Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour

Completed · Phase 1/Phase 2

Conditions studied: Superficial, Palpable, Unresectable/Metastatic Solid Tumour

In brief

This study will evaluate if AGI-134 given alone is safe and tolerate in treating patients with unresectable/metastatic solid tumours.

Key facts

Study ID: NCT03593226
Run by: Agalimmune Ltd.
People needed: 38
Starts: 2018-11-30
Expected to finish: 2023-12-31
Last updated by the study team: 2025-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 Adverse Event (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.

Where it is running

UCLA — Los Angeles, California, United States
AHS Hospital Corp. — Morristown, New Jersey, United States
Providence Cancer Institute Franz Clinic — Portland, Oregon, United States
Emek Medical Center — Afula, Israel
Rambam Health Care Campus — Haifa, Israel
Hadassah Hebrew University Medical Center — Jerusalem, Israel
Sheba Medical Center — Ramat Gan, Israel
Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
University of Birmingham — Birmingham, United Kingdom
Edinburgh Cancer Research Centre — Edinburgh, United Kingdom
The Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom
University Collage London — London, United Kingdom
The Christie NHS Foundation Trust — Manchester, United Kingdom
Churchill Hospital — Oxford, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.