Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
255 participants
INTERVENTIONAL
2023-11-14
2027-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
NCT03478995
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
NCT03517488
A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
NCT02697591
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
NCT07123103
An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers
NCT02648490
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose Escalation part then Expansion part
Dose 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
XON7
The trial intervention (XON7) is a glyco-humanized polyclonal antibody drug which is formulated for intravenous (IV) administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
XON7
The trial intervention (XON7) is a glyco-humanized polyclonal antibody drug which is formulated for intravenous (IV) administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xenothera SAS
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jaafar BENNOUNA, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Foch
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Jules Bordet
Anderlecht, , Belgium
Institut Bergonié
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
Hôpital Foch
Suresnes, , France
IUCT-Oncopole
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505266-29-00
Identifier Type: OTHER
Identifier Source: secondary_id
XT 23-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.