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Experimental antibody combo shows promise against tough cancers

NCT ID NCT05307874

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

Anyone

Healthy volunteers

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

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

  • Institute Gustave Roussy

    Paris, France

  • The Institute of Cancer Research

    Sutton, United Kingdom

  • University Carl Gustav Carus

    Dresden, Germany

  • Universitätsklinikum Wuerzburg

    Würzburg, Germany

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