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Protocol # 19-037

Status

Recruiting

Description

This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.

Condition

  • Small Cell Lung Cancer

Interventions

  • ABBV-011
  • Budigalimab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Number of Participants With Adverse Events
  • Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011
  • Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab
  • Number of Participants With Dose Limiting Toxicities (DLTs)
  • Mean Change from Baseline in Vital Signs
  • Incidence of Laboratory Abnormaities
  • Mean Change from Baseline in Electrocardiogram (ECG) Parameters

Secondary Outcome:

  • Maximum Serum Concentration (Cmax) of ABBV-011
  • Area Under the Serum Concentration-Time Curve (AUCinf) of ABBV-011
  • Area Under the Serum Concentration-Time Curve within a Dosing Interval (AUC0-t) of ABBV-011
  • Time to Maximum Serum Concentration (Tmax) of ABBV-011
  • Observed Serum Concentration at Trough (Ctrough) of ABBV-011
  • Apparent Terminal Half-Life (T1/2) of ABBV-011
  • Accumulation Ratio of ABBV-011
  • Serum Clearance (CL) of ABBV-011
  • Steady State Volume of Distribution (Vss) of ABBV-011
  • Incidence of Antidrug Antibodies (ADA) Against ABBV-011 or Budigalimab (ABBV-181)
  • Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Clinical Benefit Rate (CBR)
  • Duration of Response (DOR)
  • Duration of Clinical Benefit (DOCB)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)

Enrollment

233

Study Start Date

October 24, 2018

Eligibility

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

Sponsors

AbbVie

Source

AbbVie

Official title

A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer

Clinicaltrials.gov Identifier

NCT03639194

     

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.