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Trial Title:
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
NCT ID:
NCT06341647
Condition:
Breast Cancer
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
- Safety: incidence and severity of AE and SAE [Time Frame: From the time of consent
through End of Study (up to 18 months per patient)]
- Determination of Recommended Phase 2 Dose (RP2D)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AB-201
Description:
NK Cell Therapy
Arm group label:
Phase 1a Dose Escalation
Arm group label:
Phase 1b Dose Expansion
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Lymphodepleting chemotherapy
Arm group label:
Phase 1a Dose Escalation
Arm group label:
Phase 1b Dose Expansion
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Lymphodepleting chemotherapy
Arm group label:
Phase 1a Dose Escalation
Arm group label:
Phase 1b Dose Expansion
Summary:
This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two
phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine
the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors.
Detailed description:
This is a Phase 1, multicenter study designed to evaluate the safety, tolerability, and
efficacy of AB-201 in subjects with advanced HER2+ solid tumors (specifically, breast and
gastric/GEJ cancers).
The Phase 1 will be conducted in two parts, an initial dose escalation stage followed by
a dose expansion stage.
Study participation for each subject begins with up to 28 days (1 month) of screening
following written informed consent, then lymphodepletion treatment, followed by AB-201.
Up to 3 doses of AB-201 may be administered. All subjects will be monitored for a total
duration of 18 months of follow up from the first dose administration of AB-201.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ECOG performance status 0 to 1.
- Histologically confirmed HER2 expressed breast or gastric/GEJ cancer IHC ≥ 2+ within
6 months prior to study entry.
- Confirmed diagnosis of an advanced/unresectable or metastatic HER2+ breast or
gastric/GEJ cancer that is refractory to, or intolerable of standard treatment, or
for which no standard treatment is available.
- Must have received prior cancer therapy: Subjects with breast cancer must have
received ≥ 3 prior systemic therapies; subjects with gastric/GEJ cancer must have
received ≥ 2 prior systemic therapy(ies); subjects with IHC 3+ or IHC 2+/ISH+
cancers must have received previous treatment with a HER2-targeting therapy.
Exclusion Criteria:
- Known past or current malignancy other than inclusion diagnosis.
- Known clinically significant cardiac disease.
- Active central nervous system (CNS) metastases, or involvement of the CNS, unless
there is a history of at least 3 months of sustained remission.
- Unresolved toxicities from prior anticancer therapy.
- Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or
anti-viral therapy.
- History of sensitivity or intolerance to cyclophosphamide or fludarabine.
- Currently Pregnant or lactating
- Severe disease progression or health deterioration within 2 weeks prior to
lymphodepletion regimen.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Contact:
Last name:
Michael Michael
Phone:
+6138559-5000
Email:
Michael.Michael@petermac.org
Facility:
Name:
The Alfred Hosptial
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Contact:
Last name:
Mark Voskoboynik, Dr
Phone:
+613-9076-3129
Email:
m.voskoboynik@alfred.org.au
Facility:
Name:
Austin Hosptial
Address:
City:
Melbourne
Zip:
3084
Country:
Australia
Contact:
Last name:
Hui Gan, Dr
Phone:
+61 3 9496 9925
Email:
Hui.Gan@onjcri.org.au
Start date:
October 31, 2024
Completion date:
February 2029
Lead sponsor:
Agency:
GC Cell Corporation
Agency class:
Industry
Source:
GC Cell Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06341647
