{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT07662928","title":"Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BEDROCK Study","sponsor":"AIDS Malignancy Consortium","phases":["PHASE2"],"status":"NOT_YET_RECRUITING","indication":null,"disease":"adult-onset Still disease"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"no","detail":"None of MS4A1, CD3E, CD3G has somatic-mutation evidence in adult-onset Still disease","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: MS4A1 in adult-onset Still disease","url":"https://platform.opentargets.org/evidence/ENSG00000156738/MONDO_0019355","date":"2026-11-11T21:56:35.032Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"no","detail":"No germline or somatic evidence for MS4A1, CD3E, CD3G in adult-onset Still disease","rule":"Any germline or somatic human genetic evidence for the target in this cancer, counted apart from animal-model and literature evidence","source":{"label":"Open Targets: MS4A1 in adult-onset Still disease","url":"https://platform.opentargets.org/evidence/ENSG00000156738/MONDO_0019355","date":"2026-11-11T21:56:35.032Z"},"context":[]},{"id":"pediatric_target","label":"Pediatric target","value":"yes","detail":"MS4A1 on the FDA list","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"yes","detail":"Haematologic","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928","date":"2026-11-11T21:56:35.032Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"Background therapy","text":"Cyclophosphamide, Doxorubicin, Etoposide, Rituximab, Vincristine: standard agents, not counted in these flags."},{"label":"MS4A1 (via Epcoritamab)","text":"Open Targets has no association between MS4A1 and adult-onset Still disease.","source":{"label":"Open Targets: MS4A1 in adult-onset Still disease","url":"https://platform.opentargets.org/evidence/ENSG00000156738/MONDO_0019355","date":"2026-11-11T21:56:35.032Z"}},{"label":"CD3E (via Epcoritamab)","text":"Open Targets has no association between CD3E and adult-onset Still disease.","source":{"label":"Open Targets: CD3E in adult-onset Still disease","url":"https://platform.opentargets.org/evidence/ENSG00000198851/MONDO_0019355","date":"2026-11-11T21:56:35.032Z"}},{"label":"CD3G (via Epcoritamab)","text":"Open Targets has no association between CD3G and adult-onset Still disease.","source":{"label":"Open Targets: CD3G in adult-onset Still disease","url":"https://platform.opentargets.org/evidence/ENSG00000160654/MONDO_0019355","date":"2026-11-11T21:56:35.032Z"}}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"yes","detail":"Randomised allocation","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928","date":"2026-11-11T21:56:35.032Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"no","detail":"43 planned; each patient moves a rate by 100 ÷ 43 = 2.3 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928","date":"2026-11-11T21:56:35.032Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"yes","detail":"Proportion of participants who complete at least Cycle 3 among 10 participants (Feasibility); Overall survival","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928","date":"2026-11-11T21:56:35.032Z"},"context":[]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2031-05-30; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928","date":"2026-11-11T21:56:35.032Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[{"label":"Stopped on this target","text":"123 terminated, withdrawn or suspended trials of drugs against MS4A1; 6 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"MS4A1: what already stopped","url":"/target/ENSG00000156738#stopped","date":"2026-11-11T21:56:35.048Z"}}],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"yes","detail":"The only site is in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928?tab=locations","date":"2026-11-11T21:56:35.032Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-002907-PIP01-20-M03 (Epcoritamab, Treatment of mature B-cell malignancies): PM: decision on the application for modification of an agreed PIP, 27 Jun 2024","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA EMEA-002907-PIP01-20-M03","url":"https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002907-pip01-20-m03","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/22/2634 withdrawn 21 Jun 2022: Treatment of follicular lymphoma; EU/3/22/2581 withdrawn 24 Feb 2022: Treatment of diffuse large B-cell lymphoma","rule":"An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-orphan_designations-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Tepkinly: authorised since 22 Sept 2023, conditional","rule":"An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file","source":{"label":"EMA EPAR Tepkinly","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tepkinly","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"fda_orphan","label":"FDA orphan designation","value":"not published","detail":"FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link","rule":"Would be: an FDA orphan designation names the drug","source":{"label":"FDA orphan designations search","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/","date":""},"context":[]},{"id":"fda_ped_approval","label":"FDA pediatric oncology approval","value":"no","detail":"FDA's table lists no pediatric approval of Epcoritamab","rule":"FDA's Pediatric Oncology Drug Approvals table names the drug","source":{"label":"FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03)","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals","date":"2026-11-11T21:56:35.063Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"2 interventional studies of Epcoritamab include patients under 18; 2 are recruiting, not yet recruiting or active","rule":"The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age","source":{"label":"ClinicalTrials.gov search","url":"https://clinicaltrials.gov/search?intr=%22Epcoritamab%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T21:56:35.071Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Rare pediatric disease voucher","text":"FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news.","source":{"label":"FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs","url":"https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs","date":"2026-11-11"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"AIDS Malignancy Consortium (academic or other)","source":{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928","date":"2026-11-11T21:56:35.032Z"}},{"label":"principal investigator","text":"Ariela Noy, AIDS Malignancy Consortium","source":{"label":"Person page","url":"/person/Ariela%20Noy","date":"2026-11-11T21:56:35.032Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT07662928","url":"https://clinicaltrials.gov/study/NCT07662928","date":"2026-11-11T21:56:35.032Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T21:56:35.032Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T21:56:35.026Z"}