Intratumoral injection of IP-001 after thermal ablation in patients with advanced solid tumors. A multicenter Phase Ib/IIa study in patients with colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma.
Descrizione riassuntiva dello studio
This study investigates the safety and initial efficacy of an immunostimulatory thermal ablation combined with the investigational product IP-001, which is injected into the tumor after ablation (intratumoral). Thermal ablation is a commonly used method for treating various types of cancer. During thermal ablation, high temperatures (thermal) are used to destroy cancer cells. The thermal ablation used in this study is called radiofrequency ablation, where the tumor tissue is heated and destroyed by high-frequency electric current. The investigational product IP-001 is made from the sugar galactose and chitosan (a degradation product of chitin from shellfish, crabs, and crustaceans) and is intended to stimulate the immune system after thermal ablation. All patients in this study receive the combination of thermal ablation and subsequent intratumoral injection of IP-001. The thermal ablation is intended not only to destroy the tumor but also to release substances from the tumor (so-called antigens) that make the tumor more recognizable to the body's immune defense system. The intratumoral injection of IP-001 administered directly into the previously treated tumor after thermal ablation is also intended to further activate the immune system. Previous studies have shown that the combination of the investigational product and thermal ablation may help the immune system (the body's defense system) to act against cancer and destroy the remaining cancer cells in the body. The main objective of this study is to verify how safe the investigational product is and how well the body tolerates it after thermal ablation. Additional objectives also include obtaining preliminary results on the efficacy of the treatment.
(BASEC)
Intervento studiato
This study consists of 3 parts (pre-investigation, treatment, and follow-up) and may last up to one year per patient. During the study, patients receive a thermal ablation lasting up to 30 minutes followed by an intratumoral injection of the investigational product IP-001 into the previously "ablated" tumor tissue. IP-001 is administered at a dosage of 4 ml per thermal ablation. The thermal ablation followed by the IP-001 injection is administered in so-called 'cycles', with one cycle lasting six weeks and the total therapy comprising a maximum of four cycles. The study treatment is always performed on day 1 of a cycle. The treatment is conducted on an outpatient basis. In addition to the study treatment, several examinations are conducted before, during, and after the treatment. The treatment part of the study can last up to 6 months. After the treatment part, there is a follow-up part (up to 5 visits, every 6 weeks) with follow-up examinations. This part lasts approximately 6 months. Additionally, the study includes 4 mandatory scientific research projects where blood samples and biopsies are taken at different times.
(BASEC)
Malattie studiate
Advanced solid tumor of colorectal cancer ("bowel cancer"), non-small cell lung cancer, and soft tissue sarcoma.
(BASEC)
The study is aimed at patients - with a recurrent colorectal cancer (colorectal cancer, CRC; a specific form of bowel cancer), non-small cell lung cancer (non-small cell lung cancer, NSCLC) or soft tissue sarcoma (soft tissue sarcoma, STS), who have previously been treated with chemotherapy and possibly also immunotherapy, - who are in sufficiently good general condition - who have satisfactory blood values including adequate kidney and liver function. (BASEC)
Criteri di esclusione
Patients cannot participate if they - have received a medication-based cancer treatment within the last 3 weeks. - have severe comorbidities (e.g., heart or infectious diseases) including severe autoimmune diseases - have allergies to shellfish, crabs, or crustaceans and to IP-001. (BASEC)
Luogo dello studio
Bellinzona, Berna, Chur, San Gallo
(BASEC)
Sponsor
Immunophotonics Inc., USA Swiss Group for Clinical Cancer Research (SAKK), Bern
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
J. Decoudre
+41 31 389 91 91
trials@cluttersakk.chSwiss Group for Clinical Cancer Research (SAKK)
(BASEC)
Informazioni generali
Cantonal Hospital of St. Gallen,Immunophotonics, Inc.
(ICTRP)
Informazioni scientifiche
Cantonal Hospital of St. Gallen,Immunophotonics, Inc.
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
29.09.2022
(BASEC)
ID di studio ICTRP
NCT05688280 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
IP-IIO-622 SAKK 69/22 Intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors. A multicenter Phase 1b/2a trial in colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients. (BASEC)
Titolo accademico
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase 1b/2a Trial in Colorectal Cancer, Non-small Cell Lung Cancer, and Soft Tissue Sarcoma Patients (ICTRP)
Titolo pubblico
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS (ICTRP)
Malattie studiate
Metastatic Solid Tumor;Colon Cancer;Nonsmall Cell Lung Cancer;Soft Tissue Sarcoma (ICTRP)
Intervento studiato
Drug: 1.0% IP-001 for Injection (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
1. Stage 3 or Stage 4 CRC, NSCLC, or STS who have failed, are ineligible, refused, or
become intolerant to at least first line (but no more than 4 lines) of systemic
therapy
2. Life expectancy of > 6 months. Only have lesions with the longest diameter of = 5
cm.
3. Presence of at least one non-bone tumor lesion that is ablation-accessible, with a
minimum size of 1.0 cm.
4. Measurable disease according to RECIST 1.1.
5. Age = 18 years.
6. ECOG performance status 0-1.
7. Bone marrow function: neutrophil count = 1.5 ? 109/L, platelet count = 100 ? 109/L,
hemoglobin = 90 g/L.
8. Adequate hematological function defined by white blood cell count = 2.5 ? 109/L with
absolute neutrophil count = 1.5 ? 109/L, and hemoglobin = 9 g/dL (transfusions
allowed on study).
9. Adequate hepatic function defined by a total bilirubin level = 1.5 ? the upper limit
of normal (ULN) range and aspartate transaminase (AST) and alanine aminotransferase
(ALT) levels = 2.5 ? ULN for all patients, or for patients with documented
metastatic disease to the liver and AST and ALT levels = 5 ? ULN. Patients with
documented Gilbert disease are allowed if total bilirubin is less than 3 ? ULN.
10. Adequate renal function defined by an estimated creatinine clearance = 50 mL/min
according to the Cockcroft-Gault formula (or local institutional standard method).
11. Men and women with childbearing potential agree to use effective contraception.
Women of childbearing potential must have a negative pregnancy test (serum) before
inclusion.
Exclusion Criteria:
1. Known allergic reaction to shellfish, crabs, crustaceans, or any trial components,
used in trial treatment.
2. Malignant primary brain tumors or evidence of brain metastases or leptomeningeal
disease.
3. Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent
or recent treatment with any other investigational agents within 21 days prior to
treatment.
4. Patients who have not recovered to common terminology criteria for adverse events
(CTCAE) Grade = 1 from all side effects of prior therapies except for residual
toxicities.
5. Patients with a history of malignancy, with the exception of non-melanoma skin
cancers and in situ cancers.
6. Concomitant treatment with systemic corticosteroids (10 mg prednisolone or
equivalent) or other immunosuppressive therapy.
7. Anti-coagulation therapies which cannot be stopped 24 hours prior to trial
treatment.
8. Severe or uncontrolled cardiovascular disease (congestive heart failure New York
Heart Association classification III or IV).
9. Documented HIV positive.
10. Active Hepatitis C or Hepatitis B Viral infection. (ICTRP)
non disponibile
Endpoint primari e secondari
Safety and Tolerability (ICTRP)
Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC);Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC);Efficacy: Objective response according to iRECIST (iOR);Efficacy: Duration of response according to iRECIST (iDOR);Efficacy: Progression-free survival according to iRECIST (iPFS);Efficacy: Objective response according to RECIST 1.1 (OR);Efficacy: Duration of response according to RECIST 1.1 (DOR);Efficacy: Progression-free survival according to RECIST 1.1 (PFS);Efficacy: Time to response according to iRECIST 1.1 (iTTR);Efficacy: Time to response according to RECIST 1.1 (TTR);Efficacy: Disease-free survival (DFS);Efficacy: Overall survival (OS);Efficacy: OR of the injected lesions according to RECIST 1.1;Efficacy: OR of the non-injected lesions according to RECIST 1.1;Efficacy: iOR of the injected lesions according to iRECIST;Efficacy: iOR of the non-injected lesions according to iRECIST (ICTRP)
Data di registrazione
22.12.2022 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Markus Jorger, MD;Diane Beatty, PhD, Cantonal Hospital of St. Gallen,Immunophotonics, Inc. (ICTRP)
ID secondari
IP-IIO-622 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05688280 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile