Informations générales (source: ClinicalTrials.gov)
A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer (EVICTION)
Interventional
Phase 1/Phase 2
ImCheck Therapeutics (Voir sur ClinicalTrials)
février 2020
décembre 2025
23 juillet 2024
Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting
BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by
a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be
a cohort expansion into 2 solid tumor indications and one hematologic malignancy for
ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus
pembrolizumab.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:42 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Aur�lien MARABELLE | 27/05/2024 14:02:23 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Paoli-Calmettes - Marseille - France | Julie Karsenty | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Voluntarily signed informed consent form.
2. Relapsed/refractory patients with histologically or cytologically confirmed
diagnosis of advanced-stage or recurrent cancer, including:
Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group
B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic
leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma,
cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the
approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with
baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate
cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group F: newly diagnosed AML
starting venetoclax/azacitidine Part 2, Group G: checkpoint-refractory metastatic
melanoma with g9d2 T cells >5K Part 2, Group H: chemotx-refractory or Pt-ineligible
urotherlial cancer (bladder) with g9d2 T cells >5K Part 2, Group I:
checkpoint-refractory, metastatic HNSCC with g9d2 T cells >5K
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
4. Life expectancy > 3 months as assessed by the Investigator
5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors
(RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
1. Voluntarily signed informed consent form.
2. Relapsed/refractory patients with histologically or cytologically confirmed
diagnosis of advanced-stage or recurrent cancer, including:
Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group
B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic
leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma,
cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the
approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with
baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate
cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group F: newly diagnosed AML
starting venetoclax/azacitidine Part 2, Group G: checkpoint-refractory metastatic
melanoma with g9d2 T cells >5K Part 2, Group H: chemotx-refractory or Pt-ineligible
urotherlial cancer (bladder) with g9d2 T cells >5K Part 2, Group I:
checkpoint-refractory, metastatic HNSCC with g9d2 T cells >5K
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
4. Life expectancy > 3 months as assessed by the Investigator
5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors
(RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
1. Any malignancy of Vγ9Vδ2 T cell origin
2. Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination
half-life (whichever is shorter) before study treatment (does not apply to patients
receiving ICI for the combination arm)
3. Treatment with investigational drug(s) within 28 days before study treatment
4. Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone
or equivalent, for the last 28 days and need for ongoing treatment.
5. Patients with rapidly progressing disease defined as advanced/metastatic,
symptomatic, visceral spread, with a risk of life-threatening complications in the
short term (e.g., during Screening Period/ treatment washout) that includes patients
with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary
lymphangitis, and over 50% liver involvement
6. Ongoing immune-related adverse events (irAEs) and/or AEs ≥grade 2 not resolved from
previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and
stable endocrinopathies with replacement hormone therapy.
7. Within 4 weeks of major surgery
8. Documented history of active autoimmune disorders requiring systemic
immunosuppressive therapy within the last 12 months
9. Primary or secondary immune deficiency
10. Active and uncontrolled infections requiring intravenous antibiotic or antiviral
treatment