Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors (NCT05307874) | Clinical Trial Compass
TerminatedPhase 1/2
Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors
Stopped: The study was terminated based on sponsor decision unrelated to safety or efficacy. The study met the key primary and secondary endpoints, however two patients were receiving treatment at the decision point, preventing protocol-defined completion.
France, Germany, United Kingdom56 participantsStarted 2022-05-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated early — can you find out why it was stopped, and what that means for the safety or effectiveness of ICT01 combined with low-dose IL-2 as a potential treatment approach for me?
2Since this was a Phase 1/2a study primarily measuring treatment-emergent adverse events, what kinds of side effects were being tracked, and do you know what safety signals, if any, emerged before the trial ended?
3Given that this trial is no longer enrolling and has been terminated, are there other active clinical trials studying similar immunotherapy combinations — like gamma-delta T-cell activators or low-dose IL-2 — that might be worth exploring for my type of solid tumor?
4Because this was an early-phase trial focused on safety rather than proven effectiveness, how would you weigh the experimental nature of this approach against established standard-of-care treatments available to me right now?
5Is there any published or preliminary data from this trial that you could review with me, so we can understand whether the scientific rationale behind ICT01 and IL-2 together is still considered promising despite the termination?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.