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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE1702 | Drug | ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Through study completion, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify NK cell persistence after administering ACE1702 | Duration of ACE1702 persistence | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1 | Tumor response via radiographic assessments | Day 35 (+7 day window) of each 6 week cycle, up to 24 months |
| Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kurman, MD | Acepodia Biotech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Univeristy | Chicago | Illinois | 60611 | United States | ||
| MD Anderson Cancer Center |
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|
| 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 |
|
| 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 |
|
| Cyclophosphamide | Drug | Lympho-conditioning agent |
|
| Fludarabine | Drug | Lympho-conditioning agent |
|
| Day 21 |
Tumor response via tumor marker assessments (in applicable tumor types) |
| Day 35 (+7 day window) of each 6 week cycle, up to 24 months |
| Houston |
| Texas |
| 77030 |
| United States |
| Taipei Veteran General Hospital | Taipei | Taiwan |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010182 | Pancreatic Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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