- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593226
Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour
A Phase I/IIA, Multicentre, Two Parts, Open-Label Study Designed to Evaluate the Safety and Tolerability of Escalating Doses of AGI-134 in Unresectable/Metastatic Solid Tumours
Study Overview
Status
Intervention / Treatment
Detailed Description
Unresectable solid tumour is a tumour that cannot be removed completely through surgery, radiation therapy, drug treatment or any combination of them.
AGI-134 (alpha-Gal) is a synthetic molecule that by intratumoural injection trigger a systemic anti-tumour response.
This study will evaluate the safety, tolerability and efficacy of AGI-134 given alone in treating patients with unresectable metastatic solid tumours.
This study is divided to 2 parts:
Part 1 will assess on a small group of subjects the safety and tolerability of increasing doses of AGI-134 injected intra-tumourally (IT) and will determine the maximum AGI-134 dose that can be tolerated.
Part 2 will assess the safety, tolerability and clinical effect of the dose selected in part 1 in a group of subjects who will receive AGI-134 alone injected intra-tumourally.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Afula, Israel, 7177871
- Emek Medical Center
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Jerusalem, Israel
- Hadassah Hebrew University Medical Center
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Birmingham, United Kingdom, B15 2TT
- University of Birmingham
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Edinburgh, United Kingdom, EH4 2XR
- Edinburgh Cancer Research Centre
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Glasgow, United Kingdom, G12 0YN
- The Beatson West of Scotland Cancer Centre
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London, United Kingdom, W1T 7HA
- University Collage London
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Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
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Oxford, United Kingdom, OX3 7LE
- Churchill Hospital
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California
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Los Angeles, California, United States, 90095
- UCLA
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New Jersey
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Morristown, New Jersey, United States, 07960
- AHS Hospital Corp.
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Oregon
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Portland, Oregon, United States, 97213
- Providence Cancer Institute Franz Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Adult male or female aged 18 years old or older.
- Have a histologically or cytologically confirmed unresectable metastatic solid tumour and who have received or been intolerant to all curative treatment options and treatments demonstrated to prolong survival.
- Subjects should have at least two measurable lesions based on RECIST v1.1 as determined by the site study team.
- Subjects who are willing to undergo tumour biopsies, unless tumour is considered inaccessible or biopsy is otherwise considered not in the subject's best interest.
- With sufficient tumour size for IT injection
Has ≥ 2 lesions:
Has ≥1 injectable lesion which is amenable to injection and biopsy and is measurable according to RECIST v1.1.
Has ≥1 metastatic lesion is amenable for biopsy and measurable according to RECIST v1.1
- Evaluable Disease according to RECIST v1.1
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Has a life expectancy >3 months
- Adequate organ function
- Women of childbearing potential and all men must agree to use 2 methods of an adequate contraception
- Subject is able and willing to comply with the requirements of the protocol.
- Subject is able to voluntarily provide written informed consent.
Exclusion Criteria:
- Has a disease that is suitable for therapy administered with curative intent.
- Has any active, acute, or chronic infection(s) that are uncontrolled and/or requiring treatment, such as antibiotics
- An active autoimmune disease that has required systemic treatment in the 2 years preceding the study
- History of or plan for splenectomy or splenic irradiation
- History of organ transplant or currently taking active immunosuppressive therapy
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has known active or chronic Hepatitis B or Hepatitis C
- History or evidence of cancer associated with immunodeficiency states
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Is expected to require any other form of antineoplastic therapy while on study
- Had received live vaccines within 30 days prior to the first dose of trial treatment.
- Has positive Immunoglobulin E (IgE) anti -Gal
- Subject has a known allergy to alpha-Gal, such as red meat allergy, exposure to lone star tick (Amblyomma americanum), Ixodes ricinus/ holocyclus, or Cetuximab allergy
- Has known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product
- History or evidence of central nervous system metastases and/or carcinomatous meningitis (unless stable without treatment for at least 6 weeks and not requiring steroids)
- Has received other experimental therapies or used an investigational device within 28 days of the first dose of treatment
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to study Day 1 or has not recovered from AE ≤ Grade 1 by treatment administered more than 14 days before first dose
- Has had a prior anti-cancer monoclonal antibody (mAb) within 28 days prior to study Day 1 or who has not recovered from AE ≤ Grade 1 by treatment administered more than 28 days earlier.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has unstable angina, new onset angina within the last 3 months, myocardial infarction within the last 6 months, uncontrolled atrial fibrillation, or current congestive heart failure with New York Heart Association Class III or higher.
- Has a known current additional malignancy that is progressing or requires active treatment
- O2 saturation < 92% (on room air).
- Has an underlying medical condition that would preclude study participation or other psychological, social or physical examination finding or a laboratory abnormality that the Investigator considers would make the subject a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AGI-134
AGI-134 via IT injection.
The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
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AGI-134 via IT injection.
The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of AGI-134 injected intra-tumourally (IT) by assessing the percentage of participants who experience a dose-limiting toxicity (DLT)
Time Frame: Up to 3 weeks at each dose level
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Percentage of participants who experience a dose-limiting toxicity (DLT) .
DLTs will be assessed during the first cycle (21 days)
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Up to 3 weeks at each dose level
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Discontinue Study Drug Due to an Adverse Events
Time Frame: 54 weeks
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Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event (AE) AEs are defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment, is also an AE.
The percentage of participants who discontinue study treatment due to an AE will be presented
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54 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pharmacokinetics profile of AGI-134 (Plasma Drug Concentration of AGI-134)
Time Frame: At the beginning of cycles 1, 2, 3 and 4 (each cycle is 3 weeks long) prior to the drug administration and up to 72 hours post drug administration
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Plasma Drug Concentration of AGI-134, when administered as monotherapy
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At the beginning of cycles 1, 2, 3 and 4 (each cycle is 3 weeks long) prior to the drug administration and up to 72 hours post drug administration
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Change in Immune-Response Following AGI-134 Administration
Time Frame: On Baseline visit, at the end of cycle 3 (which is 3 weeks long) and in week 54
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Assessment of the immune-response to AGI-134 to support the Mechanism of Action (MoA) that may serve as surrogates or predictors of clinical efficacy
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On Baseline visit, at the end of cycle 3 (which is 3 weeks long) and in week 54
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Change in Disease Biomarker Following AGI-134 Administration
Time Frame: On Baseline visit, at the end of cycle 3 (which is 3 weeks long) and in week 54
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Assessment of the disease biomarkers that may serve as surrogates or predictors of AGI-134 clinical efficacy
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On Baseline visit, at the end of cycle 3 (which is 3 weeks long) and in week 54
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGI-134.FIM.101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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