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

NCT04243499 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ICT01-101
• Study Type: interventional
• Target: 292
• Locations: 6 countries
• Sites: 29

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 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.

Conditions

Solid Tumor, Adult; Hematopoietic/Lymphoid Cancer

Keywords

gamma delta T cells; butyrophilin; pembrolizumab

Outcome Measures

Primary Outcomes (3)

• Adverse Events (Parts 1 & 2)

  Incidence of treatment-emergent adverse events

  12 months

• Disease Control Rate using RECIST for solid tumor patients (Part 2)

  RECIST is measured every 8 weeks during treatment

  12 months

• Disease Control Rate using RECIL for lymphoma patients (Part 2)

  RECIL is measured every 8 weeks during treatment

  12 months

Secondary Outcomes (7)

• Change from Baseline in the Number of Circulating Gamma Delta T Cells

  28 days

• Change from Baseline in the Activation State of Circulating Gamma Delta T Cells

  28 days

• Cmax following the first dose of ICT01

  1 day

• AUC following the first dose of ICT01

  21 days

• Clearance at steady-state of ICT01

  6 months

Study Arms (2)

IV ICT01 Monotherapy

EXPERIMENTAL

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

Biological: IV ICT01

IV ICT01 + IV Pembrolizumab

EXPERIMENTAL

A range of IV ICT01 doses administered every 3 weeks will be tested in combination with 200 mg pembrolizumab in Part 1 Dose Escalation and up to 2 dose levels of ICT01 plus 200 mg pembrolizumab in Part 2 Cohort Expansion

Biological: IV ICT01

Interventions

IV ICT01 BIOLOGICAL

humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody

IV ICT01 + IV Pembrolizumab; IV ICT01 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed informed consent form.
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Life expectancy \> 3 months as assessed by the Investigator
• At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or \>5% marrow blasts

You may not qualify if:

• Any malignancy of Vγ9Vδ2 T cell origin
• 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)
• Treatment with investigational drug(s) within 28 days before study treatment
• 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.
• 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
• 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.
• Within 4 weeks of major surgery
• Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
• Primary or secondary immune deficiency
• Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment

Sponsors & Collaborators

• ImCheck Therapeutics: lead

Study Sites (29)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

US Oncology Research

Irving, Texas, 75063, United States

Location

University of Washington

Seattle, Washington, 98133, United States

Location

Institut Jules Bordet

Brussels, Belgium

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Haut Leveque

Bordeaux, 33600, France

Location

Centre Hospitalier Lyon Sud

Lyon, 69310, France

Location

Centre Lyon Berard

Lyon, France

Location

CHU Lyon

Lyon, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

CHU Nantes

Nantes, 44093, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Pitie-Salpetriere

Paris, 75013, France

Location

Institut Curie

Paris, 75248, France

Location

Gustave Roussy

Paris, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

University Carl Gustav Carus Clinical Trial Unit

Dresden, Germany

Location

universitatklinikum Wurburg

Würzburg, Germany

Location

START Barcelone HM Nou Delfos

Barcelona, 08023, Spain

Location

Vall d'Hebron Instiute of Oncology

Barcelona, Spain

Location

START Madrid-FJD, Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Institute of Cancer Research

London, United Kingdom

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Katrien Lemmens, MD, PhD

  ImCheck Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to a dose level of ICT01 at the time of their enrollment

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: March 5, 2020
• Primary Completion: October 15, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12); US (8); DE (2); BE (1); GB (2); ES (4)