Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET… (NCT04161391) | Clinical Trial Compass
TerminatedPhase 1/2
Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations
Stopped: Adverse change in the risk/benefit.
United States41 participantsStarted 2019-12-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 (or age ≥ 20 as required by local regulation).
✓. Histological or cytological confirmation of advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations, who either have disease progression on, or are intolerant to standard therapy; OR are ineligible for standard therapy or for whom no standard therapy exists; OR are unlikely to tolerate or derive clinical benefit from standard therapy in the opinion of the Investigator OR have declined standard therapy.
✓. ECOG performance status ≤ 1.
✓. Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria).
✓. Subjects with asymptomatic primary CNS tumors or brain metastases are eligible for the study if they meet protocol specified criteria.
✓. Adequate organ function.
✓. Life expectancy ≥ 12 weeks.
Exclusion criteria
✕. Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
What they're measuring
1
Number of Participants With Dose Limiting Toxicities (DLTs) of TPX-0046
Timeframe: 28 days following the first highest dose of the dose regimen administered in Cycle 1
2
Maximum Tolerated Dose (MTD) of TPX-0046
Timeframe: 28 days following the first highest dose of the dose regimen administered in Cycle 1
✕. Presence or history of any other primary malignancy within 3 years other than a history of adequately treated basal or squamous cell carcinoma of the skin, or any adequately treated in situ carcinoma.
✕. Major surgery within four weeks of the start of therapy.
✕. Clinically significant cardiovascular disease (either active or within six months before enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of CTCAE version 5.0 grade ≥ 2.
✕. Any of the following cardiac criteria:
✕. Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
✕. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
✕. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.