Experimental antibody combo shows promise against tough cancers
NCT ID NCT05307874
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tested a new antibody called ICT01 combined with low-dose interleukin-2 (IL-2) in 56 people with advanced solid tumors like colorectal, ovarian, and pancreatic cancer. The goal was to see if the combo is safe and can shrink tumors. Early results suggest it may help control the disease, but more research is needed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ICT01 (an antibody) combined with low-dose interleukin-2 (IL-2) and optionally pembrolizumab
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is an early-phase trial with only 56 participants, so results may not apply to everyone. Side effects are possible, and the combination may not shrink tumors in most patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
56 people
The number who actually took part.
- Started
-
May 2022
- Finished
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Oct 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
IUCT Oncopole Claudius Regaud
Toulouse, France
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Institute Gustave Roussy
Paris, France
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The Institute of Cancer Research
Sutton, United Kingdom
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University Carl Gustav Carus
Dresden, Germany
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Universitätsklinikum Wuerzburg
Würzburg, Germany
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Other studies related to the condition(s) this trial covers.
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- New drug candidate takes aim at Hard-to-Treat pancreatic cancer
- Mining Responders' tumors for clues to a universal cancer therapy