{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT07549412","title":"A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","sponsor":"EMD Serono Research & Development Institute, Inc.","phases":["PHASE3"],"status":"RECRUITING","indication":{"slug":"colorectal","name":"Colorectal cancer"},"disease":"colorectal cancer"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"no","detail":"None of VEGFA, TYMP has somatic-mutation evidence in colorectal cancer","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: VEGFA in colorectal cancer","url":"https://platform.opentargets.org/evidence/ENSG00000112715/MONDO_0005575","date":"2026-11-11T17:18:26.955Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"no","detail":"No germline or somatic evidence for VEGFA, TYMP in colorectal cancer","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: VEGFA in colorectal cancer","url":"https://platform.opentargets.org/evidence/ENSG00000112715/MONDO_0005575","date":"2026-11-11T17:18:26.955Z"},"context":[]},{"id":"pediatric_target","label":"Pediatric target","value":"no","detail":"Not 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":"no","detail":"Solid tumour","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412","date":"2026-11-11T17:18:26.955Z"},"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":"VEGFA (via Bevacizumab)","text":"Evidence types in colorectal cancer: literature, rna_expression, clinical; literature listed separately from human genetics. Datasources: clinical_precedence, europepmc, expression_atlas.","source":{"label":"Open Targets: VEGFA in colorectal cancer","url":"https://platform.opentargets.org/evidence/ENSG00000112715/MONDO_0005575","date":"2026-11-11T17:18:26.955Z"}},{"label":"TYMP (via Trifluridine/Tipiracil)","text":"Evidence types in colorectal cancer: literature, clinical; literature listed separately from human genetics. Datasources: clinical_precedence, europepmc.","source":{"label":"Open Targets: TYMP in colorectal cancer","url":"https://platform.opentargets.org/evidence/ENSG00000025708/MONDO_0005575","date":"2026-11-11T17:18:26.955Z"}}],"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 NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412","date":"2026-11-11T17:18:26.955Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"no","detail":"1020 planned; each patient moves a rate by 100 ÷ 1020 = 0.1 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412","date":"2026-11-11T17:18:26.955Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"yes","detail":"Arm 1, 2 and 3: Overall Survival","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412","date":"2026-11-11T17:18:26.955Z"},"context":[]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2029-10-16; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412","date":"2026-11-11T17:18:26.955Z"},"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":"137 terminated, withdrawn or suspended trials of drugs against VEGFA; 28 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"VEGFA: what already stopped","url":"/target/ENSG00000112715#stopped","date":"2026-11-11T17:18:26.972Z"}}],"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":"no","detail":"116 sites in 19 countries; 22 in the United States (19%)","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412?tab=locations","date":"2026-11-11T17:18:26.955Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMA/PE/0000182333 (precemtabart tocentecan, Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)): W: decision granting a waiver in all age groups for all conditions or indications, 6 Dec 2024; EMEA-000056-PIP03-10-M02 (bevacizumab, Treatment of high-grade glioma): PM: decision on the application for modification of an agreed PIP, 22 Jan 2014; compliance positive 13 Nov 2015; EMEA-000056-PIP01-07-M02 (bevacizumab, Treatment of non-rhabdomyosarcoma soft tissue sarcoma;Treatment of rhabdomyosarcoma): PM: decision on the application for modification of an agreed PIP, 22 Jan 2014; compliance positive 26 Feb 2016","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-paediatric_investigation_plans-output-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/14/1390 positive 16 Dec 2014: Treatment of hereditary haemorrhagic telangiectasia","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 EU/3/14/1390","url":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-14-1390","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Mvasi: authorised since 15 Jan 2018; Aybintio: authorised since 19 Aug 2020; Orblid: application withdrawn, orphan medicine; Lytenava: authorised since 27 May 2024; +12 more","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 data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","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 Precemtabart tocentecan, Bevacizumab, Trifluridine/Tipiracil","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":"2026-11-11T17:18:26.984Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"171 interventional studies of Precemtabart tocentecan, Bevacizumab, Trifluridine/Tipiracil include patients under 18; 39 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=%22Precemtabart+tocentecan%22+OR+%22Bevacizumab%22+OR+%22Trifluridine%2FTipiracil%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T17:18:26.992Z"},"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":"EMD Serono Research & Development Institute, Inc. (industry)","source":{"label":"ClinicalTrials.gov NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412","date":"2026-11-11T17:18:26.955Z"}},{"label":"study director","text":"Medical Responsible, EMD Serono Research & Development Institute, Inc.","source":{"label":"Person page","url":"/person/Medical%20Responsible?ind=colorectal","date":"2026-11-11T17:18:26.955Z"}}],"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 NCT07549412","url":"https://clinicaltrials.gov/study/NCT07549412","date":"2026-11-11T17:18:26.955Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T17:18:26.955Z"},{"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":"2026-11-11T17:18:26.942Z"}