Search Cancer Clinical Trials

The Cancer Center offers patients access to a wide variety of clinical trials of promising new therapies. Use the search tool to find open protocols for your type of cancer.
Protocol # 21-398

Status

Recruiting

Description

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care. The study will last up to approximately 2 years.

Condition

  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplams
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms

Interventions

  • LY3537982
  • Abemaciclib
  • Erlotinib
  • Pembrolizumab
  • Temuterkib
  • LY3295668
  • Cetuximab
  • TNO155

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy
  • Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents

Secondary Outcome:

  • To assess preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Objective response rate (ORR)
  • To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Duration of Response (DOR)
  • To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Best Overall Response (BOR)
  • To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Time to response (TTR)
  • To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Disease control rate (DCR)
  • To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Progression-free survival (PFS)
  • To assess the preliminary antitumor activity of LY3537982 when administered alone or in combination with other investigational agents: Overall survival (OS)
  • To characterize the pharmacokinetics (PK) properties of LY3537982: Area under the plasma concentration versus time curve (AUC)
  • To characterize the PK properties of LY3537982: Maximum drug concentration (Cmax)

Enrollment

360

Study Start Date

July 19, 2021

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 1a/1b Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors

Clinicaltrials.gov Identifier

NCT04956640

     

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.