Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05253053
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2022-01-26
Brief Title:
To Evaluate Efficacy and Safety of TT-00420 Tinengotinib as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
Sponsor:
TransThera Sciences Nanjing Inc
Organization:
TransThera Sciences Nanjing Inc
Study Overview
Official Title:
A Phase IbII 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:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase IbII 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 IbII study of TT-00420 tablet monotherapy Arm B is a Phase IbII study of TT-00420 tablet in combination with atezolizumab Tecentriq and Arm C is a Phase IbII 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 33 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 33 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 33 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
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 33 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 33 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 33 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None