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JOURNAL ONKOLOGIE – STUDIE

EVICTION First-in-Human Study of ICT01 in Patients With Advanced Cancer

Rekrutierend

NCT-Nummer:
NCT04243499

Studienbeginn:
Februar 2020

Letztes Update:
25.11.2020

Wirkstoff:
IV ICT01

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
ImCheck Therapeutics

Collaborator:
-

Studienleiter

Paul Frohna, MD, PhD
Study Director
ImCheck Therapeutics

Kontakt

Studienlocations (3 von 4)

Alle anzeigen

Studien-Informationen

Brief Summary:

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 an approved checkpoint inhibitor (CPI). Part 2 will

be a cohort expansion into two solid tumor indications and one hematologic malignancy for

ICT01 monotherapy, and one CPI-approved indication receiving ICT01 plus CPI.

Ein-/Ausschlusskriterien

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)

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

Exclusion Criteria:

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

Studien-Rationale

Primary outcome:

1. Adverse Events (Parts 1 & 2) (Time Frame - 6 months):
Incidence of treatment-emergent adverse events

2. Objective Response Rate using RECIST for solid tumor patients (Part 2) (Time Frame - 6 months):
RECIST is measured every 8 weeks during treatment

3. Objective Response Rate using RECIL for lymphoma patients (Part 2) (Time Frame - 6 months):
RECIL is measured every 8 weeks during treatment

Secondary outcome:

1. Change from Baseline in the Number of Circulating Gamma Delta T Cells (Time Frame - 28 days):
Flow cytometric counting of circulating gamma delta T cells

2. Change from Baseline in the Activation State of Circulating Gamma Delta T Cells (Time Frame - 28 days):
Flow cytometric measurement of CD69 and Ki67 expression on gamma delta T cells

3. Cmax following the first dose of ICT01 (Time Frame - 1 day):
PK parameter from serum ICT01 levels

4. AUC following the first dose of ICT01 (Time Frame - 21 days):
PK parameter from serum ICT01 levels

5. Clearance at steady-state of ICT01 (Time Frame - 6 months):
PK parameter from serum ICT01 levels

6. Half-life of ICT01 (Time Frame - 6 months):
PK parameter from serum ICT01 levels

7. Objective Response Rate using iRECIST for solid tumor patients (Part 2) (Time Frame - 6 months):
iRECIST is measured every 8 weeks during treatment

Studien-Arme

  • Experimental: IV ICT01 Monotherapy
    Up to six ICT01 dose levels administered as IV monotherapy every 3 weeks will be tested in Part 1 Dose Escalation and up to 2 dose levels in Part 2 Cohort Expansion
  • Experimental: IV ICT01 + Checkpoint Inhibitor
    A range of IV ICT01 doses administered every 3 weeks will be tested in combination with an approved dosing regimen of CPI in Part 1 Dose Escalation and up to 2 dose levels in Part 2 Cohort Expansion

Geprüfte Regime

  • IV ICT01:
    humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody

Quelle: ClinicalTrials.gov


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