[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658905":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":11,"studyPopulation":11,"armGroups":30,"interventions":54,"overallOfficials":83,"centralContacts":88,"locations":11,"responsibleParty":96,"collaborators":11,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":11,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":11,"enrollmentInfo":107,"targetDuration":11,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":119,"whyStopped":11,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":11},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Adverse Events (AEs)",null,"Up to approximately 30 months",{"measure":14,"description":11,"timeFrame":15},"Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)","Up to Day 28",[17,19,21],{"measure":18,"description":11,"timeFrame":12},"Objective Response Rate (ORR)",{"measure":20,"description":11,"timeFrame":12},"Duration of Response (DOR)",{"measure":22,"description":11,"timeFrame":12},"Progression-free Survival (PFS) After Randomization",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":11,"timePerspective":11,"maskingInfo":28},"RANDOMIZED","SEQUENTIAL","The study design includes both parallel and sequential interventional models.","TREATMENT",{"masking":29,"maskingDescription":11,"whoMasked":11},"NONE",[31,39,44,49],{"label":32,"type":33,"description":34,"interventionNames":35},"Group A: GDC-7035 + mFOLFOX6 + Panitumumab","EXPERIMENTAL","Participants with CRC will receive GDC-7035 in combination with modified (levo)leucovorin, 5-fluorouracil (5-FU), oxaliplatin (mFOLFOX6) and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with mFOLFOX6 and panitumumab at doses determined to be safe in the safety run-in period.",[36,37,38],"Drug: GDC-7035","Biological: Panitumumab","Drug: mFOLFOX6",{"label":40,"type":33,"description":41,"interventionNames":42},"Group B: GDC-7035 + FOLFIRI + Panitumumab","Participants with CRC will receive GDC-7035 in combination with leucovorin, 5-FU, irinotecan (FOLFIRI), and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with FOLFIRI and panitumumab at doses determined to be safe in the safety run-in period.",[36,37,43],"Drug: FOLFIRI",{"label":45,"type":33,"description":46,"interventionNames":47},"Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy","Participants with PDAC will receive GDC-7035 in combination with modified leucovorin, 5-FU, irinotecan, oxaliplatin (mFOLFIRINOX) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with mFOLFIRINOX at doses determined to be safe in the safety run-in period.",[36,48],"Drug: mFOLFIRINOX",{"label":50,"type":33,"description":51,"interventionNames":52},"Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy","Participants with PDAC will receive GDC-7035 in combination with gemcitabine and nab-paclitaxel (Gem-nabP) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with Gem-nabP at doses determined to be safe in the safety run-in period.",[36,53],"Drug: Gem-nabP",[55,62,67,71,75,79],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","GDC-7035","Participants will receive GDC-7035 as per the schedule specified in the protocol.",[32,40,45,50],[61],"RO7782493",{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":11},"BIOLOGICAL","Panitumumab","Participants will receive panitumumab in accordance with the local prescribing information.",[32,40],{"type":56,"name":68,"description":69,"armGroupLabels":70,"otherNames":11},"mFOLFOX6","Participants will receive mFOLFOX6 in accordance with the local prescribing information.",[32],{"type":56,"name":72,"description":73,"armGroupLabels":74,"otherNames":11},"FOLFIRI","Participants will receive FOLFIRI in accordance with the local prescribing information.",[40],{"type":56,"name":76,"description":77,"armGroupLabels":78,"otherNames":11},"mFOLFIRINOX","Participants will receive mFOLFIRINOX in accordance with the local prescribing information.",[45],{"type":56,"name":80,"description":81,"armGroupLabels":82,"otherNames":11},"Gem-nabP","Participants will receive Gem-nabP in accordance with the local prescribing information.",[50],[84],{"name":85,"affiliation":86,"role":87},"Clinical Trials","Hoffmann-La Roche","STUDY_DIRECTOR",[89,94],{"name":90,"role":91,"phone":92,"phoneExt":11,"email":93},"Reference Study ID Number: GO46205 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":95,"role":91,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":97,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658905","phase-1-a-study-to-evaluate-the-safety-and-activity-of-gdc-7035-with-anti-cancer-therapies-in-participants-with-kras-g12d-mutated-unresectable-advanced-or-metastatic-colorectal-cancer-or-pancreatic-ductal-adenocarcinoma-100658905",false,"NCT07859085","A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma","A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing\n* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm\n\nExclusion Criteria:\n\n* Malabsorption syndrome or other conditions that would interfere with enteral absorption\n* Known and untreated, or active central nervous system (CNS) metastases\n* Known clinically significant liver disease\n* History of or active clinically significant cardiovascular dysfunction\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":108,"type":109},388,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized\u002Fexpansion period.",[115,116],"Colorectal Neoplasms","Pancreatic Ductal Adenocarcinoma",[118],"KRAS G12D-mutation","NOT_YET_RECRUITING","2026-09-29",{"date":122,"type":123},"2026-10-05","ACTUAL",{"date":125,"type":109},"2026-10-31",{"date":127,"type":109},"2029-03-30",{"name":5,"class":6}]