Status:
COMPLETED
Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors
Lead Sponsor:
ImCheck Therapeutics
Collaborating Sponsors:
ILife Consulting
Exystat
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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-st...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05307874
Start Date
May 4 2022
End Date
October 9 2025
Last Update
December 24 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute Gustave Roussy
Paris, France
2
IUCT Oncopole Claudius Regaud
Toulouse, France
3
University Carl Gustav Carus
Dresden, Germany
4
Universitätsklinikum Wuerzburg
Würzburg, Germany