NCT05253053

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

A Phase Ib/II Study of TT-00420 Tablet, as Monotherapy or in Combination Regimens, to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumor

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors (solid tumor, BTC and TNBC).

Detailed description

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.

Conditions

• Advanced Solid Tumor
• Cholangiocarcinoma
• Biliary Tract Cancer
• HER2-negative Breast Cancer
• Triple Negative Breast Cancer
• Small-cell Lung Cancer
• Bladder Cancer
• Prostate Cancer
• Thyroid Cancer
• Gastric Cancer
• Gallbladder Cancer

Interventions

Type	Name	Description
DRUG	TT-00420	TT-00420 tablet will be administered orally once daily per protocol defined schedule.
DRUG	Combination Product: Atezolizumab	Atezolizumab would be administered via infusion on Day 1 of 21-day cycle
DRUG	Combination Product: Nab-Paclitaxel	Nab-Paclitaxel would be administered via infusion on Day 1 and 8 of 21-day cycle

Timeline

• Start date: 2022-04-13
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2022-02-23
• Last updated: 2025-06-12

Locations

9 sites across 1 country: China