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New treatment option for Hepatocellular Carcinoma
Official title Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06551272
What this study is testing
What is EXL01?
EXL01 is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hepatocellular carcinoma (HCC) is the most common liver primary cancer with a high rate of mortality. Since the results of IMbrave150, immunotherapy have emerged as a standard of care for HCC patients advanced and/or unresectable in first line of treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and Female
- Age ≥18 years at time of signing informed consent
- Presenting with HCC, diagnosed either by histological or radiological criteria as described by EASL
- Locally advanced or metastatic and/or unresectable HCC according a Multidisciplinary Team meeting
- Progressive disease after exposure to standard-of-care approved first-line immunotherapy
You likely can't join if
- Partial response achieved under standard-of-care approved first-line immunotherapy
- CTCAE Grade ≥3 or more toxicity under standard-of-care approved first-line immunotherapy, or persistent toxicity Grade \>1
- Liver involvement \> 50%
- Presence of major macro vascular invasion (except Vp1/Vp2)
- Pregnant woman, or breastfeeding or women of child-bearing potential with no adequate contraception (see §4.3.1)
- Under curatorship, guardianship, safeguard of justice or deprived of liberty
See the full eligibility criteria
- Male and Female
- Age ≥18 years at time of signing informed consent
- Presenting with HCC, diagnosed either by histological or radiological criteria as described by EASL
- Locally advanced or metastatic and/or unresectable HCC according a Multidisciplinary Team meeting
- Progressive disease after exposure to standard-of-care approved first-line immunotherapy
- Decision made by the physician to continue the same standard-of-care approved first-line immunotherapy beyond progression
- Child-Pugh A within 7 days prior to inclusion
- ECOG performance status 0 to 1
- Adequate hematological (Hemoglobin \>8.5g/dL, platelets \>60G/L, neutrophils \>1.5G/L) and renal (creatinine clearance \> 50 mL/min according to Cockcroft or MDRD formula) functions
- Disease measurable by RECIST 1.1
- Signed written Informed consent
- Partial response achieved under standard-of-care approved first-line immunotherapy
- CTCAE Grade ≥3 or more toxicity under standard-of-care approved first-line immunotherapy, or persistent toxicity Grade \>1
- Liver involvement \> 50%
- Presence of major macro vascular invasion (except Vp1/Vp2)
- Pregnant woman, or breastfeeding or women of child-bearing potential with no adequate contraception (see §4.3.1)
- Under curatorship, guardianship, safeguard of justice or deprived of liberty
- History of serious autoimmune disease
- Interstitial lung disease
- HBV chronic infection with HBV DNA \> 100 IU/mL or without antiviral therapy; HBV patients with cirrhosis should be treated
- HIV infection
- Immunosuppression, including people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone equivalent)
- Transplanted liver, or patient with intent for transplantation
- Has difficulties in swallowing.
- Has undergone major surgery or significant trauma ≤4 weeks prior to Screening. Note: Participants who had surgery \>4 weeks prior to Screening must have recovered adequately from any toxicity and/or complications from...
- Is currently participating in or has participated in a study with an investigational compound or device within 3 months prior to the first dose of study intervention. Note: Participants who have entered the follow-up...
- Has a systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.
- Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the IB, and/or to soybean or soy-containing products
- Has a history of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
- Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea, or other inflammatory disease requiring...
- Current probiotics administration, or planned probiotics administration during treatment course.
- Specific contra-indication to the continuation of the standard-of-care approved first-line immunotherapy : 21.1: for atezolizumab-bevacizumab:
- Thromboembolic events in the 3 months prior to inclusion
- Prior bleeding event due to untreated or incompletely treated esophageal and / or gastric varices within 6 months' prior inclusion
- Has a history of hypersensitivity to the atezolizumab or to any of the excipients listed in section 6.1 of the SmPC of atezolizumab
- Has a history of hypersensitivity to bevacizumab or to any of the excipients listed in section 6.1 of the SmPC of bevacizumab
- Uncontrolled hypertension
- Clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure
- Proteinuria 21.2: for durvalumab:
- Has a history of hypersensitivity to the durvalumab or to any of the excipients listed in section 6.1 of the SmPC of durvalumab.
The study team makes the final eligibility decision.
Where it's taking place
- Bobigny, France
- Bordeaux, France
- Clichy, France
- Nantes, France
- Rennes, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bobigny, France; Bordeaux, France; Clichy, France; Nantes, France; Rennes, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.