This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of AB154 as monotherapy and in combination with AB122 in participants with advanced solid malignancies.
This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety,
tolerability, PK, PD, and clinical activity of AB154 as monotherapy and in combination with
AB122 in participants with advanced solid malignancies. In this dose escalation study,
participants will receive AB154 administered intravenously as monotherapy or in combination
with AB122. Treatment will continue until progressive disease, unacceptable toxicity,
withdrawal of consent, or other reasons for study drug discontinuation occurs.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | August 21, 2018 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Primary Outcome 1 - Time Frame: From First Dose Date to 6 Months After Last Dose
Criteria:
Inclusion Criteria:
1. Capable of giving signed informed consent
2. Male or female participants ≥ 18 years of age at the time of screening
3. Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1;
negative serum or urine pregnancy test on the first day of each subsequent treatment
period
4. Pathologically confirmed non-small cell lung cancer, squamous cell carcinoma of the
head and neck, renal cell carcinoma, breast cancer, colorectal cancer, melanoma,
bladder cancer, ovarian cancer, endometrial cancer, Merkel cell carcinoma, or
gastroesophageal cancer that is metastatic, advanced, or recurrent with progression
for which no alternative or curative therapy exists or standard therapy is not
considered appropriate by the participant and treating physician
5. Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if
the participant received prior radiation
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
7. Must have received standard of care, including potentially curative available
therapies or interventions
8. Confirmation that an archival tissue sample is available and ≤ 6 months old; if not, a
new biopsy of a tumor must be obtained
9. Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given
to control the cancer) or biologic agents must have been completed at least 4 weeks
before investigational product administration, and all AEs have either returned to
baseline or stabilized
10. Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed
topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be
discontinued at least 2 weeks (14 days) before investigational product administration.
Physiologic doses of corticosteroids < 10 mg/day of prednisone or its equivalent may
be permitted
11. Prior surgery that required general anesthesia or other major surgery as defined by
the Investigator must be completed at least 4 weeks before investigational product
administration
12. Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or
hepatitis C qualitative ribonucleic acid [RNA; qualitative]), and human
immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
13. Adequate organ and marrow function
Exclusion Criteria:
1. Use of any live vaccines against infectious diseases (eg, influenza, varicella) within
4 weeks (28 days) of initiation of investigational product
2. Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will
make the administration of investigational product hazardous (eg, interstitial lung
disease, active infections requiring antibiotics, recent hospitalization with
unresolved symptoms)
3. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial
4. Any active autoimmune disease or a documented history of autoimmune disease or history
of a syndrome that required systemic steroids or immunosuppressive medications, except
for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require
intermittent use of bronchodilators (such as albuterol) will not be excluded from this
study
5. Prior malignancy active within the previous year except for locally curable cancers
that have been apparently cured, such as basal or squamous cell skin cancer,
superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate
cancer
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Medical Director
Role: Study Director
Affiliation: Arcus Biosciences, Inc.
Name: Medical Director
Phone: 510-694-6200
Email: ClinicalTrialInquiry@arcusbio.com
