Solid TumorPhase 1NCT06258330
Study of AM003 in Patients With Locally Advanced and Metastatic Solid Tumors
A Phase 1 study testing AM003 in people with Solid Tumor, run by Aummune Ltd. at 5 sites in Israel.
Trial summary
This is a phase 1, first-in-human study to assess the safety and tolerability of AM003 in patients with locally advanced and metastatic solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- AM003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesIsrael
- Study dates
- 22 Jun 2022to 1 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age ≥18 years at the time of signing the informed consent.
- Capable of providing signed informed consent, which includes compliance with the requirements of this protocol.
- Participants with histologically confirmed locally advanced/metastatic solid tumors who received and progressed after or were intolerant to at least 1 prior systemic therapy (unless no Standard of Care therapy exists) and are not candidates for any therapy known to confer clinical benefit.
- Eligible for recruitment are participants with a variety of solid tumors such as:
- Head and neck cancers
- Thyroid cancers
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- Soft tissue sarcoma
- Colorectal cancers
- Skin (melanoma and non-melanoma),
- other cancer indications may be considered, but require sponsor approval NOTE: prior exposure to PD-1 or PDL-1 inhibitors are permitted.
- Lesions that are amenable to IT injection (by visual inspection, palpation, ultrasound or CT guidance). At least one measurable lesion must be amenable to both IT injection and biopsy. A measurable distant, discrete lesion that is also amenable to biopsy is optional.
- All participants must have measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam, in at least one dimension (longest diameter to be recorded).
- 5.1. For cohort 1 (dose level 1) participant must have at least one lesion ≥ 1.5 cm 5.2. For cohorts 2 and 3 (dose levels 2\&3), participant should preferably have at least one lesion ≥ 2.5cm and ≥ 5cm for cohorts 2 and 3 respectively. For cases in which no such single lesion can be identified, the total dose of AM003 may be split among several lesions or between a lesion and local SC administration(s).
- Personalized AM003 sequence identified for the participant during the pre-screening period or previous related studies.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.
- Life expectancy of >3 months.
- Have adequate organ function as defined by the following laboratory values within 7 days of dosing the first dose of AM003:
- System Lab Value Hematology Absolute neutrophil count ≥ 1,000/μl Platelets ≥ 100,000/ul Hemoglobin ≥ 9 g/dL Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Partial Thromboplastin Time (PTT) or Activated Partial Thromboplastin Time(aPTT) <1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Renal Serum creatinine ≤ 1.5 x ULN or creatinine clearance (observed or estimated using the Cockcroft-Gault equation) ≥ 45 mL/min Hepatic Total bilirubin ≤ 1.5 x ULN (except participants with Gilbert syndrome who must have a total bilirubin level of < 3.0 x ULN) AST/ALT ≤ 3.0 x upper limits of normal (ULN) or ≤ 5.0 x ULN in participants with hepatocellular carcinoma or if liver metastases are present
- Male and female participants of child-bearing potential must agree to use highly effective contraception while enrolled in the study and receiving the experimental drug, and for at least 3 months after the last treatment. Female participants of child-bearing potential must have a negative serum pregnancy test confirmed within 7 days of receiving the initial dose of AM003 therapy.
Who cannot join
- Clinical evidence of active central nervous system (CNS) disease NOTE: Participants are eligible if brain metastases are adequately treated and participants are neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment) for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of≤ 10 mg daily prednisone (or equivalent)
- History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment.
- Participants with congestive heart failure (≥NYHA class 3) or unstable angina pectoris.
- Active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses < 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Prior severe hypersensitivity reaction to treatment with a monoclonal antibody
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- Has not fully recovered from any effects of major surgery, and be free of significant detectable infection. Surgeries that required general anesthesia must be completed at least 2 weeks before first study drug administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study drug administration and participants should be recovered.
- History of organ transplant.
- Positive antibody and antigen tests for hepatitis virus B (HBV), hepatitis virus C (HCV) and human immunodeficiency virus (HIV). In the case of positive antibodies and a negative antigen test for hepatitis virus B or negative PCR for hepatitis virus C (representing convalescence) inclusion is permitted.
- Any Serious illness, uncontrolled inter-current illness, psychiatric illness, active of uncontrolled infection or other medical history, including laboratory results, which, in the opinion of the Investigator, would preclude the participant from adhering to the protocol or would increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results.
- Participant received other investigational therapy, definitive radiation within 2 weeks, immunotherapy or treatment with anticancer medications within 28 days or at least 5 half-lives prior to the first dose of treatment, whichever is less.
- Participant is currently not recovered to baseline or CTCAE Grade 1 from the AEs due to cancer therapeutics administered more than 28 days prior to the first dose of treatment except for alopecia and peripheral neuropathy
- Pregnant or breastfeeding women.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Rambam Health Care Campus
Haifa
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva, 49100
Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: A Phase I, Open-Label Multicenter Study of AM003 Dose Escalation, Administered Intratumorally to Patients With Locally Advanced and Metastatic Solid Tumors
This is a phase 1, first-in-human study to assess the safety and tolerability of AM003 in patients with locally advanced and metastatic solid tumors
Read the detailed description
This is a phase 1, open-label , multicenter dose escalation trial evaluating the safety and tolerability of AM003 , administered intratumorally to patients with locally advanced and metastatic solid tumors
- Conditions
- Solid Tumor
- Being tested
- AM003
- Keywords
- Phase 1, Dose escalation, Personalized treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM003Drug
Bispecific Personalized Aptamer for intratumoral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - low dose | Experimental | AM003 34 mg Receives: Drug: AM003 |
| Cohort 2 - mid dose | Experimental | AM003 68 mg Receives: Drug: AM003 |
| Cohort 3 - high dose | Experimental | AM003 136 mg Receives: Drug: AM003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SAEs, TEAEs assessed by CTCAE v.5.0
Measured: First 28 days of treatment
Number of TEAEs meeting protocol defined DLT criteria
Number and percent of participants experiencing dose-limiting toxicities (DLTs), Grade 3 non-hematological adverse AEs, Grade 4 hematological AEs, and discontinuations of study drug due to AE intolerance.
Measured: First 28 days of treatment
Secondary outcomes (4)
Number of participants responding to treatment by RESICT 1.1 criteria
Estimating the ORR, Disease Control Rate, CR, PR and SD lasting at least 8 weeks by RECIST 1.1
Measured: Duration of the study, estimated to be 6 months
Number of participants responding to treatment by iRECIST criteria
Estimating the ORR, Disease Control Rate, CR, PR and SD lasting at least 8 weeks by iRECIST.
Measured: Duration of the study, estimated to be 6 months
AM003 PK parameters - Cmax
Maximum concentration (Cmax)
Measured: First 5 weeks of treatment
AM003 PK parameters - AUC
Area under the curve (AUC).
Measured: First 5 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start22 Jun 2022
- Primary completion7 Jul 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aummune Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irit Carmi Levy, PhD, Study chair, GM and Chief Scientific Officer Aummune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258330
- Sponsor's protocol ID
- AM003-FIH-001
- Status last verified
- Jan 2025
- First submitted
- 1 Jun 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Multicenter Study of AM003 Dose Escalation, Administered Intratumorally to Patients With Locally Advanced and Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06258330
- Acronym / sponsor ID
- AM003-FIH-001
- Conditions
- Solid Tumor
- Keywords
- Phase 1, Dose escalation, Personalized treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aummune Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, first-in-human study to assess the safety and tolerability of AM003 in patients with locally advanced and metastatic solid tumors
Detailed description
This is a phase 1, open-label , multicenter dose escalation trial evaluating the safety and tolerability of AM003 , administered intratumorally to patients with locally advanced and metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - low dose | Experimental | Drug: AM003AM003 34 mg |
| Cohort 2 - mid dose | Experimental | Drug: AM003AM003 68 mg |
| Cohort 3 - high dose | Experimental | Drug: AM003AM003 136 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥18 years at the time of signing the informed consent.
- Capable of providing signed informed consent, which includes compliance with the requirements of this protocol.
- Participants with histologically confirmed locally advanced/metastatic solid tumors who received and progressed after or were intolerant to at least 1 prior systemic therapy (unless no Standard of Care therapy exists) and are not candidates for any therapy known to confer clinical benefit.
- Lesions that are amenable to IT injection (by visual inspection, palpation, ultrasound or CT guidance). At least one measurable lesion must be amenable to both IT injection and biopsy. A measurable distant, discrete lesion that is also amenable to biopsy is optional.
- All participants must have measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam, in at least one dimension (longest diameter to be recorded).
Key exclusion criteria (13 listed)
- Clinical evidence of active central nervous system (CNS) disease NOTE: Participants are eligible if brain metastases are adequately treated and participants are neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment) for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of≤ 10 mg daily prednisone (or equivalent)
- History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment.
- Participants with congestive heart failure (≥NYHA class 3) or unstable angina pectoris.
- Active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses < 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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 |
|---|---|---|
| AM003Bispecific Personalized Aptamer for intratumoral administration | Drug | Cohort 1 - low dose, Cohort 2 - mid dose, Cohort 3 - high dose |
Primary outcome
Number of SAEs, TEAEs assessed by CTCAE v.5.0
Time frame: First 28 days of treatment
Number of TEAEs meeting protocol defined DLT criteria
Time frame: First 28 days of treatment
Number and percent of participants experiencing dose-limiting toxicities (DLTs), Grade 3 non-hematological adverse AEs, Grade 4 hematological AEs, and discontinuations of study drug due to AE intolerance.
4 secondary outcomes
Number of participants responding to treatment by RESICT 1.1 criteria
Time frame: Duration of the study, estimated to be 6 months
Number of participants responding to treatment by iRECIST criteria
Time frame: Duration of the study, estimated to be 6 months
AM003 PK parameters - Cmax
Time frame: First 5 weeks of treatment
AM003 PK parameters - AUC
Time frame: First 5 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Irit Carmi Levy, PhD study chair
GM and Chief Scientific Officer Aummune
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AM003 in people with Solid Tumor, run by Aummune Ltd. at 5 sites in Israel.
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 19 inclusion and 13 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of SAEs, TEAEs assessed by CTCAE v.5.0 (time frame: First 28 days of treatment). 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?
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 28 Jan 2025.