Locally Advanced Solid TumorPhase 1NCT06415487
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
A Phase 1 study testing Cyclophosphamide, Fludarabine and ACE2016 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Acepodia Biotech, Inc. at 9 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- Cyclophosphamide, Fludarabine and ACE2016
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 22 Aug 2024to 27 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)
- At least one measurable lesion as defined by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate hematologic and renal, hepatic and cardiac function
- Oxygen saturation via pulse oximeter ≥92% at rest on room air
Who cannot join
- Prior treatment with a genetically modified cell therapy product targeting EGFR
- History of allogeneic transplantation
- Subjects with active CNS metastases
- History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)
- Clinically significant active infection
- Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
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- History of malignancies with the exception of certain treated malignancies with no evidence of disease.
- Primary immunodeficiency disorder
- Pregnant or lactating female
- Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
Taiwan5 sites, 5 recruiting
- Not yet recruiting
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Zhonghe District, 235
Taipei Medical University
Kang-Yun Lee, MD
- Not yet recruiting
Taichung Veteran General Hospital
Taichung, 40705
Taichung Veteran General Hospital
Kuan-Der Lee, MD
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, Beitou District, 112
Taipei Veterans General Hospital
Muh-Hwa Yang, MD
- Not yet recruiting
Mackay Memorial Hospital Taipei
Taipei, Zhongshan District, 104
Mackay Memorial
Nai-Wen Su, MD
- Not yet recruiting
Chang Gung Medical Foundation Linkou
Taoyuan City, Guishan District, 3333
Chang Gung Medical Foundation
Wen-Cheng Chang, MD
United States4 sites, 4 recruiting
- Recruiting
Texas Oncology
Dallas, Texas, 75246
Texas Oncology
Scott Paulson, MD
- Recruiting
SCRI Denver Drug Development Unit
Denver, Colorado, 80218
James Vick
Jason Henry, MD
- Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 37203
Emily Lay Petcu
Meredith Pelster, MD
- Recruiting
University of California San Diego
San Diego, California, 92093
Moores Cancer Center
Sandip Patel, MD
About this study
Official title: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
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).
- Being tested
- Cyclophosphamide, Fludarabine, ACE2016, Pembrolizumab
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Lymphodepleting agent
FludarabineDrug
Lymphodepleting agent
ACE2016Drug
Allogeneic gamma delta T (gdT) cell therapy
PembrolizumabDrug
Immune checkpoint anti-PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| ACE2016 ONLY: 1 DOSE | Experimental | ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE2016 |
| ACE2016 ONLY: 3 DOSES | Experimental | ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE2016 |
| ACE2016 AND PEMBROLIZUMAB: 3 DOSES | Experimental | ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE2016; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort
Measured: 1 year
Change from baseline in clinical laboratory tests results
Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)
Measured: 1 year
Change from baseline in vital signs results
Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)
Measured: 1 year
Recommended Dose (RD)
Measured: 1 year
Secondary outcomes (6)
Persistence of ACE2016 before and after administration
Half-life of ACE2016
Measured: 1 year
Measure of anti-ACE2016 antibodies after administration
Titration of anti-ACE2016 antibodies after administration
Measured: 1 year
Objective Response Rate (ORR)
Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1
Measured: 1 year
Disease Control Rate (DCR)
Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1
Measured: 1 year
Duration Of Response (DOR)
Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death.
Measured: 1 year
Progression Free Survival (PFS)
Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start22 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion27 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acepodia Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415487
- Sponsor's protocol ID
- ACE2016-001
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
- ClinicalTrials.gov ID
- NCT06415487
- Acronym / sponsor ID
- ACE2016-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Acepodia Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 27 Mar 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACE2016 ONLY: 1 DOSE | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: ACE2016ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016. |
| ACE2016 ONLY: 3 DOSES | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: ACE2016ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016. |
| ACE2016 AND PEMBROLIZUMAB: 3 DOSES | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: ACE2016, Drug: PembrolizumabACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)
- At least one measurable lesion as defined by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate hematologic and renal, hepatic and cardiac function
- Oxygen saturation via pulse oximeter ≥92% at rest on room air
Key exclusion criteria (10 listed)
- Prior treatment with a genetically modified cell therapy product targeting EGFR
- History of allogeneic transplantation
- Subjects with active CNS metastases
- History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)
- Clinically significant active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideLymphodepleting agent | Drug | ACE2016 AND PEMBROLIZUMAB: 3 DOSES, ACE2016 ONLY: 1 DOSE, ACE2016 ONLY: 3 DOSES |
| FludarabineLymphodepleting agent | Drug | ACE2016 AND PEMBROLIZUMAB: 3 DOSES, ACE2016 ONLY: 1 DOSE, ACE2016 ONLY: 3 DOSES |
| ACE2016Allogeneic gamma delta T (gdT) cell therapy | Drug | ACE2016 AND PEMBROLIZUMAB: 3 DOSES, ACE2016 ONLY: 1 DOSE, ACE2016 ONLY: 3 DOSES |
| PembrolizumabImmune checkpoint anti-PD-1 antibody | Drug | ACE2016 AND PEMBROLIZUMAB: 3 DOSES |
Primary outcome
Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort
Time frame: 1 year
Change from baseline in clinical laboratory tests results
Time frame: 1 year
Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)
Change from baseline in vital signs results
Time frame: 1 year
Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)
Recommended Dose (RD)
Time frame: 1 year
6 secondary outcomes
Persistence of ACE2016 before and after administration
Time frame: 1 year
Measure of anti-ACE2016 antibodies after administration
Time frame: 1 year
Objective Response Rate (ORR)
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
Duration Of Response (DOR)
Time frame: 1 year
Progression Free Survival (PFS)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Fludarabine and ACE2016 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Acepodia Biotech, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Chien (+1 415 366 7822, clinical@acepodiabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.