A Study Evaluating the Efficacy and Safety of AB928-Based TreatmentCombinations in Patients with Metastatic Colorectal Cancer

Phase 1

Conditions: Metastatic colorectal cancer
MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2020-005386-13-IT

Lead Sponsor: Arcus Biosciences Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 247

Inclusion Criteria

1.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this
protocol2.Male and female participants =18 years of age inclusive, at the time of
signing the informed consent
3.Ability to comply with the study protocol in the Investigator's judgment
4.Histologically confirmed metastatic colorectal adenocarcinoma
5.Measurable (at least one target lesion) disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation. Note: Inclusion Criterion 5 is not required for participants entering into the Safety Run-in Cohort.
6.Participants with measurable disease and accessible tumor will undergo a pre-treatment biopsy (unless an archived specimen is
available) and on-treatment fresh tumor biopsy. The biopsy must not put participants at undue risk and the procedure must not be more invasive
than a core biopsy as documented in the medical record by the Investigator. Fresh biopsy of a tumor lesion not previously irradiated should be obtained. Tumors progressing in a prior site of radiation may be considered after Sponsor consultation.
• Participants for biopsy should have at least two measurable lesions at
baseline: one for tissue sampling and one for radiographic response
assessment.
7.Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1.
8.Life expectancy =3 months as determined by the Investigator
9.Adequate hematologic and end-organ function defined by the following laboratory test results at screening:
a. Absolute neutrophil count =1.5 x 10^9/L (1500/µL) without granulocyte colony-stimulating factor support
b. White blood cell counts =2.5x 10^9/L (2500/µL)
c. Lymphocyte count =0.5 x 10^9/L (500/µL)
d. Platelet count =100 x 10^9/L (100,000/µL) without transfusion
e. Hemoglobin =90 g/L (9.0 g/dL)
Participants must not have been transfused within 2 weeks prior to screening to meet minimum platelet and hemoglobin parameters.
f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
=2.5 x upper limit of normal (ULN), with the following exception:
i. Participants with documented liver metastases: AST and ALT =5 x ULN
ii. Participants with documented liver or bone metastases: alkaline
phosphatase (ALP) =5 x ULN
g. ALP =5 x ULN
i. If ALP >5 × ULN, then gamma-glutamyl transpeptidase must be within normal limits
h. Total bilirubin =1.5 x ULN, with the following exception:
i. Participants with known Gilbert syndrome: serum bilirubin level =3 x
ULN
i. Albumin =25 g/L (2.5 g/dL)
j. Serum creatinine =1.5 x ULN or creatinine clearance =30 mL/min as
determined by Cockcroft-Gault equation (Cockcroft and Gault, 1976)
10.Negative human immunodeficiency virus (HIV) test at screening. Due
to safety concerns related to viral activation, development of a
secondary malignancy, as well as the potential for increased treatment
related toxicity, eligible participants must not have evidence of chronic
HIV infection at screening
11.Negative hepatitis B surface antigen (HBsAg) and core antibody
(HBcAb) tests, or positive total HBcAb test followed by a negative
hepatitis B virus (HBV) DNA test at screening. The HBV test will be
performed only for participants who have a positive total HBcAb test.
Due to safety concerns related to viral activation, development of a
secondary malignancy, as wel

Exclusion Criteria

approved agents, systemic radiotherapy, or investigational therapy,
within 4 weeks (or 5 half-lives) whichever is shorter prior to initiation of
study treatment. Prior focal radiotherapy must be completed at least 2
weeks prior to the initiation of study treatment
2.QTc =480 msec using Fredericia's QT correction formula (based on an
average of triplicate recordings)
3.Prior allogeneic stem cell or solid organ transplantation
4.Treatment with systemic immunostimulatory agents (including, but
not limited to, interferon and interleukin-2) within 4 weeks (or 5 halflives)
whichever is shorter prior to initiation of study treatment
5.Treatment with systemic immunosuppressive medication (including,
but not limited to, corticosteroids, cyclophosphamide, azathioprine,
methotrexate, thalidomide, and antitumor necrosis factor-a agents)
administered at >10 mg/day prednisone or equivalent within 2 weeks
prior to initiation of study treatment, or anticipation of need for systemic
immunosuppressant medication during study treatment, with the
following exceptions:
a. Participants who received low dose (=10 mg/day prednisone or
equivalent), systemic immunosuppressant medications or a one-time
pulse dose of systemic immunosuppressant medication (eg, 48 hours of
corticosteroids for a contrast allergy) are eligible for the study after
Medical Monitor approval has been obtained.
b. Participants who received mineralocorticoids (eg, fludrocortisone),
inhaled or intranasal corticosteroids for chronic obstructive pulmonary
disease or asthma, or low dose corticosteroids for orthostatic
hypotension or adrenal insufficiency are eligible for the study after
Medical Monitor approval has been obtained.
6.Treatment with a live, attenuated vaccine within 4 weeks prior to
initiation of study treatment, or anticipation of need for such a vaccine
during study treatment or within 5 months after the last dose of study
treatment
7.Current treatment with anti-viral therapy for HBV
8.Structurally unstable bone lesions suggesting impending fracture
9.Symptomatic, untreated, or actively progressing central nervous
system (CNS) metastases
Due to limited space, for Study Treatment-Specific Inclusion Criteria
please refer to relative section of the protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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