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

Phase 1

Completed

• Conditions: Superficial, Palpable, Unresectable/Metastatic Solid Tumour
• Interventions: Drug: AGI-134

• Registration Number: NCT03593226
• Lead Sponsor: Agalimmune Ltd.

Brief Summary

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

Detailed Description

Study AGI-134.FIM.101 was a Phase I/IIa, first in man (FIM), multi-center, single-arm, open-label study, designed to evaluate the safety and tolerability of escalating doses of AGI-134 as a monotherapy in unresectable/metastatic solid tumors.

The study comprised of 2 parts:

Part 1 was an accelerated escalation of the AGI-134 dose, designed to assess the safety and tolerability of AGI-134, as well as to determine the MTD (maximum tolerated dose) and recommended dose for Part 2 of the study (RP2D).

Part 2 was designed to assess the safety, tolerability and biological activity of AGI-134 at the RP2D in subjects with either deep or superficial unresectable/metastatic solid tumors.

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-20
• Study Start: 2018-11-30
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Results First Submitted: 2024-12-31
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Results First Posted: 2025-02-14
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

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 Adverse Event (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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGI-134 100 mg	AGI-134	100 mg AGI-134 (4 mL) via intratumor 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 50 mg	AGI-134	50 mg AGI-134 (2 mL) via intratumor 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-134 200 mg	AGI-134	200 mg AGI-134 (8 mL) via intratumor 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 25 mg	AGI-134	25 mg AGI-134 (1 mL) via intratumor 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.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of AGI-134 Injected Intra-tumourally (IT)	Up to 3 weeks after first administration of each dose level	Safety and tolerability of AGI-134 injected intra-tumourally (IT) by assessment of the percentage of participants who experienced a dose-limiting toxicity (DLT) . DLTs will be assessed during the first cycle (21 days)
Discontinue Study Drug Due to an Adverse Events	Approximately 12 months	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

Trial Locations

Locations (14)

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

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

University Collage London; 🇬🇧 London, United Kingdom

The Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, United Kingdom

Churchill Hospital; 🇬🇧 Oxford, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Rambam Health Care Campus; 🇮🇱 Haifa, Israel