A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT03093116
Trial Phases:	Phase I Phase II	Protocol IDs:	CA127-1024 (primary) NCI-2017-00648 CA127-1024 TPX-0005-01
Eligibility:	12 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Turning Point Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03093116

Summary

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs),
the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2
dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies
harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.

Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded
Independent Central Review (BICR) of repotrectinib in each subject population expansion
cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene
rearrangement. The secondary objective will include the duration of response (DOR), time
to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical
benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors
that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Objectives

In Phase 2, study subjects will be enrolled into 6 distinct expansion (EXP) cohorts:

- EXP-1: ROS1 TKI-naïve ROS1+ NSCLC. Up to one prior line of chemotherapy OR
immunotherapy is allowed

- EXP-2: 1 Prior ROS1 TKI AND 1 Platinum-based Chemotherapy ROS1+ NSCLC. Disease
progression, or intolerant to one prior line of a ROS1 TKI. Must have received one
prior line of platinum based chemotherapy OR one prior line of platinum based
chemotherapy in combination with immunotherapy before or after a ROS1 TKI

- EXP-3: 2 Prior ROS1 TKIs AND NO Chemotherapy ROS1+ NSCLC. Disease progression, or
intolerant to 2 prior lines of a ROS1 TKI treatment. No prior lines of chemotherapy
or immunotherapy are allowed.

- EXP-4: 1 Prior ROS1 TKI and NO Chemotherapy or Immunotherapy. Disease progression or
intolerant to one prior line of a ROS1 TKI. No prior lines of chemotherapy or
immunotherapy are allowed.

- EXP-5: TRK TKI-naïve NTRK+ solid tumors. Any number of prior lines of chemo or
immunotherapy is allowed.

- EXP-6: TRK TKI-pretreated NTRK+ solid tumors. Disease progression, or intolerant to
1 or 2 prior TRK TKIs. Any number of prior lines of chemo- or immunotherapy are
allowed.

Treatment Sites in Georgia

University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 800
Athens, GA 30607
www.universitycancer.com

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