Clinical trial · Interventional
A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors
A Phase 1b/2 Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Advanced Solid Tumors (TRIDENT-2)
NCT05071183CI-TRIAL-00075608terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to achieve and optimize a dose that could provide a positive benefit risk profile
Summary
Brief summary (as posted)
A Phase 1b/2 Study of Repotrectinib in Combination with Other Anticancer Therapies for the Treatment of Subjects with KRAS-Mutant Advanced Solid Tumors (TRIDENT-2)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| KRAS Mutation-Related Tumors | — | UNRESOLVED | — |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TPX-0005 | Drug | Repotrectinib | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPX-0005 + Trametinib
- description
- TPX-0005 + Trametinib Dose Escalation and Dose Expansion Dose escalation: KRAS G12D mutant advanced solid tumors. Dose expansion: KRAS G12D locally advanced or metastatic NSCLC
- interventionNames
- Drug: TPX-0005
- Drug: Trametinib
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities
- timeFrame
- From initial dose to end of first cycle of treatment, approximately 28 days
- description
- Number of participants with first cycle DLTs to determine Mean Tolderable Dose (MTD) and/or RP2D. A DLT is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications that meets the criteria defined in each subprotocol. The MTD is defined as the highest dose level of repotrectinib given in combination with other anticancer therapy observed to cause a DLT in fewer than 33% of the treated subjects in the first treatment cycle (i.e., Cycle 1).
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 (or as required by local regulation). * Histological or cytological confirmation of unresectable or metastatic solid tumor malignancy harboring a KRAS mutation. * No more than 3 prior standard treatments appropriate for tumor type and stage of disease. * ECOG performance status ≤ 1. * Existence of measurable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria). * Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible. * Adequate organ function. Exclusion Criteria: * Major surgery within four weeks of the start of treatment. * Previous other cancer requiring treatment within the previous two years. * Clinically significant cardiovascular disease. * Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \> 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG * Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity). * Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption. * Subjects being treated with or anticipating the need for treatment with strong CYP3A inhibitors or inducers.
References
Publications (0)
Data not yet available
No reference posted for this study.