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Metastatic Colorectal CancerPhase 1/2TASKINNCT05201352

Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1α True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine

A Phase 1/2 study testing trifluridine/tipiracil + XB2001 in people with Metastatic Colorectal Cancer, run by Centre Georges Francois Leclerc at 14 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
trifluridine/tipiracil + XB2001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
14 sitesFrance
Study dates
13 Oct 2022to 13 Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female that must have signed a written informed consent prior to any study specific procedures
  • Aged ≥ 18 years at randomization
  • Patient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1/PDL1 therapy) n.b:
  • a patient treated with oxaliplatin in a neoadjuvant/adjuvant situation with a recurrence of the disease within 6 months following the last administration is considered resistant to oxaliplatin and validates the criterion if no administration of oxaliplatin has been carried out in a metastatic disease situation.
  • exception for VEGF if medically contraindicated during previous metastatic disease treatment (should be clearly documented in the disease history of the patient) it is allowed to included the patient with or without Bevacizumab.
  • Have a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG)
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  • Knowledge of RAS, BRAF, Microsatellite status
  • Baseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria.
  • Patient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance.
  • Adequat hepatic, renal and bone marrow function within the following limits:
  • Total bilirubin ≤ 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome);
  • ASAT et ALAT ≤ 5 times ULN;
  • Measured Creatinine clearance (Cockcroft and Gault) > 30 ml / min
  • Absolute Neutrophil Count (ANC) > 1,5. 109 / L;
  • Platelet count ≥ 150. 109 / L;
  • Haemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused)
  • Albuminemia ≥ 30 g / L;
  • Negative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis
  • Urea protein, urine dipstick should be less than 2 crossese and/or 24 hour proteinuria ≤ 1g/24h
  • Availability of tumor material dated less than 5 years with sufficient quantity (15 to 20 whithe slides) and quality (Good morphological conservation / Presence of tumor tissue / Histopathology consistent with the indication / More than 100 tumor cells)
  • Patient must be affiliated to a social health insurance
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion).
  • Women of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment.
  • Male patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment.
  • Normal ECG or ECG without clinically significant findings with QTcF < 470 ms.

Who cannot join

  • Other concurrent malignancies the last 3 years, except adequately treated cone-biopsied in situ carcinoma (as per exemple of the cervix, basal cell, squamous cell carcinoma of the skin, low risk prostate cancer or other insitu carcinoma juged eligible according the coordinator). Patient who have had potentially curative therapy for a prior malignancy are eligible provided there has been no evidence of disease for ≥ 3 years and the risk of recurrence is considered low.
  • Symptomatic brain metastases
  • Estimated prognosis <3 months.
  • Mutational status BRAF mutant (V600E only)
  • Participation in progress, or in the 30 days preceding the first scheduled day of dosing in this study, in another therapeutic trial with an experimental molecule or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer.
  • Severe unbalanced illness, underlying infection that may prevent the patient from receiving treatment. Patients with a clinically important and unresolved Grade 3 or 4 non-haematologic adverse reaction related to previous therapies. Also participant with any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
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  • Bowel obstruction or sub-obstruction or a history of inflammatory bowel disease or significant gasto intestinal disorder
  • History of autoimmune or inflammatory disease or interstitial lung disease.
  • Patient with congenital galactosemia, total lactase deficiency (lactose intolerance) or glucose-galactose malabsorption syndrome
  • Severe arterial thromboembolic events less than 6 months before randomization
  • New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure (defined as ≥ 160/100 mm Hg)
  • Clinically significant decrease in performance status (medical records) within 2 weeks of intended first dose administration.
  • -Contraindication to receive a treatment with trifluridine/tipiracil or an anti-IL-1α (XB2001 True Human antibody) and/or patient already treated by trifluridine/tipiracil, or an anti-IL-1α.
  • Concomitant systemic treatment with immunotherapy, immunosuppressants, corticosteroid therapy ≥ 10 mg equivalent prednisone/prednisolone or hormone therapy: corticosteroid therapy administered chronically, immunosuppressive treatment, biotherapy administered as part of the management of an inflammatory disease (anti-TNF, anti-IL6, anti-IL1, anti PD-1, anti EGFR etc.) and live virus vaccines administered up to 14 days prior the first scheduled dose of treatement administration.
  • Current pregnancy (mandatory pregnancy test at baseline for female of childbearing potential) or breastfeeding.
  • Patient with any psychiatric, psychological, sociological, geographical problem or other severe concomitant disease, disorder or condition that potentially compromising the understanding of the information, the safety of the patient, the interpretation of study results or the conduct of the study compliance with the study protocol and follow-up schedule.
  • Patient deprived of their liberty or under guardianship, curatorship or safeguard of justice.
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever.
  • Major surgery within 2 weeks prior to randomization or have an unhealed operation wounds.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • ICO Angers

    Angers, 49055

  • Institut Sainte Catherine

    Avignon, 84000

  • CHU Jean Minjoz

    Besançon, 25000

  • Institut Bergonié

    Bordeaux, 33000

  • Centre Hospitalier Carcassonne

    Carcassonne, 11810

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Centre Georges-François Leclerc

    Dijon, Bourgogne-Franche-Comté, 21000

  • CHU Dijon

    Dijon, Bourgogne-Franche-Comté, 21000

  • Hopital Franco-Britannique

    Levallois-Perret, 92300

  • CHU Dupuytren

    Limoges, 87000

  • CHU Nantes

    Nantes, 44000

  • Cario-Hpca

    Plérin, 22190

  • Institut Jean Godinot

    Reims, 51100

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

Other trials in France

About this study

Official title: Multicentric Randomized Phase I/II Study to Evaluate Efficacy of Trifluridine/Tipiracil Plus XB2001 (Anti-IL-1α True Human Antibody) Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine

Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments.

Based on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.

Read the detailed description

This project proposes to evaluate trifluridine/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor.

The project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms:

  • Experimental arm: trifluridine/tipiracil + XB2001
  • Control arm: trifluridine/tipiracil + placebo
Being tested
trifluridine/tipiracil + XB2001, trifluridine/tipiracil + placebo
Keywords
trifluridine/tipiracil, anti-IL-1α True Human antibody, phase I/II
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trifluridine/tipiracil + XB2001Drug

    trifluridine/tipiracil every 28 days + XB2001 1000mg intravenous infusion every 2 weeks

  • trifluridine/tipiracil + placeboDrug

    trifluridine/tipiracil every 28 days + Placebo intravenous infusion every 2 weeks

Study groups in NCT05201352
Study groupRoleWhat they receive
Experimental armExperimentaltrifluridine/tipiracil + XB2001
Receives: Drug: trifluridine/tipiracil + XB2001
Control armPlacebo comparatortrifluridine/tipiracil + placebo
Receives: Drug: trifluridine/tipiracil + placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of XB2001

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Overall survival

    Measured: 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start13 Oct 2022
  3. Primary completion13 Oct 2026 (estimated)
  4. Study completion13 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201352
Sponsor's protocol ID
2020-004601-31
Acronym
TASKIN
Status last verified
May 2025
First submitted
28 Dec 2021
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thibaudin M, Roussot N, Burlot C, Schmitt A, Vincent J, Tharin Z, Bengrine L, Bellio H, Bertaut A, Hampe L, Daumoine S, Rederstorff E, Peroz M, Huppe T, Derangere V, Rageot D, Simard J, Truntzer C, Fumet JD, Ghiringhelli F. Safety and efficacy of trifluridine/tipiracil +/- bevacizumab plus XB2001 (anti-IL-1alpha antibody): a single-center phase 1 trial. Signal Transduct Target Ther. 2025 Jan 17;10(1):22. doi: 10.1038/s41392-024-02116-4.

    PubMed 39820336

  • Fumet JD, Roussot N, Bertaut A, Limagne E, Thibaudin M, Hervieu A, Zanetta S, Borg C, Senellart H, Pernot S, Thuillier F, Carnot A, Mineur L, Chibaudel B, Touchefeu Y, Martin-Babau J, Jary M, Labourey JL, Rederstorff E, Lepage C, Ghiringhelli F. Phase I/II study of trifluridine/tipiracil plus XB2001 versus trifluridine/tipiracil in metastatic colorectal cancer. Future Oncol. 2024;20(38):3077-3085. doi: 10.1080/14796694.2024.2415280. Epub 2024 Nov 12.

    PubMed 39530624

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing trifluridine/tipiracil + XB2001 in people with Metastatic Colorectal Cancer, run by Centre Georges Francois Leclerc at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of XB2001 (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201352, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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