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Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors (EVICTION-2)

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ClinicalTrials.gov Identifier: NCT05307874
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : October 7, 2022
Sponsor:
Collaborators:
ILife Consulting
Exystat
Information provided by (Responsible Party):
ImCheck Therapeutics

Study Description
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Brief Summary:

This is a phase I/IIa, two-part, open-label study to characterize the safety, tolerability, pharmacodynamics, and antitumor activity of ICT01 in combination with LDSC IL-2 in patients with advanced-stage solid tumors.

Part 1 will be a dose escalation of IV ICT01 administered on the first day of every 21-day cycle (CnD1) to patients with advanced-stage solid tumors in combination with LDSC IL-2 (Proleukin®) administered daily on days 1-5 of cycles 1-3 (C1-3D1-5). Objectives of part 1 are to characterize the safety of the combination regimen and determine the RP2D for Part 2.

Part 2 will comprise a maximum of 2 indications and 2 combination dosing regimens, which will be supported by statistical power calculations once the indications are selected. The start of Part 2 will require an amendment to confirm the indication(s) and dosing regimen(s), which will be based on the review of Part 1 data and recommendations by the SRC. The primary objective of Part 2 is to demonstrate the efficacy of the combination regimen based on RECIST1.1.


Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: ICT01 Drug: Proleukin Injectable Product Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-part, Open-label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 in Combination With Low-dose Subcutaneous Interleukin-2 in Patients With Advanced Solid Tumors (EVICTION-2)
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Level 1 ICT01 + Low dose SC IL-2
c
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2
Experimental: Dose level 2 ICT01 + Low dose SC IL-2
For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2
Experimental: Dose Level 1 ICT01 + High dose SC IL-2
For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2
Experimental: Dose level 2 ICT01 + High dose SC IL-2
For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2
Experimental: Dose level 3 ICT01 + Low dose SC IL-2
For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2
Experimental: Dose level 3 ICT01 + High dose SC IL-2
For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2
Experimental: Dose level 4 ICT01 + Low dose SC IL-2
For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2
Experimental: Dose level 4 ICT01 + High dose SC IL-2
For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.
 Drug: ICT01
anti-BTN3A mAb

Drug: Proleukin Injectable Product
Low dose SC IL-2
Other Name: IL-2


Outcome Measures
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Primary Outcome Measures :
  1. Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
    Incidence and severity of adverse events related to study treatment


Secondary Outcome Measures :
  1. Change from baseline in the number of circulating g9d2 T cells [ Time Frame: Cycle Days 8 & 15 for the first 3 cycles ]
    flow cytometry measurement of circulating and intratumoral g9d2 T cells

  2. Disease Control Rate [ Time Frame: 1 year ]
    Stable disease or better by RECIST1.1


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed/refractory patients who have failed at least 2 lines of systemic therapy or who failed first line therapy and are intolerant of or have a contraindication to the standard second line of therapy with histologically or cytologically confirmed diagnosis of:

    1. metastatic colorectal cancer (CRC):
    2. metastatic ovarian cancer:
    3. metastatic castration-resistant prostate cancer (mCRPC)

    4. metastatic pancreatic ductal adenocarcinoma (PDAC)

      2) Willingness to undergo baseline and on-study tumor biopsies 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 RECIST1.1

      Exclusion Criteria:

      1. 1) Any malignancy of γ9δ2 T cell origin
      2. Any systemic anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment
      3. Treatment with investigational drugs 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 ongoing
      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) ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
      7. Ongoing systemic autoimmune disease requiring systemic immunosuppressive therapy
      8. Primary or secondary immune deficiency
      9. Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
      10. Patients with contraindication to IL-2 treatment according to the SmPC/package insert
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05307874


Contacts
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Contact: Paul Frohna, MD, PhD +33698465644 paul.frohna@imcheck.fr

Locations
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France
Institute Gustave Roussy Recruiting
Paris, France
Contact: Stephane Champiat, MD, PhD         
Sponsors and Collaborators
ImCheck Therapeutics
ILife Consulting
Exystat
Investigators
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Study Director: Paul FROHNA, MD, PhD ImCheck Therapeutics
More Information
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Publications:

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Responsible Party: ImCheck Therapeutics
ClinicalTrials.gov Identifier: NCT05307874    
Other Study ID Numbers: ICT01-102
First Posted: April 1, 2022    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents