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Protocol # 17-494

Status

Recruiting

Description

This study is designed to evaluate safety and antitumor activity of U3-1402 in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, U3-1402 will be evaluated in participants with metastatic or unresectable NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy. In Dose Expansion, U3-1402 will be evaluated in participants with metastatic or unresectable NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without EGFR-activating mutations) with disease progression during/after systemic treatment for locally advanced or metastatic disease.

Condition

  • Non-Small Cell Lung Cancer (NSCLC)

Interventions

  • U3-1402 (FL-DP)
  • U3-1402 (CTM-1 Lyo-DP)
  • U3-1402 (CTM-3 Lyo-DP)

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose-limiting toxicities (DLTs) during dose escalation
  • Summary of adverse events during dose escalation
  • Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) Committee during dose expansion
  • Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)
  • Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)

Secondary Outcome:

  • Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
  • Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
  • Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
  • Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
  • Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
  • Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
  • Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
  • Overall response rate (ORR) during dose escalation
  • Disease control rate (DCR) during dose escalation
  • Duration of response (DOR) during dose escalation
  • Time to response (TTR) during dose escalation
  • Progression free survival (PFS) during dose escalation
  • Overall Survival (OS) during dose escalation
  • Summary of adverse events during dose expansion
  • Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
  • Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
  • Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]), from time 0 to Day 21 (AUC-21d), and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
  • Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
  • Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
  • Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
  • Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
  • Overall response rate (ORR) during dose expansion
  • Disease control rate (DCR) during dose expansion
  • Duration of response (DOR) during dose expansion
  • Time to response (TTR) during dose expansion
  • Progression free survival (PFS) during dose expansion
  • Overall survival (OS) during dose expansion
  • Percentage of participants who are anti-drug antibody (ADA)-positive (baseline and post-baseline) and Percentage of participants who have treatment-emergent ADA during dose expansion (Cohort 4)

Enrollment

264

Study Start Date

October 30, 2017

Eligibility

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

Sponsors

Daiichi Sankyo, Inc.

Source

Daiichi Sankyo, Inc.

Official title

A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer

Clinicaltrials.gov Identifier

NCT03260491

     

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.