Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Turning Point Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TPX-0046Experimental Treatment1 Intervention

The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0046. The food-effect sub-study determines the effect of food on a dose of TPX-0046 at the RP2D dose level. The Phase 2 part of the study will determine the safety, tolerability, PK, and preliminary efficacy in specific cohorts. Phase 2 Cohorts: * Cohort I (NSCLC + RET fusion, RET TKI Therapy Naive) * Cohort II (NSCLC + RET fusion, RET TKI Therapy Pre-treated) * Cohort III (MTC + RET mutation, RET TKI Therapy Naive) * Cohort IV (MTC + RET mutation, RET TKI Therapy Pre-treated) * Cohort V (advanced/metastatic tumor with RET fusion or mutation, RET TKI Therapy Naive) * Cohort VI (advanced/metastatic tumor with RET fusion or mutation, RET TKI Therapy Pre-Treated)