Clinical Trials /

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

NCT03593226

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: AGI-134.FIM.101
  • NCT ID: NCT03593226

Conditions

  • Superficial, Palpable, Unresectable/Metastatic Solid Tumour

Interventions

DrugSynonymsArms
AGI-134AGI-134

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
AGI-134ExperimentalAGI-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.
  • AGI-134

Eligibility Criteria

        Inclusion Criteria

          1. Adult male or female aged 18 years old or older.

          2. 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.

          3. Subjects should have at least two measurable lesions based on RECIST v1.1 as
             determined by the site study team.

          4. 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.

          5. With sufficient tumour size for IT injection

          6. 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

          7. Evaluable Disease according to RECIST v1.1

          8. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

          9. 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
             contraception

         12. Subject is able and willing to comply with the requirements of the protocol.

         13. Subject is able to voluntarily provide written informed consent.

        Exclusion Criteria:

          1. Has a disease that is suitable for therapy administered with curative intent.

          2. Has any active, acute, or chronic infection(s) that are uncontrolled and/or requiring
             treatment, such as antibiotics

          3. An active autoimmune disease that has required systemic treatment in the 2 years
             preceding the study

          4. History of or plan for splenectomy or splenic irradiation

          5. History of organ transplant or currently taking active immunosuppressive therapy

          6. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

          7. Has known active or chronic Hepatitis B or Hepatitis C

          8. History or evidence of cancer associated with immunodeficiency states

          9. 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.

         21. 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.

         22. Has a known current additional malignancy that is progressing or requires active
             treatment

         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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Percentage of participants who experience a dose-limiting toxicity (DLT) . DLTs will be assessed during the first cycle (21 days)

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Plasma Drug Concentration of AGI-134, when administered as monotherapy
Measure: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
Safety Issue:
Description: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
Measure: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
Safety Issue:
Description:Assessment of the disease biomarkers that may serve as surrogates or predictors of AGI-134 clinical efficacy

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Agalimmune Ltd.

Last Updated

November 21, 2019