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Alkylating Agents

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

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

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

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

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

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

ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously

ACE1702

Janet Pan, MPH

Michael Kurman, MD

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.

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

Tumor response via radiographic assessments

Tumor response via tumor marker assessments (in applicable tumor types)

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).

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.

Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors	NCT04319757	Locally Advance... Metastatic Canc... Solid Tumor HER2-positive G... HER2-positive M...	ACE1702 Cyclophosphamid... Fludarabine	18 Years -	Acepodia Biotech, Inc.
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors	NCT04319757	Locally Advance... Metastatic Canc... Solid Tumor HER2-positive G... HER2-positive M...	ACE1702 Cyclophosphamid... Fludarabine	18 Years -	Acepodia Biotech, Inc.

Spots Global Cancer Trial Database for ace1702

Every month we try and update this database with for ace1702 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ace1702

Every month we try and update this database with for ace1702 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ace1702 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.