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Protocol # 20-487

Status

Recruiting

Description

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 130 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

Condition

  • Cholangiocarcinoma
  • Chondrosarcoma
  • Glioma
  • Any Solid Tumor

Interventions

  • LY3410738

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Recommended Phase 2 dose (RP2D)

Secondary Outcome:

  • Objective Response Rate
  • Assess the safety and tolerability of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine.
  • To assess the preliminary anti-tumor activity of LY3410738 monotherapy and in combination with cisplatin plus gemcitabine
  • Characterize PK properties of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine.
  • To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma.

Enrollment

180

Study Start Date

October 16, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Eli Lilly and Company

Source

Eli Lilly and Company

Official title

A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Clinicaltrials.gov Identifier

NCT04521686

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.