Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour
This study will evaluate if AGI-134 given alone is safe and tolerate in treating patients with unresectable/metastatic solid tumours.
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
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.
You can join if…
Open to people ages 18 years and up
- 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
10. Adequate organ function 11. Women of childbearing potential and all men must agree to use 2 methods of an adequate
12. Subject is able and willing to comply with the requirements of the protocol. 13. Subject is able to voluntarily provide written informed consent.
You CAN'T join 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.
10. 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
11. Is expected to require any other form of antineoplastic therapy while on study 12. Had received live vaccines within 30 days prior to the first dose of trial treatment. 13. Has positive Immunoglobulin E (IgE) anti -Gal 14. 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
15. Has known allergy or hypersensitivity to any of the test compounds, materials or
contraindication to test product
16. 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)
17. Has received other experimental therapies or used an investigational device within 28
days of the first dose of treatment
18. 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
19. 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.
20. 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.
22. Has a known current additional malignancy that is progressing or requires active
23. O2 saturation < 92% (on room air). 24. 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.
25. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
Los Angeles California 90095 United States
- Providence Cancer Institute Franz Clinic
Portland Oregon 97213 United States
- in progress, not accepting new patients
- Start Date
- Completion Date
- Agalimmune Ltd.
- Phase 1/2 research study
- Study Type
- Expecting 40 study participants
- Last Updated