Trials / Terminated
TerminatedNCT04161391
Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations
A Phase 1/2 Study of TPX-0046, A Novel Oral RET/SRC Inhibitor in Adult Subjects With Advanced/Metastatic Solid Tumors Harboring Oncogenic RET Fusions or Mutations
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Turning Point Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase 1/2, first-in-human, open-label study to determine the safety, tolerability, PK, and preliminary efficacy of the novel RET/SRC inhibitor TPX-0046 in adult subjects with advanced or metastatic solid tumors harboring RET mutations or alterations. The study consists of three portions: 1) Phase 1 Dose Escalation and Food Effect Sub-study, and 2) Phase 1 dose expansion and 3) Phase 2 efficacy evaluation.
Detailed description
Phase 1 Dose Escalation and Dose Expansion: To evaluate the overall safety profile, characterize the PK profiles and assess the preliminary efficacy of TPX-0046 in adults subjects with advanced solid tumors harboring oncogenic RET fusions or mutations. Food Effect Sub-Study: To determine the effect of food on PK of TPX-0046 in adult subjects with advanced or metastatic solid tumors harboring oncogenic RET fusions or mutations. Phase 2 Efficacy Evaluation: To determine the overall safety and anti-tumor efficacy of TPX-0046 in defined cohorts of subjects with advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations.
Conditions
- Non Small Cell Lung Cancer
- Medullary Thyroid Cancer
- RET Gene Mutation
- Metastatic Solid Tumor
- Advanced Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TPX-0046 | Oral TPX-0046 capsules |
Timeline
- Start date
- 2019-12-06
- Primary completion
- 2023-05-22
- Completion
- 2023-05-22
- First posted
- 2019-11-13
- Last updated
- 2024-06-13
- Results posted
- 2024-06-13
Locations
21 sites across 2 countries: United States, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04161391. Inclusion in this directory is not an endorsement.