Clinical trials

6

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)

The goal of this clinical trial is to learn if tinengotinib combined with darolutamide or enzalutamide works to treat participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen receptor pathway inhibitors (ARPIs). It will also learn about the safety of the combination therapy. The main questions it aims to answer are: 1. If participants with mCRPC can benefit from the combination therapy of tinengotinib plus one ARPI? 2. What medical problems do participants have when taking the combination therapy? Participants will take tinengotinib with darolutamide or enzalutamide to find the optimal dose and regimen of tinengotinib for the combination therapy in stage A. In stage B, participants will take preferred combination regimen of tinengotinib plus darolutamide/enzalutamide identified in stage A. In stage C, researchers will compare selected combination therapy versus standard treatment and/or monotherapy to see if the combination therapy works better.

Participants needed: 182
Trial details
Phase: Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: TransThera Sciences (Nanjing), Inc.Updated: Oct 13, 2026Locations: 16
Eligibility criteria

Male aged >= 18 years at the time of signing the informed consent form (ICF). [+9]

Prior treatment with tyrosine kinase inhibitors (TKIs). [+7]

Status: Not yet recruiting

A Phase II Study of TT-01488 Tablets in Combination With Anti-CD20 Monoclonal Antibody Therapy in Patients With Mantle Cell Lymphoma

This is a multicenter, open-label, phase II study evaluating TT-01488 in combination with different anti-CD20 monoclonal antibody-containing regimens for the treatment of treatment-naïve mantle cell lymphoma (MCL).

Participants needed: 188
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: TransThera Sciences (Nanjing), Inc.Updated: Oct 2, 2026Locations: 2
Eligibility criteria

Combination Cohort A: Part A (dose exploration): Age ≥18 years; no requirement f... [+9]

Participants whose treatment intent is tumor debulking prior to stem cell transp... [+10]

Status: Recruiting

Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment

The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are: 1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants? 2. What medical problems do participants have when taking the combination therapy? Participants will: Take tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A. In Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.

Participants needed: 94
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: TransThera Sciences (Nanjing), Inc.Updated: Mar 27, 2026Locations: 13
Eligibility criteria

Histologically or cytologically confirmed breast cancer with evidence of local r... [+10]

Participants who are pregnant or breastfeeding; [+16]

Status: Not yet recruiting

Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations

This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.

Participants needed: 138
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: TransThera Sciences (Nanjing), Inc.Updated: Jan 9, 2026Locations: 20
Eligibility criteria

≥ 18 years of age at the time of signing the informed consent form (ICF). [+7]

Subjects with a history of prior treatment with TT-00420 tablets. [+7]

Status: Available

Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors

This study is an open-label, multicenter study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors

Trial details
Biological sex: AllType: Expanded AccessSponsor: TransThera Sciences (Nanjing), Inc.Updated: Apr 17, 2024Locations: 5
Eligibility criteria

Subject is currently enrolled in a pre-defined TransThera-sponsored parent study... [+1]

Subject has been permanently discontinued from tinengotinib in the parent protoc... [+1]

Status: Recruiting

A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies

This is a multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.

Participants needed: 37
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: TransThera Sciences (Nanjing), Inc.Updated: Nov 21, 2023Locations: 1
Eligibility criteria

CLL/SLL treated with prior immunochemistry or BTK inhibitor containing regimen; [+10]

Women who are pregnant or lactating [+8]