Can a new antibody outsmart advanced solid tumors?

NCT ID NCT06154291

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing an experimental drug called XON7 in people with advanced or metastatic solid tumors who have no effective standard treatment left. XON7 is a specially engineered antibody designed to attack cancer cells, given through an IV. The study has two parts: first, to find the safest dose and check for side effects, and second, to see how well it shrinks or controls tumors in specific cancer types.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XON7, an experimental glyco-humanized polyclonal antibody given by IV infusion
What this could lead to
If XON7 proves safe and effective, it could offer a new treatment option for people with advanced or metastatic solid tumors who have run out of standard therapies.
What could go wrong
This is an early-stage, first-in-human trial, so safety and effectiveness are not yet established. The drug may cause side effects or fail to shrink tumors, and results may not apply to all cancer types.

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

About 255 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Nov 2027

An estimate. End dates often move.

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. Provide signed, written informed consent. 2. Male and female participant, age ≥ 18 years old (at the time consent is obtained) 3. Solid tumors indications: * Participant in phase I, must have a histologically or cytologically confirmed advanced or metastatic solid tumors for which no effective standard therapy is available. All tumor types except glioblastoma, could be included. * Participant in phase II, must have histologically or cytologically confirmed advanced or metastatic solid tumors of the following: NSCLC, gastro-esophageal adenocarcinoma, CRC, pancreatic cancer, Sarcoma, TNBC, or ovarian cancer. 4. Line of treatment: Participant must have solid tumors progressing after ≤ 4 lines of standard appropriate anticancer therapies for the specific tumor type, or for which the patient is ineligible. Participants whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority-approved appropriate targeted therapy for their tumor types before enrollment. 5. Measurable disease per RECIST version 1.1 - v5 6. (ECOG) performance status (PS) 0-1 7. Life expectancy of at least 12 weeks. 8. Adequate organ function 9. QT duration corrected for heart rate by Fridericia's formula (QTcF) \<450 msec or QTcF \<480 msec for participants with bundle branch block. 10. In France, a participant will be eligible for inclusion in this trial only if either affiliated to or a beneficiary of a social security category. 11. Female participant who are not of child-bearing potential, and female participants of child-bearing potential who have a negative serum pregnancy test within 7 days prior to initial trial treatment. Female participants of child-bearing potential, and all male partners must consent to use a medically acceptable method of contraception throughout the trial period and for at least 60 days after the last dose of XON7. A barrier method of contraception must be included. 12. Male participant willing to use adequate contraceptive measures throughout the trial period and for at least 60 days after the last dose of trial intervention. 13. For phase II, participant in pharmacodynamics cohort must provide biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy between day 36 and 42 after trial intervention administration. 14. For phase II, participant in pharmacodynamics cohort must have accessible tumor tissue available for fresh biopsy except for ovarian cancer and sarcoma. Exclusion Criteria: 1. A participant who has received more than 4 prior lines of therapy for advanced or metastatic disease. 2. A participant who has had a prior anti-cancer mAb within 3 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier prior to trial Day 1. 3. A participant who has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (Except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy). 4. A participant with ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation. 5. A participant whose toxicity related to prior treatment has not resolved to Grade 1 (except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy). 6. A participant who has received major surgery 2 weeks before the first dose of trial treatment or has not recovered adequately from the toxicity and/or complications from any surgery (major or minor) before initiating trial treatment. 7. Concomitant use of another experimental drug, or wash-out period of at least 5 half-lives for a previous experimental drug not completed before start of trial intervention 8. Participant treated with drugs known to prolong the QT interval 9. Participant with carcinomatous meningitis. 10. Central nervous system (CNS) metastases, with the exception of individuals who have been previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids for 3 weeks prior to first dose of trial drug. 11. Malignancies other than disease under trial within 3 years prior to first dose of trial intervention. 12. History of autoimmune disease 13. Active or uncontrolled infections requiring systemic treatment (known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C). 14. Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the trial such as history or evidence of cardiovascular risk including any of the following: * Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third-degree atrioventricular block. * Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment. * Documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system (NYHA, 1994). 15. Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. 16. Current active liver or biliary disease (Except for Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment). 17. Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of trial treatment. 18. Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. 19. Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and/or asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor. 20. History of (non-infectious) pneumonitis that required steroids or current pneumonitis. 21. Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions. 22. Participant who has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony- stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM- CSF\], recombinant erythropoietin) within 2 weeks before the first dose of trial intervention. 23. Known, current drug or alcohol abuse. 24. Female participant who is pregnant or lactating. 25. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 26. Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol. 27. For France, patients under legal protection (safeguard, guardianship, curatorship)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69003, France

  • Hôpital Foch

    RECRUITING

    Suresnes, 92150, France

  • IUCT-Oncopole

    RECRUITING

    Toulouse, 31100, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, 33076, France

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

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