZanidatamab Plus Evorpacept Shows Early Activity ...
Although efficacy outcomes were most pronounced in patients with HER2-positive disease, the cORR and median PFS were 20.0% (95% CI, 4.3%-48.1%) ...
3.
aacrjournals.org
aacrjournals.org/clincancerres/article/31/12_Supplement/PS8-09/753445/Abstract-PS8-09-Zanidatamab-in-combination-withAbstract PS8-09: Zanidatamab in combination with evorpacept ...
Zanidatamab in combination with evorpacept in HER2-positive and HER2-low metastatic breast cancer: Results from a phase 1b/2 study [abstract].
A phase 2/3 study of evorpacept (ALX148), a CD47 ...
Results: Among the entire randomized population (N=127) the ORR was 40.3% (Evo-TRP) and 26.6% (TRP), respectively. The difference between Evo- ...
5.
targetedonc.com
targetedonc.com/view/evorpacept-shows-promising-efficacy-in-her2-positive-gastric-and-gej-cancersEvorpacept Shows Promising Efficacy in HER2-Positive ...
The ASPEN-06 trial found that adding evorpacept to trastuzumab, ramucirumab, and paclitaxel significantly improved overall response rates ...
623TiP A single-arm phase 2 study of evorpacept in ...
A single arm phase 2 study of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer (mBC) ( ...
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) ...
This study is being done to find out if zanidatamab when given with evorpacept (ALX148) is safe and can treat patients with advanced (locally advanced [ ...
ASPEN-03 and ASPEN-04 Phase 2 Trials Evaluating ...
In ASPEN-03 and ASPEN-04 trials, efficacy data do not support advancing evorpacept in combination with Merck's anti-PD-1 therapy, ...
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