To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors

Study consists of three arms, Arm A is a Phase Ib/II study of TT-00420 tablet monotherapy, Arm B is a Phase Ib/II study of TT-00420 tablet in combination with atezolizumab (Tecentriq®), and Arm C is a Phase Ib/II study of TT-00420 tablet in combination with nab-paclitaxel (Abraxane®). Arm A: TT-00420 Tablet Monotherapy Phase Ib will enroll patients with preferred indications including advanced cholangiocarcinoma, small cell lung cancer, HER2-negative breast cancer including TNBC, bladder cancer, prostate cancer, thyroid cancer, gastric cancer, gallbladder cancer and other advanced solid tumors to receive TT-00420 monotherapy. Phase Ib will be a dose escalation study of TT-00420 in combination, guided by 3+3 design, to determine a Recommended Phase 2 Dose (RP2D). Based on preliminary efficacy results, Phase II will enroll additional patients in select indications to evaluate the efficacy of TT-00420 monotherapy. Arm B: TT-00420 tablet in combination with atezolizumab (Tecentriq®) Arm B will enroll patients with advanced biliary tract cancer. Phase Ib will be a dose escalation study of TT-00420 in combination with nab-paclitaxel, guided by 3+3 design, to determine a Recommended Phase 2 Dose (RP2D). Phase II will enroll additional patients with advanced biliary tract cancer to further evaluate the efficacy of the combination regimen. Arm C: TT-00420 tablet in combination with nab-paclitaxel (Abraxane®) Arm C will enroll patients with advanced triple-negative breast cancer (TNBC). Phase Ib will be a dose escalation study of TT-00420 in combination with nab-paclitaxel, guided by 3+3 design, to determine a Recommended Phase 2 Dose (RP2D). Phase II will enroll additional patients with advanced TNBC to further evaluate the efficacy of the combination regimen.