Superficial, Palpable, Unresectable/Metastatic Solid TumourPhase 1/2NCT03593226

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

A Phase 1/2 study testing AGI-134 in people with Superficial, Palpable, Unresectable/Metastatic Solid Tumour, run by Agalimmune Ltd. at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Superficial, Palpable, Unresectable/Metastatic Solid Tumour
What is being tested?: AGI-134
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 14 sitesin 3 countries
Study dates: 30 Nov 2018to 31 Dec 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 15Show fewer

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.

Who cannot join

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)

Show all 25Show fewer

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.

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

United Kingdom6 sites

University of Birmingham
Birmingham, B15 2TT
Edinburgh Cancer Research Centre
Edinburgh, EH4 2XR
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
University Collage London
London, W1T 7HA
The Christie NHS Foundation Trust
Manchester, M20 4BX
Churchill Hospital
Oxford, OX3 7LE

Other trials in United Kingdom

Israel5 sites

Emek Medical Center
Afula, 7177871
Rambam Health Care Campus
Haifa, 3109601
Hadassah Hebrew University Medical Center
Jerusalem
Sheba Medical Center
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906

Other trials in Israel

United States3 sites

UCLA
Los Angeles, California, 90095
AHS Hospital Corp.
Morristown, New Jersey, 07960
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Superficial, Palpable, Unresectable/Metastatic Solid Tumour
Being tested: AGI-134

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGI-134Drug
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.

Study groups in NCT03593226
Study group	Role	What they receive
AGI-134 25 mg	Experimental	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. Receives: Drug: AGI-134
AGI-134 50 mg	Experimental	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. Receives: Drug: AGI-134
AGI-134 100 mg	Experimental	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. Receives: Drug: AGI-134
AGI-134 200 mg	Experimental	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. Receives: Drug: AGI-134

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of AGI-134 Injected Intra-tumourally (IT)
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)
Measured: Up to 3 weeks after first administration of each dose level
Discontinue Study Drug Due to an Adverse Events
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
Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 201831 Dec 2023

First posted20 Jul 2018
Study start30 Nov 2018
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Superficial, Palpable, Unresectable/Metastatic Solid TumourStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Part 1 (Accelerated escalation): An accelerated escalation dose study designed to assess the safety and tolerability of escalating doses of AGI-134, as well as the Maximum Tolerated Dose (MTD) and the Part 2 dose (RP2D). Part 2: This part of the study was designed to assess the safety, tolerability and anti-tumour activity of AGI-134 as a monotherapy
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03593226
Sponsor's protocol ID: AGI-134.FIM.101
Status last verified: Jan 2025
First submitted: 5 Jun 2018
Last updated: 14 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03593226
Acronym / sponsor ID: AGI-134.FIM.101
Conditions: Superficial, Palpable, Unresectable/Metastatic Solid Tumour
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Agalimmune Ltd.Industry (pharma, biotech, devices)
Study start: 30 Nov 2018 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 20 Jul 2018 (actual)
Results: Posted 14 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The study comprised of 2 parts:

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Part 1 (Accelerated escalation): An accelerated escalation dose study designed to assess the safety and tolerability of escalating doses of AGI-134, as well as the Maximum Tolerated Dose (MTD) and the Part 2 dose (RP2D). Part 2: This part of the study was designed to assess the safety, tolerability and anti-tumour activity of AGI-134 as a monotherapy

Arm	Type	Receives
AGI-134 25 mg	Experimental	Drug: AGI-13425 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.
AGI-134 50 mg	Experimental	Drug: AGI-13450 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-134 100 mg	Experimental	Drug: AGI-134100 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-134 200 mg	Experimental	Drug: AGI-134200 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (25 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AGI-134AGI-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.	Drug	AGI-134 100 mg, AGI-134 200 mg, AGI-134 25 mg, AGI-134 50 mg

Primary outcome

Safety and Tolerability of AGI-134 Injected Intra-tumourally (IT)
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 14 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AGI-134 25 mg	6	0
AGI-134 50 mg	19	0
AGI-134 100 mg	7	0
AGI-134 200 mg	6	0

Primary outcome: Safety and Tolerability of AGI-134 Injected Intra-tumourally (IT)

Time frame: Up to 3 weeks after first administration of each dose level. Count of participants. Unit: Participants

Measure	AGI-134 25 mg n = 6	AGI-134 50 mg n = 19	AGI-134 100 mg n = 7	AGI-134 200 mg n = 6
Value	0	0	0	0

Primary outcome: Discontinue Study Drug Due to an Adverse Events

Time frame: Approximately 12 months. Count of participants. Unit: Participants

Measure	AGI-134 25mg/1mL n = 6	AGI-134 50mg/2mL n = 19	AGI-134 100mg/4mL n = 7	AGI-134 200mg/8mL n = 6
Value	0	1	0	0

Adverse events

Time frame: AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall	18 of 38 (47.4%)	38 of 38 (100%)	1 of 38
AGI-134 25 mg	3 of 6 (50%)	6 of 6 (100%)	0 of 6
AGI-134 50 mg	8 of 19 (42.1%)	19 of 19 (100%)	0 of 19
AGI-134 100 mg	2 of 7 (28.6%)	7 of 7 (100%)	0 of 7
AGI-134 200 mg	5 of 6 (83.3%)	6 of 6 (100%)	1 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AGI-134 in people with Superficial, Palpable, Unresectable/Metastatic Solid Tumour, run by Agalimmune Ltd. at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United Kingdom, Israel, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of AGI-134 Injected Intra-tumourally (IT) (time frame: Up to 3 weeks after first administration of each dose level). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03593226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.