A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer

The trial was divided into two phases. Stage I (Phase Ib): Part A: Monotherapy Period:In the phase Ib Part A monotherapy period, a small number of TNBC patients were planned to be enrolled to receive LBL-024 monotherapy.The safety, tolerability, and preliminary efficacy of LBL-024 monotherapy in this population will be assessed by the sponsor and investigator in combination. Part B: Combination Drug Safety Run-In Period:If the safety and tolerability are good and there is preliminary efficacy in Part A,The investigator discussed with the sponsor to decide whether to continue the study in Part B of Phase Ib.Part B is designed to enroll a small number of TNBC patients to receive LBL-024 combination therapy. Stage II (Phase II) ： If the safety and tolerability are good and there is preliminary efficacy in the first stage,The investigator discusses with the sponsor to decide whether to continue the co-administration expansion study, continue to enroll TNBC patients, and using a randomized, open, positive control trial design. This study will enroll up to 220 subjects.