ACE2016 for Metastatic Tumors

Recruiting at 11 trial locations

Overseen By Stephanie Chien

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Acepodia Biotech, Inc.

Disqualifiers: CNS metastases, CNS disorder, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy called ACE2016 for treating solid tumors that have spread or cannot be removed and have a specific protein called EGFR. It aims to evaluate the safety and effectiveness of this treatment, either alone or with another drug, pembrolizumab. Suitable participants have tumors that have not responded to at least two treatments, including one targeted type, and have a measurable tumor. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ACE2016, a new cell therapy, is being tested for safety and tolerability in treating tumors with a specific protein called EGFR. This marks the first trial of ACE2016 in humans, so no previous human data exists. The trial's main goal is to assess the treatment's safety and identify any side effects.

When combined with pembrolizumab, a medicine already used for some cancers, past studies have shown that pembrolizumab can cause side effects like tiredness, skin rash, and fever. However, it is generally considered safe for many patients. Since ACE2016 is new, its safety in combination with pembrolizumab remains under study.

In summary, ACE2016 is in the early stages of human testing. The current focus is on safety, and any side effects will be closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ACE2016 for metastatic tumors because it represents a novel approach to treatment. Unlike traditional chemotherapy or targeted therapies, ACE2016 works by escalating doses of a new active ingredient, potentially enhancing the immune system's ability to fight cancer cells. The combination arm with pembrolizumab, an established immunotherapy, could amplify its effectiveness, offering a promising new option for patients with limited responses to current treatments. This innovative mechanism could lead to more effective and personalized cancer care.

What evidence suggests that this trial's treatments could be effective for metastatic tumors?

Research has shown that ACE2016, a type of cell therapy, holds potential for treating solid tumors with the EGFR protein. In lab studies, ACE2016 becomes highly active upon encountering these target cells and can help slow tumor growth. This suggests it might be useful for treating tumors with the EGFR protein.

In this trial, some participants will receive ACE2016 alone, either as a single dose or in three doses. Another group will receive ACE2016 combined with pembrolizumab, a drug already used for some cancers. Pembrolizumab, alone or with chemotherapy, has been proven to improve survival rates and slow cancer progression. This combination aims to leverage the strengths of both treatments for potentially better outcomes in advanced tumors. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or widespread solid tumors that have a protein called EGFR. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

At least one measurable lesion as defined by RECIST v1.1 criteria

Oxygen saturation via pulse oximeter ≥92% at rest on room air

My blood, kidney, liver, and heart are functioning well.

Exclusion Criteria

I have HIV, active hepatitis B, or hepatitis C.

I have active brain metastases.

Pregnant or lactating female

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a lymphodepleting regimen followed by escalating or recommended doses of ACE2016, with or without pembrolizumab

12 weeks

Follow-up

Participants are monitored for safety, tolerability, and efficacy, including changes in clinical laboratory tests and vital signs

1 year

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• ACE2016

Trial Overview The study tests ACE2016, an experimental cell therapy from healthy donors, alongside Fludarabine and Cyclophosphamide drugs, with or without Pembrolizumab. It's the first time this combination is being tried in humans to see if it's safe and works against these tumors.

How Is the Trial Designed?

Group I: ACE2016 ONLY: 3 DOSES Experimental Treatment 3 Interventions

ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.

Group II: ACE2016 ONLY: 1 DOSE Experimental Treatment 3 Interventions

ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.

Group III: ACE2016 AND PEMBROLIZUMAB: 3 DOSES Experimental Treatment 4 Interventions

ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.

ACE2016 is already approved in United States for the following indications:

Approved in United States as ACE2016 for:

• Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Who Is Running the Clinical Trial?

Acepodia Biotech, Inc.

Lead Sponsor

Trials

3

Recruited

80+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11651430/

Pembrolizumab alone or combined with chemotherapy versus ... Conclusions: Pembrolizumab alone or combined with chemotherapy indicates an effective and safe treatment for metastatic cancer. Pembrolizumab ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11273333/

Comparative long-term outcomes of pembrolizumab plus ... The median survival time for OS was 22.54 months for the combination of pembrolizumab and chemotherapy, 22.62 months for pembrolizumab ...

3. merck.com merck.com/news/five-year-data-for-mercks-keytruda-pembrolizumab-plus-chemotherapy-showed-sustained-survival-benefit-versus-chemotherapy-alone-in-two-studies-for-metastatic-non-small-cell-lung-cancer-nsclc/

Five-Year Data for Merck's KEYTRUDA® (pembrolizumab ... Five-year overall survival rate of 19.4% and 18.4% for KEYTRUDA plus chemotherapy in KEYNOTE-189 and KEYNOTE-407, respectively. In first-line metastatic ...

4. oncpracticemanagement.com oncpracticemanagement.com/issues/2021/april-2021-vol-11-no-4/pembrolizumab-plus-chemotherapy-combo-improves-progression-free-survival-in-metastatic-tnbc

Pembrolizumab plus Chemotherapy Combo Improves ... “Pembrolizumab plus chemotherapy achieved a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy ...

5. valuebasedcancer.com valuebasedcancer.com/issues/2016/november-2016-vol-7-no-10/adding-pembrolizumab-to-chemotherapy-as-first-line-treatment-significantly-improves-outcomes-in-patients-with-advanced-nsclc

Adding Pembrolizumab to Chemotherapy as First-Line ... “The response rate is nearly doubled by adding pembrolizumab to chemotherapy, and the risk for progression or death is nearly halved. There is no difference in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8830697/

Retrospective analysis of clinical trial safety data ... We analyzed over ten thousand adverse event reports from Keynote clinical trials of pembrolizumab for various cancer indications with or without co-occurring ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14342-2

Retrospective analysis of pembrolizumab-related adverse ... This study aimed to analyze the characteristics of adverse reactions in cancer patients treated with Pembrolizumab based on the US Food and Drug Administration ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7226447/

Public Adverse Event Data Insights into the Safety of ... Results from clinical studies have shown that treatment with the PD-1 inhibitors Pembrolizumab and Nivolumab provides improved response and ...

9. europeanreview.org europeanreview.org/wp/wp-content/uploads/9213-9225.pdf

Real-world data on efficacy and safety of pembrolizumab in ... A total of 18 patients received second-line treatment of metastatic disease after progression to pembrolizumab. Cisplatin with pemetrexed (8.

10. dana-farber.org dana-farber.org/clinical-trials/22-076

An Open-label Phase IA/IB/II Study (PRESERVE-001) Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination with Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open-label ...