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

NCT05253053 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-06-12

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • TransThera Sciences (Nanjing), Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05253053 on ClinicalTrials.gov