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A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies

NCT03719326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-05-24

No results posted yet for this study

Summary

This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.

Conditions

Interventions

DRUG

Etrumadenant

Etrumadenant is an A2aR and A2bR antagonist for oral use

DRUG

IPI-549

IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use

DRUG

Pegylated liposomal doxorubicin (PLD)

Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use

DRUG

nanoparticle albumin-bound paclitaxel (NP)

NP is a microtubule inhibitor for intravenous (IV) use

Sponsors & Collaborators

  • Infinity Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Arcus Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Arcus Biosciences, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2021-07-01
Completion
2021-07-02
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719326 on ClinicalTrials.gov