Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Trial acronym
ARCUS Breast/Gyne
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 people with triple negative breast cancer or ovarian cancer
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
-
Dose expansion
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 (metastatic) or has grown into nearby parts of the body (locally advanced).
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 are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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
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