Trial · NCT04742959
Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
NCT04742959, Phase 1, Phase 2, Completed, TransThera Sciences (Nanjing), Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors. Trials, record NCT04742959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04742959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
- NCT number
- NCT04742959
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 203 participants, actual
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.
- Conditions
Advanced Solid Tumor, Cholangiocarcinoma, HER2-negative Breast Cancer, Triple Negative Breast Cancer, Bladder Cancer, Small-cell Lung Cancer, Prostate Cancer, Thyroid Cancer, Sarcoma, Gastric Cancer, Gallbladder Cancer
- Interventions
- TT-00420, Nab-Paclitaxel
- First posted
- 2021-02-08
- Last updated
- 2024-04-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | Up to 30 days from study discontinuation | As assessed per NCI Common Toxicity Criteria for Adverse Events, version 5.0 |
| Primary | Dose limiting toxicity (DLT) | Up to 28 days from the first dose | Dose escalation cohorts are monitored and assessed using the NCI Common Toxicity Criteria for Adverse Events, version 5.0. |
| Secondary | Objective Response Rate (ORR) | Through study completion, an average of 9 months. | The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1. |
| Secondary | Disease Control Rate (DCR) | Through study completion, an average of 9 months. | Defined as CR + PR + stable disease (SD) based on RECIST version 1.1. |
| Secondary | Duration of Objective Response (DOR) | Through study completion, an average of 9 months. | Duration of response for CR or PR based on RECIST version 1.1. |
| Secondary | Progression Free Survival (PFS) | From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | |
| Secondary | Overall Survival (OS) | From first study drug administration until the date of death from any cause, assessed up to 24 months | |
| Secondary | Area under the curve (AUC0-∞) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420 and/or nab-paclitaxel. |
| Secondary | Area under the curve (AUC0-t) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420 and/or nab-paclitaxel. |
| Secondary | Maximum observed concentration (Cmax) | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle is 28 days) | Blood samples will be collected at designated time points for pharmacokinetic analysis of TT-00420 and/or nab-paclitaxel. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04742959
GET https://conductscience.org/api/trials/v1/NCT04742959/registered