{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["maplirpacept"],["maplirpacept","azacitidine"],["maplirpacept","azacitidine","venetoclax"]],"indication":"advanced hematologic malignancies","name":"NCT03530683","nct_id":"NCT03530683","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03530683. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"In the phase 1a dose- escalation part for single-agent maplirpacept (PF-07901801), participants with Relapsing or Refractory (R/R) lymphoma will be enrolled in sequential dose cohorts to receive maplirpacept (PF-07901801) QW to characterize safety, tolerability, and PK; to determine the Maximum Tolerated Dose (MTD) or P1b Starting Dose (a dose lower than or equal to the single-agent MTD), and to gain preliminary evidence of antitumor activity.\n\nIn addition, participants with R/R Lymphoma may also be enrolled in a cohort to receive maplirpacept (PF-07901801) Q2W and a cohort to receive maplirpacept (PF-07901801) Q3W to characterize safety, tolerability, and PK; to determine the MTD; and to gain preliminary evidence of antitumor activity.","label":"maplirpacept (PF-07901801) Monotherapy","type":"EXPERIMENTAL"},{"description":"Cohort A1: participants with newly diagnosed TP53-mutated Acute Myelocytic Leukemia (AML) will be treated with maplirpacept (PF-07901801) QW + azacitidine.\n\nCohort A2: participants with newly diagnosed TP53-mutated AML will be treated with maplirpacept (PF-07901801) QW + azacitidine.","label":"Cohort A: maplirpacept (PF-07901801) + Azacitidine","type":"EXPERIMENTAL"},{"description":"Cohort B1: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax\n\nCohort B2: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax.","label":"Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax","type":"EXPERIMENTAL"},{"description":"Cohort D1: participants with Relapsing or Recurrent (R/R) CD20+ Diffuse Large B Cell Lymphoma (DLBCL) will be treated with maplirpacept (PF-07901801) QW, then an increased dose Q3W + an anti-CD20 targeting agent.\n\nCohort D2: participants with R/R CD20+ DLBCL will be treated with maplirpacept (PF-07901801) dosed QW for 4 weeks, then an increased dose Q3W + an anti-CD20 targeting agent.","label":"Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent","type":"EXPERIMENTAL"},{"description":"Cohort E1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with single agent maplirpacept (PF-07901801) QW.\n\nCohort E2: participants with R/R MM will be treated with single agent maplirpacept (PF-07901801) increased dose QW.","label":"Cohort E1 and E2: single agent maplirpacept (PF-07901801)","type":"EXPERIMENTAL"},{"description":"Cohort F1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with increasing doses of maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone.\n\nCohort F2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + isatuximab, carfilzomib and dexamethasone.\n\nCohort F3: participants with R/R MM will be treated with maplirpacept (PF-07901801) increased dose QW + isatuximab, carfilzomib and dexamethasone.","label":"Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone","type":"EXPERIMENTAL"},{"description":"Cohort C1: participants with Relapsing or Refractory (R/R) Multiple Myeloma (MM) will be treated with maplirpacept (PF-07901801) QW\n\n\\+ carfilzomib and dexamethasone.\n\nCohort C2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + carfilzomib and dexamethasone.\n\nCohort C3: participants with R/R MM will be treated with maplirpacept (PF-07901801) Q2W + carfilzomib and dexamethasone.","label":"Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-07-18","type":"ACTUAL"},"conditions":["Lymphoma","Multiple Myeloma","Acute Myeloid Leukemia","Diffuse Large B-Cell Lymphoma"],"enrollment":{"count":189,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Maplirpacept (PF-07901801)","otherNames":["SIRPα-IgG4 Fc","TTI-622"],"type":"DRUG"},{"name":"Azacitidine","otherNames":["VIDAZA"],"type":"DRUG"},{"name":"Venetoclax","otherNames":["VENCLEXTA"],"type":"DRUG"},{"name":"Carfilzomib","otherNames":["KYPROLIS"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Anti-CD20 Targeting agent","otherNames":["Ruxience or Rituxan"],"type":"DRUG"},{"name":"Isatuximab","otherNames":["Sarclisa"],"type":"DRUG"}],"last_update":"2024-09-03","lead_sponsor":"Pfizer","official_title":"A Phase 1a/1b Dose-Escalation and Expansion Trial of TTI-622 in Patients With Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma","overall_status":"TERMINATED","phases":["PHASE1"],"primary_completion_date":{"date":"2024-07-18","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1a: Number of adverse events (AE) by severity","timeFrame":"Through study completion, up to 18 months"},{"measure":"Phase 1a: Number of AEs by Frequency","timeFrame":"Through study completion, up to 18 months"},{"measure":"Phase 1a: Number of participants with Dose-Limiting Toxicities (DLT)","timeFrame":"Up to 21-42 days"},{"measure":"Phase 1b: Number of adverse events (AE) by severity","timeFrame":"Through study completion, up to 30 months"},{"measure":"Phase 1b: Number of adverse events (AE) by frequency","timeFrame":"Through study completion, up to 30 months"},{"measure":"Phase 1b: Number of participants with disease response","timeFrame":"Through study completion, up to 30 months"},{"measure":"Phase 1a: Maximum Tolerated Dose (MTD)","timeFrame":"Baseline (the start of each sequentially increased treatment dose), up to the 3rd evaluable patient completes DLT observation period of 21 or 42 days."},{"measure":"Phase 1b: Recommended dose of TTI-622 in combination with selected anticancer treatments","timeFrame":"Through study completion, up to 30 months"},{"measure":"Phase 1b: Recommended dose of TTI-622 as a single agent","timeFrame":"Through study completion, up to 30 months"},{"measure":"Number of participants with response assessments that show preliminary efficacy","timeFrame":"Through study completion, up to 30 months"}],"references":[],"start_date":{"date":"2018-05-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT03530683"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03530683"}