30 Participants Needed

ACE2016 for Metastatic Tumors

Recruiting at 8 trial locations
SC
Overseen ByStephanie Chien
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Acepodia Biotech, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).

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.

Eligibility Criteria

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
My blood, kidney, liver, and heart are functioning well.
I am fully active or can carry out light work.
See 2 more

Exclusion Criteria

I have HIV, active hepatitis B, or hepatitis C.
I have active brain metastases.
I have been treated with a gene therapy targeting EGFR.
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: ACE2016 ONLY: 3 DOSESExperimental Treatment3 Interventions
ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.
Group II: ACE2016 ONLY: 1 DOSEExperimental Treatment3 Interventions
ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.
Group III: ACE2016 AND PEMBROLIZUMAB: 3 DOSESExperimental Treatment4 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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Acepodia Biotech, Inc.

Lead Sponsor

Trials
3
Recruited
80+
Unbiased ResultsWe believe in providing patients with all the options.
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