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

Solid Tumor, Adult Clinical Trial

— EVICTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04243499
• Other study ID #: ICT01-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 10, 2020
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: ImCheck Therapeutics
• Contact: Paul Frohna, MD, PhD
• Phone: 8582055285
• Email: paul.frohna[@]imcheck.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

1. Any malignancy of V?9Vd2 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

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer
• Solid Tumor, Adult

Intervention

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
France	Institut Paoli-Calmettes	Marseille
France	Gustave Roussy	Paris
Germany	University Carl Gustav Carus Clinical Trial Unit	Dresden
Spain	Vall d'Hebron Instiute of Oncology	Barcelona
United Kingdom	Institute of Cancer Research	London
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Yale Cancer Center	New Haven	Connecticut
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ImCheck Therapeutics

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (Parts 1 & 2)	Incidence of treatment-emergent adverse events	12 months
Primary	Disease Control Rate using RECIST for solid tumor patients (Part 2)	RECIST is measured every 8 weeks during treatment	12 months
Primary	Disease Control Rate using RECIL for lymphoma patients (Part 2)	RECIL is measured every 8 weeks during treatment	12 months
Secondary	Change from Baseline in the Number of Circulating Gamma Delta T Cells	Flow cytometric counting of circulating gamma delta T cells	28 days
Secondary	Change from Baseline in the Activation State of Circulating Gamma Delta T Cells	Flow cytometric measurement of CD69 and Ki67 expression on gamma delta T cells	28 days
Secondary	Cmax following the first dose of ICT01	PK parameter from serum ICT01 levels	1 day
Secondary	AUC following the first dose of ICT01	PK parameter from serum ICT01 levels	21 days
Secondary	Clearance at steady-state of ICT01	PK parameter from serum ICT01 levels	6 months
Secondary	Half-life of ICT01	PK parameter from serum ICT01 levels	6 months
Secondary	Objective Response Rate using RECIST for solid tumor patients (Part 2)	RECIST is measured every 8 weeks during treatment	12 months