Clinical Trials List
Protocol NumberACE2016-001
Active
2024-12-01 - 2027-12-31
Phase I
Recruiting5
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)
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Sponsor
Acepodia Biotech, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chan-Keng Yang Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
- Ming-Mo Hou Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- ZHENG-WEI ZHOU Division of Hematology & Oncology
- Cheng-Lun Lai Division of Hematology & Oncology
- HSIN-CHEN LIN Division of Hematology & Oncology
- 吳承翰 Division of Hematology & Oncology
- 楊陽生 Division of Hematology & Oncology
- YU-HSUAN SHIH Division of Hematology & Oncology
- Huey-En Tzeng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tien-Hua Chen Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
- 唐振育 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
kang-Yun LEE
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Objectives
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To evaluate the safety and tolerability of ACE2016 in subjects with relapsed locally advanced or metastatic solid tumors expressing EGFR
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To identify the recommended dose of ACE2016 for further investigation in subjects with relapsed advanced solid tumors expressing EGFR
Test Drug
injective
Active Ingredient
ACE2016
Dosage Form
246
Dosage
1.25 x 10^9 cells/ml10mL
Endpoints
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
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Change from baseline in clinical laboratory tests, vital signs, and ECG results
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Recommended Dose (RD)
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Change from baseline in clinical laboratory tests, vital signs, and ECG results
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Recommended Dose (RD)
Inclution Criteria
1.
Signed informed consent
2.
Male or female ≥18 years of age at the time of informed consent
3.
A minimum weight of (60 kg or 132 lbs) is required for doses of ACE2016 of 1,000 x 10⁶ cells
4.
Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy):
•
Subjects with locally advanced disease are eligible if standard therapy that is known to offer clinical benefit is not available, or who are medically ineligible forstandard
therapy due to their underlying condition or concomitant medical conditions, or unwilling receive standard therapy.
•
Subjects with actionable molecular alterations (e.g., EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS) must have progressed on standard directed targeted therapy
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Documented positive EGFR expression as determined by immunohistochemistry report at some point in the patient’s medical history (to be provided at screening to determine subject’s eligibility)
o
Subjects whose tumors are known to express EGFR (e.g., Head and Neck Squamous Cell Carcinoma, Colorectal, and Non-small Cell Lung), but for whom do not have an immunohistochemistry report and/or IHC test results available, may be considered in consultation with the Sponsor’s Medical Monitor
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Subjects who have refused surgery and standard therapy for locally resectable disease and those who are checkpoint inhibitor naïve who have refused standard therapy may be eligible
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Subjects whose tumors are known to be responsive to checkpoint inhibitors should have completed such therapy unless medically ineligible due to underlying conditions or concomitant medical conditions.
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Subjects must have no available standard treatment, are unsuitable for standard treatment, or are unwilling to accept standard treatment.
5.
Patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
6.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
7.
Adequate hematologic function independent of platelet transfusion and growth factor support for at least 14 days prior to the planned start of the lymphodepletion regimen, defined as:
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Platelet count >75,000 cells/mm3 (75 × 109/L)
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Absolute neutrophil count ≥1,500 cells/mm3 (1.5 × 109/L)
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Coagulation parameters must be within institutional normal ranges
Signed informed consent
2.
Male or female ≥18 years of age at the time of informed consent
3.
A minimum weight of (60 kg or 132 lbs) is required for doses of ACE2016 of 1,000 x 10⁶ cells
4.
Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy):
•
Subjects with locally advanced disease are eligible if standard therapy that is known to offer clinical benefit is not available, or who are medically ineligible forstandard
therapy due to their underlying condition or concomitant medical conditions, or unwilling receive standard therapy.
•
Subjects with actionable molecular alterations (e.g., EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS) must have progressed on standard directed targeted therapy
•
Documented positive EGFR expression as determined by immunohistochemistry report at some point in the patient’s medical history (to be provided at screening to determine subject’s eligibility)
o
Subjects whose tumors are known to express EGFR (e.g., Head and Neck Squamous Cell Carcinoma, Colorectal, and Non-small Cell Lung), but for whom do not have an immunohistochemistry report and/or IHC test results available, may be considered in consultation with the Sponsor’s Medical Monitor
•
Subjects who have refused surgery and standard therapy for locally resectable disease and those who are checkpoint inhibitor naïve who have refused standard therapy may be eligible
•
Subjects whose tumors are known to be responsive to checkpoint inhibitors should have completed such therapy unless medically ineligible due to underlying conditions or concomitant medical conditions.
•
Subjects must have no available standard treatment, are unsuitable for standard treatment, or are unwilling to accept standard treatment.
5.
Patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
6.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
7.
Adequate hematologic function independent of platelet transfusion and growth factor support for at least 14 days prior to the planned start of the lymphodepletion regimen, defined as:
•
Platelet count >75,000 cells/mm3 (75 × 109/L)
•
Absolute neutrophil count ≥1,500 cells/mm3 (1.5 × 109/L)
•
Coagulation parameters must be within institutional normal ranges
Exclusion Criteria
1.
Prior treatment with a genetically modified cell therapy product targeting EGFR
2.
History of allogeneic transplantation
3.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products, or subjects who are known to be allergic to cetuximab or the active ingredient or excipients present in KEYTRUDA®.
4.
Subjects with active CNS metastases. Subjects with a prior history of CNS metastases whose metastases have been treated, who are no longer on pharmacologic doses of corticosteroids and who are neurologically stable are eligible. Subjects with meningeal carcinomatosis are not eligible.
5.
History or presence of a clinically relevant CNS disorder such as seizure disorder (e.g., epilepsy), cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome (PRES), or any autoimmune disease with CNS involvement
6.
History of other malignancies, except:
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Malignancy treated with curative intent and with no known active disease present for ≥2 years before the first dose of study drug and felt to be at low risk for recurrence by the treating physician.
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Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
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Adequately treated localized prostate cancer with a current prostate specific antigen (PSA) value of <0.1 ng/mL
Prior treatment with a genetically modified cell therapy product targeting EGFR
2.
History of allogeneic transplantation
3.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products, or subjects who are known to be allergic to cetuximab or the active ingredient or excipients present in KEYTRUDA®.
4.
Subjects with active CNS metastases. Subjects with a prior history of CNS metastases whose metastases have been treated, who are no longer on pharmacologic doses of corticosteroids and who are neurologically stable are eligible. Subjects with meningeal carcinomatosis are not eligible.
5.
History or presence of a clinically relevant CNS disorder such as seizure disorder (e.g., epilepsy), cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome (PRES), or any autoimmune disease with CNS involvement
6.
History of other malignancies, except:
•
Malignancy treated with curative intent and with no known active disease present for ≥2 years before the first dose of study drug and felt to be at low risk for recurrence by the treating physician.
•
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•
Adequately treated localized prostate cancer with a current prostate specific antigen (PSA) value of <0.1 ng/mL
The Estimated Number of Participants
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Taiwan
32 participants
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Global
54 participants
