Locally Advanced Solid TumorPhase 1NCT04319757
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
A Phase 1 study testing ACE1702, Cyclophosphamide and Fludarabine in people with Locally Advanced Solid Tumor and Metastatic Cancer, run by Acepodia Biotech, Inc. at 3 sites in 2 countries.
Trial summary
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor
- What is being tested?
- ACE1702, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Jun 2020to 15 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed informed consent
- Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site)
- Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit.
- Histologically confirmed HER2 expression.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Measurable or non-measurable evaluable disease according to RECIST 1.1
- Adequate hematologic and end-organ function at baseline
- Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air
Who cannot join
- Untreated central nervous system (CNS) metastases
- Multiple primary malignancies
- Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
- Pregnant or lactating female
- Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment
- History of autoimmune or immune mediated symptomatic disease
- Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Northwestern Univeristy
Chicago, Illinois, 60611
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.
- Conditions
- Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer
- Being tested
- ACE1702, Cyclophosphamide, Fludarabine
- Keywords
- NK Cell Therapy, Cellular Therapy, Breast Cancer, Gastric Cancer, Ovarian Cancer, Endometrial Cancer, Metastatic Cancer, Colorectal Cancer, Head and Neck Cancer, Pancreatic Cancer, Bladder Cancer, Non-small-cell Lung Carcinoma
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE1702Drug
ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
CyclophosphamideDrug
Lympho-conditioning agent
FludarabineDrug
Lympho-conditioning agent
| Study group | Role | What they receive |
|---|---|---|
| ACE1702 Dose Level 1 | Experimental | Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 immunohistochemistry (IHC) 2+ or above.
Dose Level: 1 Planned number of subjects: 1 to 6 Receives: Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine |
| ACE1702 Dose Level 2 | Experimental | Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.
Dose Level: 2 Planned number of subjects: 1 to 6 Receives: Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine |
| ACE1702 Dose Level 3 | Experimental | Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.
Dose Level: 3 Planned number of subjects: 3 to 6 Receives: Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine |
| ACE1702 Dose Level 4 | Experimental | Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.
Dose Level: 4 Planned number of subjects: 3 to 6 Receives: Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine |
| ACE1702 Dose Level 5 | Experimental | Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.
Dose Level: 5 Planned number of subjects: 3 to 6 Receives: Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine |
| ACE1702 Dose 6 | Experimental | Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.
Dose Level: 6 Planned number of subjects: 3 to 6 Receives: Drug: ACE1702; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)
Number of subjects experiencing adverse events, and the frequency and severity of adverse events.
Endpoint for determining the Maximum Tolerated Dose (MTD). If MTD is not identified, the highest dose administered becomes the Maximum Administered Dose (MAD).
Measured: Day 7 through Day 28 / Day 4 through Day 25
Phase Ib/II starting dose for ACE1702
The recommended phase Ib/II starting dose based on MTD. If MTD is not reached, then the recommended phase Ib/II dose will be determined based on the MAD, safety data, and pharmacodynamics data.
Measured: Through study completion, up to 1 year
Secondary outcomes (2)
Quantify NK cell persistence after administering ACE1702
Duration of ACE1702 persistence
Measured: Day 21
Evaluate immune function after administering ACE1702
Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start24 Jun 2020
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acepodia Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kurman, MD, Study director, Acepodia Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319757
- Sponsor's protocol ID
- ACE1702-001
- Status last verified
- Dec 2024
- First submitted
- 18 Mar 2020
- Last updated
- 5 Dec 2024
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
- ClinicalTrials.gov ID
- NCT04319757
- Acronym / sponsor ID
- ACE1702-001
- Conditions
- Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer
- Keywords
- NK Cell Therapy, Cellular Therapy, Breast Cancer, Gastric Cancer, Ovarian Cancer, Endometrial Cancer, Metastatic Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Acepodia Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 24 Mar 2020 (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.
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ACE1702 Dose Level 1 | Experimental | Drug: ACE1702, Drug: Cyclophosphamide, Drug: FludarabineLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 immunohistochemistry (IHC) 2+ or above. Dose Level: 1 Planned number of subjects: 1 to 6 |
| ACE1702 Dose Level 2 | Experimental | Drug: ACE1702, Drug: Cyclophosphamide, Drug: FludarabineLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 2 Planned number of subjects: 1 to 6 |
| ACE1702 Dose Level 3 | Experimental | Drug: ACE1702, Drug: Cyclophosphamide, Drug: FludarabineLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 3 Planned number of subjects: 3 to 6 |
| ACE1702 Dose Level 4 | Experimental | Drug: ACE1702, Drug: Cyclophosphamide, Drug: FludarabineLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 4 Planned number of subjects: 3 to 6 |
| ACE1702 Dose Level 5 | Experimental | Drug: ACE1702, Drug: Cyclophosphamide, Drug: FludarabineLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 5 Planned number of subjects: 3 to 6 |
| ACE1702 Dose 6 | Experimental | Drug: ACE1702, Drug: Cyclophosphamide, Drug: FludarabineLympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 6 Planned number of subjects: 3 to 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site)
- Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit.
- Histologically confirmed HER2 expression.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Key exclusion criteria (7 listed)
- Untreated central nervous system (CNS) metastases
- Multiple primary malignancies
- Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
- Pregnant or lactating female
- Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment
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 |
|---|---|---|
| ACE1702ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously | Drug | ACE1702 Dose 6, ACE1702 Dose Level 1, ACE1702 Dose Level 2, ACE1702 Dose Level 3, ACE1702 Dose Level 4, ACE1702 Dose Level 5 |
| CyclophosphamideLympho-conditioning agent | Drug | ACE1702 Dose 6, ACE1702 Dose Level 1, ACE1702 Dose Level 2, ACE1702 Dose Level 3, ACE1702 Dose Level 4, ACE1702 Dose Level 5 |
| FludarabineLympho-conditioning agent | Drug | ACE1702 Dose 6, ACE1702 Dose Level 1, ACE1702 Dose Level 2, ACE1702 Dose Level 3, ACE1702 Dose Level 4, ACE1702 Dose Level 5 |
Primary outcome
Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)
Time frame: Day 7 through Day 28 / Day 4 through Day 25
Number of subjects experiencing adverse events, and the frequency and severity of adverse events. Endpoint for determining the Maximum Tolerated Dose (MTD). If MTD is not identified, the highest dose administered becomes the Maximum Administered Dose (MAD).
Phase Ib/II starting dose for ACE1702
Time frame: Through study completion, up to 1 year
The recommended phase Ib/II starting dose based on MTD. If MTD is not reached, then the recommended phase Ib/II dose will be determined based on the MAD, safety data, and pharmacodynamics data.
2 secondary outcomes
Quantify NK cell persistence after administering ACE1702
Time frame: Day 21
Evaluate immune function after administering ACE1702
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- 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. This study is not recruiting at the moment.
Michael Kurman, MD study director
Acepodia Biotech, Inc.
3 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 ACE1702, Cyclophosphamide and Fludarabine in people with Locally Advanced Solid Tumor and Metastatic Cancer, run by Acepodia Biotech, Inc. at 3 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs) (time frame: Day 7 through Day 28 / Day 4 through Day 25). The study lists 2 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 5 Dec 2024.