Actively Recruiting
FIH XON7 in Advanced/Metastatic Solid Tumors
Led by Xenothera SAS · Updated on 2025-06-22
255
Participants Needed
5
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FIH XON7 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed, written informed consent.
- Male or female participant aged 18 years or older.
- For Phase I: Histologically or cytologically confirmed advanced or metastatic solid tumors without effective standard therapy, excluding glioblastoma.
- For Phase II: Histologically or cytologically confirmed advanced or metastatic solid tumors of NSCLC, gastro-esophageal adenocarcinoma, colorectal cancer, pancreatic cancer, sarcoma, triple-negative breast cancer, or ovarian cancer.
- Solid tumors progressing after up to 4 lines of appropriate anticancer therapies or ineligible for them.
- Received approved targeted therapy if applicable for molecular alterations.
- Measurable disease per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy of at least 12 weeks.
- Adequate organ function.
- QTcF less than 450 msec or less than 480 msec with bundle branch block.
- In France, affiliation with or beneficiary of a social security category.
- Female participants not of child-bearing potential or with negative pregnancy test within 7 days before treatment.
- Female participants of child-bearing potential and all male partners must agree to use medically acceptable contraception including a barrier method during the trial and for 60 days after last dose.
- Male participants must agree to use adequate contraception during the trial and for 60 days after last dose.
- Phase II pharmacodynamics cohort participants must provide tumor biopsies as specified.
- Accessible tumor tissue available for fresh biopsy except for ovarian cancer and sarcoma in Phase II pharmacodynamics cohort.
You will not qualify if you...
- Received more than 4 prior lines of therapy for advanced or metastatic disease.
- Received anti-cancer monoclonal antibodies within 3 weeks before trial or not recovered from adverse events related to agents given more than 4 weeks prior.
- Received chemotherapy, targeted therapy, or radiation within 2 weeks before trial or not recovered from related adverse events (except specified exceptions).
- Experienced Grade 3 or higher toxicity from prior immunotherapy causing treatment stop.
- Toxicity from prior treatment not resolved to Grade 1 (except specified exceptions).
- Major surgery within 2 weeks before first dose or not recovered from surgery complications.
- Use of another experimental drug without adequate washout.
- Treatment with drugs known to prolong QT interval.
- Presence of carcinomatous meningitis.
- Central nervous system metastases unless previously treated, asymptomatic, and steroid-free for 3 weeks.
- Other malignancies within 3 years prior to first dose.
- History of autoimmune disease.
- Active or uncontrolled infections including HIV or hepatitis B/C.
- Severe or uncontrolled medical conditions affecting participation, including recent serious cardiac events.
- Prior bone marrow or solid organ transplantation.
- Active liver or biliary disease except specified exceptions.
- Use of systemic immunosuppressive medications within 28 days before first dose.
- Recent history of acute diverticulitis, inflammatory bowel disease, abscess, or gastrointestinal obstruction.
- History or presence of certain lung diseases including idiopathic pulmonary fibrosis or pneumonitis.
- Recent uncontrolled ascites or pleural effusions.
- Recent blood transfusions or colony stimulating factors within 2 weeks before first dose.
- Known drug or alcohol abuse.
- Female participants who are pregnant or lactating.
- Psychological, familial, sociological, or geographical conditions preventing protocol compliance.
- Inability or unwillingness to comply with trial or follow-up procedures.
- In France, patients under legal protection measures.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
3
Centre Léon Bérard
Lyon, France, 69003
Actively Recruiting
4
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
5
IUCT-Oncopole
Toulouse, France, 31100
Actively Recruiting
Research Team
F
Françoise SHNEIKER, MD
CONTACT
A
Alain BALEYDIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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