Study of TT-00420 Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 28
Summary
- Conditions
- Bladder Cancer
- Advanced Solid Tumor
- Cholangiocarcinoma
- Gallbladder Cancer
- Gastric Cancer
- HER2 Negative Breast Cancer
- Prostate Cancer
- Sarcoma
- Small Cell Lung Cancer
- Thyroid Cancer
- Triple -Negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Study will consist of two arms: Arm A (TT-00420 Tablet Monotherapy) and Arm B (TT-00420 tablet in combination with nab-paclitaxel (Abraxane®)).Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Study consists of two arms, Arm A is a Phase Ib/II study of TT-00420 tablet monotherapy, and Arm B 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 metastati...
Study consists of two arms, Arm A is a Phase Ib/II study of TT-00420 tablet monotherapy, and Arm B 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 metastatic cholangiocarcinoma, HER2-negative breast cancer including TNBC, bladder cancer, small cell lung cancer, prostate cancer, thyroid cancer, sarcoma, gastric cancer, gallbladder cancer and other advanced solid tumors to receive TT-00420 monotherapy. 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 nab-paclitaxel (Abraxane®) Arm B will enroll patients with metastatic HER2-negative breast cancers, including 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 metastatic HER2-negative breast cancers to further evaluate the efficacy of the combination regimen.
Tracking Information
- NCT #
- NCT04742959
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sarina A. Piha-Paul, MD M.D. Anderson Cancer Center