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

Solid Tumor, Adult Clinical Trial

— EVICTION-2  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307874
• Other study ID #: ICT01-102
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: ImCheck Therapeutics
• Contact: Paul Frohna, MD, PhD
• Phone: +33698465644
• Email: paul.frohna[@]imcheck.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?9d2 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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• ICT01
anti-BTN3A mAb IV Q3W
• Proleukin Injectable Product
1 MIU/m2 SC IL-2 daily x 5 days for the first 3 cycles
• Pembrolizumab injection
200mg administered following ICT01 + LDSC IL-2 over 30 min Q3W

Locations

Country	Name	City	State
France	Institute Gustave Roussy	Paris

Sponsors (3)

Lead Sponsor	Collaborator
ImCheck Therapeutics	Exystat, ILife Consulting

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Emergent Adverse Events	Incidence and severity of adverse events related to study treatment	1 year
Secondary	Change from baseline in the number of circulating g9d2 T cells	flow cytometry measurement of circulating and intratumoral g9d2 T cells	Cycle Days 8 & 15 for the first 3 cycles
Secondary	Disease Control Rate	Stable disease or better by RECIST1.1	1 year