Informations générales (source: ClinicalTrials.gov)
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 (FIPO23)
Interventional
Phase 1/Phase 2
Xenothera SAS (Voir sur ClinicalTrials)
novembre 2023
novembre 2027
08 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 05/05/2025 07:12:15 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69003 - Lyon - France | Jean-Yves BLAI, MD | Contact (sur clinicalTrials) | |||
| IUCT-Oncopole - 31100 - Toulouse - France | Jean-Pierre DELORD, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
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)