{"id":"hlx15-iv","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HLX15-IV targets programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing the suppressive signal that tumors use to evade the immune system. By blocking PD-L1, the drug allows T cells to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors and is designed to enhance endogenous anti-tumor immunity.","oneSentence":"HLX15-IV is a humanized monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:49.991Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation)"}]},"trialDetails":[{"nctId":"NCT05497804","phase":"PHASE2","title":"Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mayo Clinic","startDate":"2022-09-22","conditions":"ISS Stage III Plasma Cell Myeloma, Multiple Myeloma","enrollment":17},{"nctId":"NCT07072585","phase":"PHASE2, PHASE3","title":"Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)","status":"NOT_YET_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2026-06-28","conditions":"Stage II T Lymphoblastic Leukemia/Lymphoma, Stage III T Lymphoblastic Leukemia/Lymphoma, Stage IV T Lymphoblastic Leukemia/Lymphoma","enrollment":1708},{"nctId":"NCT06785415","phase":"PHASE1, PHASE2","title":"Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2025-03-18","conditions":"Recurrent Multiple Myeloma","enrollment":37},{"nctId":"NCT06287944","phase":"PHASE1","title":"225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2025-07-01","conditions":"Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome","enrollment":15},{"nctId":"NCT06895512","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-04","conditions":"Newly Diagnosed Multiple Myeloma","enrollment":386}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"HLX15-IV","genericName":"HLX15-IV","companyName":"Shanghai Henlius Biotech","companyId":"shanghai-henlius-biotech","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HLX15-IV is a small molecule being studied in clinical trials for various blood cancers, including multiple myeloma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, and recurrent multiple myeloma. It is being compared to Darzalex in combination with lenalidomide-dexamethasone in a study for transplant-ineligible patients with newly diagnosed multiple myeloma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}