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Tests treatment safety and results for Solid Tumor Malignancies
Official title Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors.
ClinicalTrials.gov ID: NCT07303387
What this study is testing
What is Valemetostat Tosylate?
Valemetostat Tosylate is an investigational medicine, being studied as a potential treatment for solid tumor malignancies.
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
- Rational, objective and design: Some cancer-protecting genes are inactivated when the EZH2 enzyme is too active or the SWI/SNF complex is less active. The EZH1/2 enzymes and the SWI/SNFs complex play opposing roles in gene expression: we hypothesize that valemetostat, an inhibitor of the EZH1/2 enzymes, will stop/slow down the growth of cancer cells by reactivating these genes.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
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
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
- Ability to comply with the protocol.
- Age ≥ 18 years.
- Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type)...
- Evidence of disease progression prior to trial entry.
You likely can't join if
- Participation in another clinical study with an investigational product during the last 4 weeks (excepting observational or non-treatment clinical...
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor...
- Participant has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks prior to Cycle 1 Day 1; or curative radiation therapy or...
- History of another primary malignancy within 5 years prior to Cycle 1 Day 1 except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for...
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
See the full eligibility criteria
Who can join
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
- Ability to comply with the protocol.
- Age ≥ 18 years.
- Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type). Diagnosis must be stated in a pathology report and confirmed by the...
- Evidence of disease progression prior to trial entry.
- Have exhausted all other standard-of-care therapeutic options which have shown how well it works in their disease and are expected to be more effective than valemetostat based on current evidence for standard-of-care...
- Have an archival tissue sample available with sufficient tumor tissue for IHC confirmation of loss expression (20 slides required). If patients do not have sufficient archival material, a new biopsy should be scheduled.
- Have documented bi-allelic (homozygous) deletion of SMARCB1, SMARCA4/2, ARID1A/B, PBRM1, BAP1, SMARCC1/2 or other SWI/SNF in a tumor detected by a validated NGS test (solid or liquid) and confirmed loss of expression in...
- At least one lesion, not previously irradiated, measurable according to RECIST v1.1 (PCWG3/RECIST1.1 for prostate cancer and mRECIST for pleural mesothelioma) as ≥10 mm in the longest diameter (except lymph nodes which...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration at the time of enrollment.
- Estimated life expectancy of greater than 12 weeks.
- Adequate hematologic and organ function, defined by the following laboratory results obtained within 3 days prior to the first study treatment (Cycle 1 Day 1):
- Absolute neutrophil count (ANC) ≥ 1500 cells/μL (without granulocyte colony-stimulating factor support within 14 days prior to the screening assessment).
- Lymphocyte count ≥ 500/μL.
- Platelet count ≥ 100.000/μL (platelet transfusion is not allowed within 14 days prior to the screening assessment).
- Hemoglobin ≥ 9g/dL (packed red blood cell transfusion is not allowed within 14 days prior to the screening assessment).
- Total bilirubin ≤ 1.5 ULN (people with documented/suspected Gilbert's disease can have total bilirubin ≤3x ULN and direct bilirubin ≤1.5x ULN or people with liver metastases at baseline can have total bilirubin ≤ 3 ×...
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 3.0x upper normal limit (ULN) or ≤ 5 × ULN in case of liver metastases.
- Albumin ≥ 2.5g/dL.
- Creatinine clearance ≥ 40 mL/min (according to Cockroft and Gault formula).
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic...
- Women of childbearing potential must have at least one negative serum β-HCG pregnancy test during the screening assessment. Prior to the administration of the first study treatment, there must be a negative serum β-HCG...
- Sexually active women of childbearing potential must agree to use a highly effective method of contraception \ \>, or to abstain from sexual activity during the study and for at least 3 months after the last dose of...
- Participant must agree to not breastfeed during the study or for 3 months after the last dose of study treatment.
- Sexually active male's patients with partner of childbearing potential, the subject must be surgically sterile or willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 3...
- Participant must agree to not donate blood during the study or for 3 months days after the last dose of study treatment.
- Male people must not freeze or donate sperm starting at Screening and throughout the study period, and for at least 3 months after the final study drug administration.
- Female people must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration.
- Patient should be able and willing to comply with study visits and procedures as per protocol.
- Patients must be affiliated to a social security system or beneficiary of an equivalent system.
What rules you out
- Participation in another clinical study with an investigational product during the last 4 weeks (excepting observational or non-treatment clinical studies).
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 21 days prior...
- Participant has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks prior to Cycle 1 Day 1; or curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2...
- History of another primary malignancy within 5 years prior to Cycle 1 Day 1 except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease (eg, carcinoma in situ of the cervix, ductal carcinoma in situ treated surgically with curative intent).
- Treatment with systemic (\>10 mg daily prednisone equivalents). or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide...
- Acute toxicities from previous therapies that have not resolved to Grade ≤ 1, with the exception of alopecia.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. Known or suspected hypersensitivity to valemetostat tosylate or any of the excipients.
- Uncontrolled or significant cardiovascular disease, including the following:
- Evidence of prolongation of QT/QTc interval (eg, repeated episodes of QT corrected for heart rate using Fridericia's method [QTcF] \>470 ms) (average of triplicate determinations) refer to APPENDIX 9.
- Myocardial infarction within 6 months prior to Screening.
- Uncontrolled angina pectoris within 6 months prior to Screening.
- New York Heart Association (NYHA) Class 3 or 4 congestive heart failure.
- Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg).
- Patients with known left ventricular ejection fraction (LVEF) \< 40%; patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF \< 50% must be on a stable cardiologic...
- Known positive test for HIV or known acquired immunodeficiency syndrome
- Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection within 28 days prior to the first dose of study drug (hepatitis B surface antigen positive or have detectable HBV DNA or...
- Active tuberculosis.
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous antibiotics, antivirals, or antifungals. Note: people with localized fungal infections of skin or...
- Any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the investigator, including, but not limited to, bleeding diatheses
- Current use of moderate or strong cytochrome P450 (CYP)3A inducers (Table 8)
- Administration of attenuated or live vaccine within 4 weeks prior to Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study (except anti-COVID-19 vaccines).
- Major surgical procedure within 20 days prior ty Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study.
- Uncontrolled tumor-related pain: patients requiring pain medication must be on a stable regimen at study entry and symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment.
- Uncontrolled effusion (pleural, pericardial or ascites) requiring recurrent drainage procedures (once a month or more frequently); patients with indwelling catheters (e.g. PleurX) are allowed.
- Uncontrolled hypercalcemia (\>1.5mmol/L ionized calcium or Ca \> 12mg/dL or corrected serum calcium \>ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
- History of leptomeningeal disease
- Symptomatic CNS metastasis or uncontrolled CNS metastasis, requiring increasing doses of steroids or stable dose of steroids \> 10mg prednisone QD.
- Spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to Cycle 1 Day 1.
- Female people who are pregnant, breast-feeding or male / female patients of reproductive potential who are not employing an effective method of birth control.
- Previous treatment with EZH2 (or EZH1/2) inhibitors, except for cohort 1A where EZH2 inhibitors are approved.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study result.
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, Val de Marne, France
- Bordeaux, France
- Lyon, France
- Paris, 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 study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Villejuif, Val de Marne, France; Bordeaux, France; Lyon, France; Paris, 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.