Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06258330
Other study ID # AM003-FIH-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 22, 2022
Est. completion date June 15, 2024

Study information

Verified date February 2024
Source Aummune Ltd.
Contact Irit Carmi Levy, PhD
Phone +972-747402830
Email irit@aummune.tech
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date June 15, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age =18 years at the time of signing the informed consent. 2. Capable of providing signed informed consent, which includes compliance with the requirements of this protocol. 3. 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 - 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. 4. 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. 5. 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). 6. Personalized AM003 sequence identified for the participant during the pre-screening period or previous related studies. 7. Eastern Cooperative Oncology Group (ECOG) performance status score =1. 8. Life expectancy of >3 months. 9. 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 10. 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. Exclusion Criteria: 1. 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) 2. History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment. 3. Participants with congestive heart failure (=NYHA class 3) or unstable angina pectoris. 4. 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. 5. 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. 6. Prior severe hypersensitivity reaction to treatment with a monoclonal antibody 7. 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. 8. History of organ transplant. 9. 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. 10. 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. 11. 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. 12. 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 13. Pregnant or breastfeeding women.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AM003
Bispecific Personalized Aptamer for intratumoral administration

Locations

Country Name City State
Israel Rambam Health Care Campus Haifa
Israel Hadassah Medical Center Jerusalem
Israel Rabin Medical Center Petach Tikva
Israel Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Aummune Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of SAEs, TEAEs assessed by CTCAE v.5.0 First 28 days of treatment
Primary 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. First 28 days of treatment
Secondary 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 Duration of the study, estimated to be 6 months
Secondary 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. Duration of the study, estimated to be 6 months
Secondary AM003 PK parameters - Cmax Maximum concentration (Cmax) First 5 weeks of treatment
Secondary AM003 PK parameters - AUC Area under the curve (AUC). First 5 weeks of treatment
See also
  Status Clinical Trial Phase
Recruiting NCT05580991 - Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors Phase 1
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Active, not recruiting NCT02846038 - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Recruiting NCT05159388 - A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT06014502 - Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors Phase 1
Recruiting NCT04107311 - Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Active, not recruiting NCT04078152 - Durvalumab Long-Term Safety and Efficacy Study Phase 4
Completed NCT02250157 - A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies Phase 1
Recruiting NCT05566574 - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT03943004 - Trial of DFP-14927 in Advanced Solid Tumors Phase 1
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Recruiting NCT05798546 - Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02) Phase 1
Recruiting NCT05525858 - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT00479128 - Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors Phase 1
Recruiting NCT04143789 - Evaluation of AP-002 in Patients With Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2