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

NCT05307874 | Completed Phase 1 DMC

• 1 other identifier: ICT01-102
• Study Type: interventional
• Target: 56
• Locations: 3 countries
• Sites: 5

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 of ICT01 +LDSC IL-2, which will be supported by statistical power calculations once the indications are selected. The final regimen will be ICT01 + LDSC IL-2 + Pembrolizumab on a Q3W cycle. The primary objective of Part 2 is to demonstrate the efficacy of the combination regimen based on RECIST1.1 in one or more solid tumor indications.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Treatment-Emergent Adverse Events

  Incidence and severity of adverse events related to study treatment

  1 year

Secondary Outcomes (2)

• Change from baseline in the number of circulating g9d2 T cells

  Cycle Days 8 & 15 for the first 3 cycles

• Disease Control Rate

  1 year

Study Arms (11)

Dose level 2 ICT01 + Low dose SC IL-2

EXPERIMENTAL

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; Drug: Proleukin Injectable Product

Dose Level 1 ICT01 + High dose SC IL-2

EXPERIMENTAL

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; Drug: Proleukin Injectable Product

Dose level 1 ICT01 + Low dose SC IL-2

EXPERIMENTAL

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; Drug: Proleukin Injectable Product

Dose level 3 ICT01 + Low dose SC IL-2

EXPERIMENTAL

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; Drug: Proleukin Injectable Product

Dose level 4 ICT01 + Low dose SC IL-2

EXPERIMENTAL

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; Drug: Proleukin Injectable Product

Dose level 5 ICT01 + Low dose SC IL-2

EXPERIMENTAL

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; Drug: Proleukin Injectable Product

Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 2 ICT01

EXPERIMENTAL

ICT01 IV is given on Day 1 of every 21-day cycle and on day 8 of Cycles 1-3. SC IL-2 is administered on Days 1-5 of Cycles 1/2/3 only.

Drug: ICT01; Drug: Proleukin Injectable Product

Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 3 ICT01

EXPERIMENTAL

ICT01 IV is given on Day 1 of every 21-day cycle and on day 8 of Cycles 1-3. SC IL-2 is administered on Days 1-5 of Cycles 1/2/3 only.

Drug: ICT01; Drug: Proleukin Injectable Product

Dose level 2 ICT01 + Low dose SC IL-2 + Pembrolizumab

EXPERIMENTAL

ICT01 IV and Pembrolizumab are given on Day 1 of every 21-day cycle. SC IL-2 is administred Days 1-5 of cycles 1/2/3 only.

Drug: ICT01; Drug: Proleukin Injectable Product; Drug: Pembrolizumab injection

Dose level 4 ICT01 + Low dose SC IL-2 + Pembrolizumab

EXPERIMENTAL

ICT01 IV and Pembrolizumab are given on Day 1 of every 21-day cycle. SC IL-2 is administred Days 1-5 of cycles 1/2/3 only.

Drug: ICT01; Drug: Proleukin Injectable Product; Drug: Pembrolizumab injection

Primer Dose level 2 ICT01+ Low dose SC IL-2 + Pembrolizumab + Booster Dose level 2 ICT01

EXPERIMENTAL

ICT01 IV and Pembrolizumab are given on Day 1 of every 21-day cycle. ICT01 IV is given on day 8 of Cycles 1-3. SC IL-2 is administered on Days 1-5 of Cycles 1/2/3 only.

Drug: ICT01; Drug: Proleukin Injectable Product; Drug: Pembrolizumab injection

Interventions

ICT01 DRUG

anti-BTN3A mAb IV Q3W

Dose Level 1 ICT01 + High dose SC IL-2; Dose level 1 ICT01 + Low dose SC IL-2; Dose level 2 ICT01 + Low dose SC IL-2; Dose level 2 ICT01 + Low dose SC IL-2 + Pembrolizumab; Dose level 3 ICT01 + Low dose SC IL-2; Dose level 4 ICT01 + Low dose SC IL-2; Dose level 4 ICT01 + Low dose SC IL-2 + Pembrolizumab; Dose level 5 ICT01 + Low dose SC IL-2; Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 2 ICT01; Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 3 ICT01; Primer Dose level 2 ICT01+ Low dose SC IL-2 + Pembrolizumab + Booster Dose level 2 ICT01

Proleukin Injectable Product DRUG

1 MIU/m2 SC IL-2 daily x 5 days for the first 3 cycles

Also known as: IL-2

Dose Level 1 ICT01 + High dose SC IL-2; Dose level 1 ICT01 + Low dose SC IL-2; Dose level 2 ICT01 + Low dose SC IL-2; Dose level 2 ICT01 + Low dose SC IL-2 + Pembrolizumab; Dose level 3 ICT01 + Low dose SC IL-2; Dose level 4 ICT01 + Low dose SC IL-2; Dose level 4 ICT01 + Low dose SC IL-2 + Pembrolizumab; Dose level 5 ICT01 + Low dose SC IL-2; Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 2 ICT01; Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 3 ICT01; Primer Dose level 2 ICT01+ Low dose SC IL-2 + Pembrolizumab + Booster Dose level 2 ICT01

Pembrolizumab injection DRUG

200mg administered following ICT01 + LDSC IL-2 over 30 min Q3W

Dose level 2 ICT01 + Low dose SC IL-2 + Pembrolizumab; Dose level 4 ICT01 + Low dose SC IL-2 + Pembrolizumab; Primer Dose level 2 ICT01+ Low dose SC IL-2 + Pembrolizumab + Booster Dose level 2 ICT01

Eligibility Criteria

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

You may qualify if:

• 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:
• metastatic colorectal cancer (CRC):
• metastatic ovarian cancer:
• metastatic castration-resistant prostate cancer (mCRPC)
• metastatic pancreatic ductal adenocarcinoma (PDAC)
• metastatic or unresectable refractory melanoma
• \) Availability of baseline tumor biopsy and willingness to undergo 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

You may not qualify if:

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

Sponsors & Collaborators

• ImCheck Therapeutics: lead
• ILife Consulting: collaborator
• Exystat: collaborator

Study Sites (5)

Institute Gustave Roussy

Paris, France

Location

IUCT Oncopole Claudius Regaud

Toulouse, France

Location

University Carl Gustav Carus

Dresden, Germany

Location

Universitätsklinikum Wuerzburg

Würzburg, Germany

Location

The Institute of Cancer Research

Sutton, United Kingdom

Location

Related Publications (1)

• De Gassart A, Le KS, Brune P, Agaugue S, Sims J, Goubard A, Castellano R, Joalland N, Scotet E, Collette Y, Valentin E, Ghigo C, Pasero C, Colazet M, Guillen J, Cano CE, Marabelle A, De Bonno J, Hoet R, Truneh A, Olive D, Frohna P. Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vgamma9Vdelta2 T cell-mediated antitumor immune response. Sci Transl Med. 2021 Oct 20;13(616):eabj0835. doi: 10.1126/scitranslmed.abj0835. Epub 2021 Oct 20.

  PMID: 34669444 BACKGROUND

MeSH Terms

Interventions

Interleukin-2; pembrolizumab

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Katrien Lemmens, MD, PhD

  ImCheck Therapeutics

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: May 4, 2022
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

DE (2); GB (1); FR (2)