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CompletedLast updated: 31 January 2024

ARCUS Breast/Gyne: This phase I trial is testing different chemotherapy and immunotherapy combinations in patients with advanced triple-negative breast cancer or ovarian cancerA Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast and Gynecologic Malignancies

Clinical summary

Summary

This is a dose escalation and expansion trial. The Dose Escalation phase will inform the Dose Expansion dose level for AB928 alone and in combination with IPI-549. Patients enrolled in the Dose Expansion phase will be assigned to received the recommended dose level of AB928 and/or IPI-549 in combination with standard PLD or NIP chemotherapy. Patients will be assigned to an Arm based on their tumour diagnosis.

Conditions

This trial is treating patients with triple negative breast cancer or ovarian cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

ARCUS Breast/Gyne

More information

Trial Identifiers

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Trial sponsor

Arcus Biosciences, Inc.

Scientific Title

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast and Gynecologic Malignancies

Eligibility

Inclusion

  • Female participants, 18 years or older
  • Measurable disease per radiographic evaluation
  • Performance status 0 or 1
  • Available archival tissue sample (within 2 years) or a fresh tumor biopsy may be required
  • Adequate organ, cardiac, and bone marrow function
  • Dose escalation

    • Participants with breast cancer:

      • Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines) with disease progression
      • No available alternative or curative therapy
      • Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
    • Participants with ovarian cancer:

      • Locally advanced or metastatic ovarian cancer with disease progression
      • No available alternative or curative therapy
      • Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
  • Dose expansion

    • Participants with breast cancer:

      • Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines)
      • Disease progression after no more than 3 prior lines of therapy
    • Participants with ovarian cancer:

      • Locally advanced or metastatic ovarian cancer that is platinum-resistant
      • Disease progression after no more than 3 prior lines of therapy

Exclusion

  • Received a live, attenuated vaccine within 4 weeks prior to first study treatment
  • Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy within 4 weeks prior first study treatment
  • Cancer other than the disease under study within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin cancers
  • Inability to swallow oral medications
  • Participant is breastfeeding, pregnant, or expects to become pregnant during the study
  • Active autoimmune disease or documented history of autoimmune disease within 2 years prior to first study treatment
  • History of peptic ulcer or stomach bleeding within 6 months prior to first study treatment
  • Use of drugs contraindicated by the protocol within 4 weeks prior to and during study treatment
  • Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
  • Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
  • HIV, Hepatitis B, and C test results negative prior to first study treatment
  • Major surgery within 4 weeks prior to first study treatment
  • Participants who have previously received maximum cumulative lifetime anthracycline dosage or baseline ejection fraction <50% (on heart echography)

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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