Last updated on May 2019

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


Brief description of study

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

Detailed Study Description

Dose escalation of the following will be assessed:

  • escalating doses of AB928 in combination with pegylated liposomal doxorubicin (PLD) at standard doses in participants with advanced metastatic triple-negative breast cancer or ovarian cancer;
  • escalating doses of IPI-549 in combination with the recommended phase 2 dose (RP2D) of AB928 and PLD in participants with advanced metastatic triple-negative breast cancer or ovarian cancer;
  • escalating doses of AB928 in combination with the nanoparticle albumin-bound-paclitaxel (NP) will also be assessed in participants with advanced metastatic triple-negative breast cancer.

Dose expansion of the following will be assessed:

  • AB928 in combination with PLD at standard doses will be assessed in participants with advanced metastatic triple-negative breast cancer or ovarian cancer. The dose of AB928 used will be determined based on the findings from the dose-escalation phase.
  • AB928 and IPI-549 in combination with PLD at standard doses will be assessed in participants with advanced metastatic triple-negative breast cancer. The dose of AB928 and IPI-549 used will be determined based on the findings from the dose-escalation phase.
  • AB928 in combination with NP at standard doses will be assessed in participants with advanced metastatic triple-negative breast cancer. The dose of AB928 and NP used will be determined based on the findings from the dose-escalation phase.

AB928 and IPI-549 are administered orally, and PLD and NP are both administered via iv infusion.

Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.

Clinical Study Identifier: NCT03719326

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Fairfax, VA

Fairfax, VA United States
5.27miles
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Recruitment Status: Open


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