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

NCT ID: NCT05307874

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2025-10-09

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

Dose level 1 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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

Dose level 5 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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

Pembrolizumab injection

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

Pembrolizumab injection

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

ICT01

Intervention Type: DRUG

anti-BTN3A mAb IV Q3W

Proleukin Injectable Product

Intervention Type: DRUG

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

Pembrolizumab injection

Intervention Type: DRUG

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

Interventions

ICT01

anti-BTN3A mAb IV Q3W

Intervention Type: DRUG

Proleukin Injectable Product

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

Intervention Type: DRUG

Pembrolizumab injection

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

Intervention Type: DRUG

Other Intervention Names

IL-2

Eligibility 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)

5. metastatic or unresectable refractory melanoma

2) 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ILife Consulting

UNKNOWN

Sponsor Role: collaborator

Exystat

OTHER

Sponsor Role: collaborator

ImCheck Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrien Lemmens, MD, PhD

Role: STUDY_DIRECTOR

ImCheck Therapeutics

Locations

Institute Gustave Roussy

Paris, , France

IUCT Oncopole Claudius Regaud

Toulouse, , France

University Carl Gustav Carus

Dresden, , Germany

Universitätsklinikum Wuerzburg

Würzburg, , Germany

The Institute of Cancer Research

Sutton, , United Kingdom

Countries

France; Germany; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 34669444 (View on PubMed)

Other Identifiers

ICT01-102

Identifier Type: -

Identifier Source: org_study_id