AzTrials
AzTrials

Advanced Solid TumorPhase 1/2FIPO23NCT06154291

FIH XON7 in Advanced/Metastatic Solid Tumors

A Phase 1/2 study testing XON7 in people with Advanced Solid Tumor and Metastatic Cancer, run by Xenothera SAS at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Cancer
What is being tested?
XON7
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
5 sitesin 2 countries
Study dates
14 Nov 2023to Nov 2027
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

  • Provide signed, written informed consent.
  • Male and female participant, age ≥ 18 years old (at the time consent is obtained)
  • 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.
  • 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.
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  • Measurable disease per RECIST version 1.1 - v5
  • (ECOG) performance status (PS) 0-1
  • Life expectancy of at least 12 weeks.
  • Adequate organ function
  • QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 msec or QTcF <480 msec for participants with bundle branch block.
  • 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.
  • 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.
  • 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.
  • 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.
  • For phase II, participant in pharmacodynamics cohort must have accessible tumor tissue available for fresh biopsy except for ovarian cancer and sarcoma.

Who cannot join

  • A participant who has received more than 4 prior lines of therapy for advanced or metastatic disease.
  • 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.
  • 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).
  • A participant with ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation.
  • 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).
  • 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.
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  • 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
  • Participant treated with drugs known to prolong the QT interval
  • Participant with carcinomatous meningitis.
  • 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.
  • Malignancies other than disease under trial within 3 years prior to first dose of trial intervention.
  • History of autoimmune disease
  • Active or uncontrolled infections requiring systemic treatment (known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C).
  • 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).
  • Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
  • 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).
  • Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of trial treatment.
  • Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
  • 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.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
  • 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.
  • Known, current drug or alcohol abuse.
  • Female participant who is pregnant or lactating.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.
  • For France, patients under legal protection (safeguard, guardianship, curatorship)

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Françoise SHNEIKER, MD contact

+33652720301

francoise.shneiker@xenothera.com

Alain BALEYDIER contact

+33672800375

alain.baleydier@xenothera.com

5 sites in 2 countries

France4 sites, 4 recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Antoine Italiano, MD, +33 5 56 33 33 85, A.Italiano@bordeaux.unicancer.fr

    Recruiting

  • Centre Léon Bérard

    Lyon, 69003

    Jean-Yves BLAI, MD, jean-yves.blay@lyon.unicancer.fr

    Recruiting

  • Hôpital Foch

    Suresnes, 92150

    Jaafar BENNOUNA, MD, j.bennouna@hopital-foch.com

    Recruiting

  • IUCT-Oncopole

    Toulouse, 31100

    Jean-Pierre DELORD, MD, delord.jean-pierre@iuct-oncopole.fr

    Recruiting

Other trials in France

Belgium1 site, 1 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Ahmad Hussein AWADA, MD, ahmad.awada@bordet.be

    Recruiting

Other trials in Belgium

About this study

Official title: Phase I/II, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors

This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.

Being tested
XON7
Keywords
Advanced or metastatic solid tumors
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • XON7Drug

    The trial intervention (XON7) is a glyco-humanized polyclonal antibody drug which is formulated for intravenous (IV) administration

Study groups in NCT06154291
Study groupRoleWhat they receive
Dose Escalation part then Expansion partExperimentalDose Escalation part: Six dose levels are planned: 1.5; 3; 6; 12; 16 and 20mg/kg Expansion part: Up to 7 cohorts (1 cohort for one selected solid tumor type) could be investigated: Cohort E1: Non-small cell lung cancer (NSCLC) Cohort E2: Gastro-esophageal adenocarcinoma Cohort E3: Colorectal cancer (CRC) Cohort E4: Pancreatic cancer Cohort E5: Sarcoma Cohort E6: Triple-negative breast cancer (TNBC) Cohort E7: Ovarian cancer
Receives: Drug: XON7

What is being measured

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

  1. Dose Escalation part: Dose Limiting Toxicities (DLTs)

    Investigator defined DLT during first treatment cycle

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

  2. Dose Escalation part: treatment emergent adverse events (TEAEs)

    An overall summary of AE occurrences with onset during the first treatment cycle will be presented; this will include the following AE attributes:

    • Preferred term,
    • Maximum CTCAE grade,
    • Outcome,
    • Time to first occurrence [days].

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

  3. Dose Escalation part: clinically significant changes in Leucocytes count

    Incidence and magnitude of clinically significant changes in Leucocytes Count (G/L)

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

  4. Dose Escalation part: clinically significant changes in Red Blood Cells Count

    Incidence and magnitude of clinically significant changes in Red Blood Cells Count (T/L)

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

  5. Dose Escalation part: clinically significant changes in Hemoglobin

    Incidence and magnitude of clinically significant changes in Hemoglobin (g/dL).

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

  6. Dose Escalation part: clinically significant changes in Hematocrit

    Incidence and magnitude of clinically significant changes in Hematocrit (%).

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

  7. Dose Escalation part: clinically significant changes in Absolute Neutrophil Count

    Incidence and magnitude of clinically significant changes in Absolute Neutrophil Count (G/L).

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

  8. Dose Escalation part: clinically significant changes in Absolute Eosinophil Count

    Incidence and magnitude of clinically significant changes in Absolute Eosinophil Count (G/L).

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

  9. Dose Escalation part: clinically significant changes in Absolute Basophil Count

    Incidence and magnitude of clinically significant changes in Absolute Basophil Count (G/L).

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

  10. Dose Escalation part: clinically significant changes in Absolute Lymphocytes Count

    Incidence and magnitude of clinically significant changes in Absolute Lymphocytes Count (G/L).

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

  11. Dose Escalation part: clinically significant changes in Absolute Monocytes Count

    Incidence and magnitude of clinically significant changes in Absolute Monocytes Count (G/L).

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

  12. Dose Escalation part: clinically significant changes in Platelet Count

    Incidence and magnitude of clinically significant changes in Platelet Count (G/L).

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

  13. Dose Escalation part: clinically significant changes in Albumin

    Incidence and magnitude of clinically significant changes in Albumin (g/L).

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

  14. Dose Escalation part: clinically significant changes in Bicarbonate

    Incidence and magnitude of clinically significant changes in Bicarbonate (mmol/L).

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

  15. Dose Escalation part: clinically significant changes in Total Bilirubin

    Incidence and magnitude of clinically significant changes in Total Bilirubin (µmol/L).

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

  16. Dose Escalation part: clinically significant changes in Calcium

    Incidence and magnitude of clinically significant changes in Calcium (mmol/L).

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

  17. Dose Escalation part: clinically significant changes in Urea

    Incidence and magnitude of clinically significant changes in Urea (mmol/L).

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

  18. Dose Escalation part: clinically significant changes in Chloride

    Incidence and magnitude of clinically significant changes in Chloride (mmol/L).

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

  19. Dose Escalation part: clinically significant changes in Creatinine

    Incidence and magnitude of clinically significant changes in Creatinine (µmol/L).

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

  20. Dose Escalation part: clinically significant changes in Creatinine Clearance

    Incidence and magnitude of clinically significant changes in Creatinine Clearance (mL/min).

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

  21. Dose Escalation part: clinically significant changes in Glucose

    Incidence and magnitude of clinically significant changes in Glucose (mmol/L).

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

  22. Dose Escalation part: clinically significant changes in Magnesium

    Incidence and magnitude of clinically significant changes in Magnesium (mmol/L).

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

  23. Dose Escalation part: clinically significant changes in Phosphate

    Incidence and magnitude of clinically significant changes in Phosphate (mmol/L).

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

  24. Dose Escalation part: clinically significant changes in Potassium

    Incidence and magnitude of clinically significant changes in Potassium (mmol/L).

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

  25. Dose Escalation part: clinically significant changes in Sodium

    Incidence and magnitude of clinically significant changes in Sodium (mmol/L).

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

  26. Dose Escalation part: clinically significant changes in Total Protein

    Incidence and magnitude of clinically significant changes in Total Protein (g/L).

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

  27. Dose Escalation part: clinically significant changes in Alanine aminotransferase (ALT)

    Incidence and magnitude of clinically significant changes in Alanine aminotransferase (ALT) (U/L).

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

  28. Dose Escalation part: clinically significant changes in Aspartate aminotransferase (AST)

    Incidence and magnitude of clinically significant changes in Aspartate aminotransferase (AST) (U/L).

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

  29. Dose Escalation part: clinically significant changes in Gamma-glutamyl transférase (GGT)

    Incidence and magnitude of clinically significant changes in Gamma-glutamyl transférase (GGT) (U/L).

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

  30. Dose Escalation part: clinically significant changes in Alkaline Phosphatase (ALP)

    Incidence and magnitude of clinically significant changes in Alkaline Phosphatase (ALP) (U/L).

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

  31. Dose Escalation part: clinically significant changes in Lactate dehydrogenase (LDH)

    Incidence and magnitude of clinically significant changes in Lactate dehydrogenase (LDH) (U/L).

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

  32. Dose Escalation part: clinically significant changes in Amylase

    Incidence and magnitude of clinically significant changes in Amylase (U/L).

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

  33. Dose Escalation part: clinically significant changes in Lipase

    Incidence and magnitude of clinically significant changes in Lipase (U/L).

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

  34. Dose Escalation part: clinically significant changes in Total Protein Creatine Kinase (CK)

    Incidence and magnitude of clinically significant changes in Total Protein Creatine Kinase (CK) (U/L).

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

  35. Dose Escalation part: clinically significant changes in Creatine kinase - cardiac muscle isoenzyme (CK-MB)

    Incidence and magnitude of clinically significant changes in Creatine kinase - cardiac muscle isoenzyme (CK-MB) (U/L).

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

  36. Dose Escalation part: clinically significant changes in Troponin T

    Incidence and magnitude of clinically significant changes in Troponin T (ng/L).

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

  37. Dose Escalation part: clinically significant changes in Prothrombin Time (PT)

    Incidence and magnitude of clinically significant changes in Prothrombin Time (PT) (Sec).

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

  38. Dose Escalation part: clinically significant changes in INR (if under VKA Therapy)

    Incidence and magnitude of clinically significant changes in INR (if under VKA Therapy)

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

  39. Dose Escalation part: clinically significant changes in Activated Partial Thromboplastin Time (aPTT)

    Incidence and magnitude of clinically significant changes in Activated Partial Thromboplastin Time (aPTT) (Sec).

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

  40. Dose Escalation part: clinically significant findings in blood pressure (BP)

    Incidence and severity of clinically significant findings in blood pressure: Significant blood pressure increase will be defined as BP >150/100 mmHg in a subject without a history of hypertension or increased >20 mmHg (diastolic) from baseline measurement in a subject with a previous history of hypertension.

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

  41. Dose Escalation part: clinically significant findings in electrocardiogram (ECGs)

    Incidence of clinically significant findings in Electrocardiogram (ECG): Significant QTc prolongation will be defined as an interval ≥500 msec or an interval which increases by ≥60 msec over baseline

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

  42. Expansion part: Anti-tumors efficacy

    Objective response rate (ORR): defined as the proportion of participants with a confirmed complete response [CR] or confirmed partial response [PR] assessed by investigators according to RECIST v1.1.

    Measured: Within 3 months after XON7 initiation

Secondary outcomes (65)

  1. Pharmacokinetics (PK) of XON7 (Part 1): Cmax

    XON7 peak plasma concentration (Cmax) in plasma

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  2. Pharmacokinetics (PK) of XON7 (Part 2): Cmax

    XON7 peak plasma concentration (Cmax) in plasma

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  3. Pharmacokinetics (PK) of XON7 (Part 1): Tmax

    Time to peak drug concentration in plasma (Tmax)

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  4. Pharmacokinetics (PK) of XON7 (Part 2): Tmax

    Time to peak drug concentration in plasma (Tmax)

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  5. Pharmacokinetics (PK) of XON7 (Part 1): AUC

    Area under the plasma concentration versus time curve (AUC). AUC24hours; AUC0-14days and AUC15-28days will be assessed

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  6. Pharmacokinetics (PK) of XON7 (Part 2): AUC

    Area under the plasma concentration versus time curve (AUC). AUC24hours; AUC0-14days and AUC15-28days will be assessed

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  7. Pharmacokinetics (PK) of XON7 (Part 1): Ctrough

    Trough concentration (Ctrough) is the concentration reached by XON7 immediately before the next dose is administered

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  8. Pharmacokinetics (PK) of XON7 (Part 2): Ctrough

    Trough concentration (Ctrough) is the concentration reached by XON7 immediately before the next dose is administered

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  9. Pharmacokinetics (PK) of XON7 (Part 1): Cmin

    Cmin for the minimum blood plasma concentration reached by XON7 during the time interval between administration of two doses

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  10. Pharmacokinetics (PK) of XON7 (Part 2): Cmin

    Cmin for the minimum blood plasma concentration reached by XON7 during the time interval between administration of two doses

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  11. Pharmacokinetics (PK) of XON7 (Part 1): T1/2

    Half-life (T1/2) refers to the time required for plasma concentration of XON7 to decrease by 50%

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  12. Pharmacokinetics (PK) of XON7 (Part 2): T1/2

    Half-life (T1/2) refers to the time required for plasma concentration of XON7 to decrease by 50%

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  13. Pharmacokinetics (PK) of XON7 (Part 1): CL

    Clearance (CL) is the volume of blood or plasma cleared of XON7 from the body per unit of time

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  14. Pharmacokinetics (PK) of XON7 (Part 2): CL

    Clearance (CL) is the volume of blood or plasma cleared of XON7 from the body per unit of time

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  15. Pharmacokinetics (PK) of XON7 (Part 1): Vd

    Volume of distribution (Vd) is defined as the total amount of XON7 in the body divided by its concentration in plasma

    Measured: Cycle 1-Day 1 Predose and Postdose: 5 minutes; 1; 2; 4; 8; 24; 72 or 96; 144 hours after the end of infusion. Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 7 Day 1: Predose and 5 minutes after the end of infusion

  16. Pharmacokinetics (PK) of XON7 (Part 2): Vd

    Volume of distribution (Vd) is defined as the total amount of XON7 in the body divided by its concentration in plasma

    Measured: Cycle 1-Day 1; Cycle 2-Day 1; Cycle 3-Day 1; Cycle 6-Day 1; Cycle 9-Day1 and Cycle 12-Day 1: Predose and 5 minutes after the end of infusion

  17. Host immunogenicity to XON7 (Part 1 and part 2)

    Number of participants who develop detectable anti-drug antibodies

    Measured: Cycle 1-Day 1; Cycle 1-Day4; Cycle 1-Day7; Cycle 1-Day15; Cycle 2 and additional cycles-Day1; 30 and 60 days after the last dose of XON7

  18. Host immunogenicity to XON7 (Part 1 and part 2)

    Percentage of participants who develop detectable anti-drug antibodies

    Measured: Cycle 1-Day 1; Cycle 1-Day4; Cycle 1-Day7; Cycle 1-Day15; Cycle 2 and additional cycles-Day1; 30 and 60 days after the last dose of XON7

  19. Further assess anti-tumor efficacy (Part 1): ORR

    Objective response rate (ORR): defined as the proportion of participants with a confirmed complete response [CR] or confirmed partial response [PR] assessed by investigators according to RECIST v1.1. within 3 months after XON7 initiation

    Measured: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice

  20. Further assess anti-tumor efficacy (Part 2): CBR

    Clinical Benefit Rate (CBR) defined as the proportion of participants who achieve CR, PR, and durable SD [SD≥24 weeks] assessed by investigators according to the RECIST criteria v 1.1.

    Measured: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice

  21. Further assess anti-tumor efficacy (Part 1 and part 2): DCR

    Disease control rate (DCR): defined as the proportion of participants who achieve confirmed complete response [CR], confirmed partial response [PR] or stable disease [SD] assessed by investigators according to the RECIST criteria version 1.1.

    Measured: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice

  22. Further assess anti-tumor efficacy (Part 1 and part 2): DoR

    Duration of response (DoR): defined as the time interval between the first confirmed objective response (CR or PR per RECIST 1.1 by investigators) and the first occurrence of objective tumor progression (Progressive disease (PD) per RECIST 1.1 by investigators) or death from any cause.

    Measured: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice

  23. Further assess anti-tumor efficacy (Part 2): TTR

    Time to response (TTR): defined as the time from the date of XON7 initiation to first confirmed objective response (CR or PR per RECIST 1.1 by investigators)..

    Measured: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice

  24. Further assess anti-tumor efficacy (Part 1 and part 2): PFS

    Progression-free survival (PFS): defined as the time from the date of XON7 initiation to the date of first documented progression (RECIST 1.1 by investigators) or death.

    Measured: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice

  25. Further assess anti-tumor efficacy (Part 1 and part 2): OS

    Overall survival (OS): defined as the time interval between the date of XON7 initiation and the date of death due to any cause.

    Measured: Tumor imaging (computed tomography [CT]) will be performed within 28 days prior to enrollment, and while on study approximately every 8 weeks during the treatment period. During the survival follow-up, results of CT only performed in current practice

  26. Expansion part: treatment emergent adverse events (TEAEs)

    An overall summary of AE occurrences with onset during the first treatment cycle will be presented; this will include the following AE attributes:

    • Preferred term,
    • Maximum CTCAE grade,
    • Outcome,
    • Time to first occurrence [days].

    Measured: Participants will be assessed for AEs and SAEs beginning immediately after the first dose of investigational drug and continuing through to follow-up which is 60 ± 5 days of last dose of investigational drug.

  27. Dose Escalation part: clinically significant findings in blood pressure (BP)

    Incidence and severity of clinically significant findings in blood pressure: Significant blood pressure increase will be defined as BP >150/100 mmHg in a subject without a history of hypertension or increased >20 mmHg (diastolic) from baseline measurement in a subject with a previous history of hypertension.

    Measured: Before and immediately after the first dose of investigational drug and continuing through to follow-up which is 60 ± 5 days of last dose of investigational drug

  28. Dose Escalation part: clinically significant findings in electrocardiogram (ECGs)

    Incidence of clinically significant findings in Electrocardiogram (ECG): Significant QTc prolongation will be defined as an interval ≥500 msec or an interval which increases by ≥60 msec over baseline

    Measured: Before and immediately after the first dose of investigational drug and continuing through to follow-up which is 60 ± 5 days of last dose of investigational drug

  29. Expansion part: clinically significant changes in Leucocytes count

    Incidence and magnitude of clinically significant changes in Leucocytes Count (G/L)

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

  30. Expansion part: clinically significant changes in Red Blood Cells Count

    Incidence and magnitude of clinically significant changes in Red Blood Cells Count (T/L)

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

  31. Expansion part: clinically significant changes in Hemoglobin

    Incidence and magnitude of clinically significant changes in Hemoglobin (g/dL).

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

  32. Expansion part: clinically significant changes in Hematocrit

    Incidence and magnitude of clinically significant changes in Hematocrit (%).

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

  33. Expansion part: clinically significant changes in Absolute Neutrophil Count

    Incidence and magnitude of clinically significant changes in Absolute Neutrophil Count (G/L).

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

  34. Expansion part: clinically significant changes in Absolute Eosinophil Count

    Incidence and magnitude of clinically significant changes in Absolute Eosinophil Count (G/L).

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

  35. Expansion part: clinically significant changes in Absolute Basophil Count

    Incidence and magnitude of clinically significant changes in Absolute Basophil Count (G/L).

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

  36. Expansion part: clinically significant changes in Absolute Lymphocytes Count

    Incidence and magnitude of clinically significant changes in Absolute Lymphocytes Count (G/L).

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

  37. Expansion part: clinically significant changes in Absolute Monocytes Count

    Incidence and magnitude of clinically significant changes in Absolute Monocytes Count (G/L).

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

  38. Expansion part: clinically significant changes in Platelet Count

    Incidence and magnitude of clinically significant changes in Platelet Count (G/L).

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

  39. Expansion part: clinically significant changes in Albumin

    Incidence and magnitude of clinically significant changes in Albumin (g/L).

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

  40. Expansion part: clinically significant changes in Bicarbonate

    Incidence and magnitude of clinically significant changes in Bicarbonate (mmol/L).

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

  41. Expansion part: clinically significant changes in Total Bilirubin

    Incidence and magnitude of clinically significant changes in Total Bilirubin (µmol/L).

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

  42. Expansion part: clinically significant changes in Calcium

    Incidence and magnitude of clinically significant changes in Calcium (mmol/L).

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

  43. Expansion part: clinically significant changes in Urea

    Incidence and magnitude of clinically significant changes in Urea (mmol/L).

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

  44. Expansion part: clinically significant changes in Chloride

    Incidence and magnitude of clinically significant changes in Chloride (mmol/L).

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

  45. Expansion part: clinically significant changes in Creatinine

    Incidence and magnitude of clinically significant changes in Creatinine (µmol/L).

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

  46. Expansion part: clinically significant changes in Creatinine Clearance

    Incidence and magnitude of clinically significant changes in Creatinine Clearance (mL/min).

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

  47. Expansion part: clinically significant changes in Glucose

    Incidence and magnitude of clinically significant changes in Glucose (mmol/L).

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

  48. Expansion part: clinically significant changes in Magnesium

    Incidence and magnitude of clinically significant changes in Magnesium (mmol/L).

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

  49. Expansion part: clinically significant changes in Phosphate

    Incidence and magnitude of clinically significant changes in Phosphate (mmol/L).

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

  50. Expansion part: clinically significant changes in Potassium

    Incidence and magnitude of clinically significant changes in Potassium (mmol/L).

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

  51. Expansion part: clinically significant changes in Sodium

    Incidence and magnitude of clinically significant changes in Sodium (mmol/L).

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

  52. Expansion part: clinically significant changes in Total Protein

    Incidence and magnitude of clinically significant changes in Total Protein (g/L).

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

  53. Expansion part: clinically significant changes in Alanine aminotransferase (ALT)

    Incidence and magnitude of clinically significant changes in Alanine aminotransferase (ALT) (U/L).

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

  54. Expansion part: clinically significant changes in Aspartate aminotransferase (AST)

    Incidence and magnitude of clinically significant changes in Aspartate aminotransferase (AST) (U/L).

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

  55. Expansion part: clinically significant changes in Gamma-glutamyl transférase (GGT)

    Incidence and magnitude of clinically significant changes in Gamma-glutamyl transférase (GGT) (U/L).

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

  56. Expansion part: clinically significant changes in Alkaline Phosphatase (ALP)

    Incidence and magnitude of clinically significant changes in Alkaline Phosphatase (ALP) (U/L).

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

  57. Expansion part: clinically significant changes in Lactate dehydrogenase (LDH)

    Incidence and magnitude of clinically significant changes in Lactate dehydrogenase (LDH) (U/L).

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

  58. Expansion part: clinically significant changes in Amylase

    Incidence and magnitude of clinically significant changes in Amylase (U/L).

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

  59. Expansion part: clinically significant changes in Lipase

    Incidence and magnitude of clinically significant changes in Lipase (U/L).

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

  60. Expansion part: clinically significant changes in Total Protein Creatine Kinase (CK)

    Incidence and magnitude of clinically significant changes in Total Protein Creatine Kinase (CK) (U/L).

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

  61. Expansion part: clinically significant changes in Creatine kinase - cardiac muscle isoenzyme (CK-MB)

    Incidence and magnitude of clinically significant changes in Creatine kinase - cardiac muscle isoenzyme (CK-MB) (U/L).

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

  62. Expansion part: clinically significant changes in Troponin T

    Incidence and magnitude of clinically significant changes in Troponin T (ng/L).

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

  63. Expansion part: clinically significant changes in Prothrombin Time (PT)

    Incidence and magnitude of clinically significant changes in Prothrombin Time (PT) (Sec).

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

  64. Expansion part: clinically significant changes in INR (if under VKA Therapy)

    Incidence and magnitude of clinically significant changes in INR (if under VKA Therapy)

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

  65. Expansion part: clinically significant changes in Activated Partial Thromboplastin Time (aPTT)

    Incidence and magnitude of clinically significant changes in Activated Partial Thromboplastin Time (aPTT) (Sec).

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

Timeline

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

  1. First posted4 Dec 2023
  2. Study start14 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionNov 2027 (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
Not applicable
Intervention model
Single group
Model description
The Part I component is a multicenter, open-label, multiple-dose, dose escalation, first-in-human study. Six dose levels are planned: 1.5; 3; 6; 12; 16 and 20mg/kg, Q2W (once every two weeks). Up to 45 participants with relapsed or refractory, advanced or metastatic solid tumors will be included. The Part II component is a multi-center, open-label, non-randomized, multi-cohorts, expansion trial with adaptive design. The selected cohorts of the study will investigate RP2D to determine the anti-tumors efficacy, safety, and tolerability of XON7 in participants with relapsed or refractory, advanced or metastatic solid tumors after failure to standard of care treatments. Up to 7 cohorts could be investigated. A maximum of 30 participants will be enrolled in each cohort.
Masking
None (open label)
Enrolment
255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06154291
Sponsor's protocol ID
XT 23-01
Other IDs
2023-505266-29-00, 2023
Acronym
FIPO23
Status last verified
Aug 2026
First submitted
6 Nov 2023
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XON7 in people with Advanced Solid Tumor and Metastatic Cancer, run by Xenothera SAS at 5 sites in 2 countries.

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 16 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Belgium. 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. 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?

Contact Françoise SHNEIKER, MD (+33652720301, francoise.shneiker@xenothera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation part: Dose Limiting Toxicities (DLTs) (time frame: At the end of Cycle 1 (28 days)). The study lists 42 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 NCT06154291.

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 20 Aug 2026.

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