Clinical Trials Search
Clinical Trial 20851
Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03893955
Phase: Phase I
Prinicipal Investigator: Heather Han
Study Title
A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects with Locally Advanced or Metastatic Solid Tumors
Summary
A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.
Objective
The primary objectives of this study are: Dose-Escalation Phase: To determine the recommended Phase 2 dose (RP2D) of ABBV-927 + ABBV-368 with and without budigalimab (ABBV-181). Dose-Expansion Phase: To determine the preliminary objective response rate (ORR; using Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) of combinations of ABBV-927 with ABBV-368, budigalimab (ABBV-181), and/or chemotherapy in selected tumor types.
Therapies
Medications
ABBV-181 (Budigalimab); ABBV-368 (); ABBV-927 (); Budigalimab (); Nab-paclitaxel (Abraxane); Paraplatin (carboplatin); carboplatin ()
Inclusion Criteria:
Exclusion Criteria:
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