None listed
Conditions
Brief summary
This research study is testing the safety and tolerability of a potential new drug called AB122 in subjects with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a pathologically confirmed solid 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 subject and treating physician. Study details A major purpose of this study is to find a safe dose range of AB122 that can be given to humans with cancer. To do this, multiple study cohorts will be enrolled and receive ascending doses of AB122. This means that if one dose has passed the safety and tolerability review, the next higher dose will be given to the subsequent patient cohort. The study will stop once the maximum tolerable dose is determined. In addition, the study will look at the amount of study drug in the blood to evaluate the way the body processes the study drug (pharmacokinetics) and the way the study drug affects the growth of tumours in cancer patients (pharmacodynamics). This research study will help us understand whether AB122, the study drug, can be safely given to patients with cancer.
Interventions
Study drug: AB122 solution for infusion.
This is a dose escalation study with up to 36 subjects testing safety, pharmacokinetics and pharmacodynamics.
The study will consist of two parts, Part 1 and Part 2.
In Part 1 three cohorts will be dosed 80, 240 and 720mg of AB122 respectively. Subjects will initially be assigned to the Q2W dosing schedule(every 2 weeks). The Q3W dosing schedule (every 3 weeks) will be considered if de-escalation is required.
Part 2 will confirm Pharacokinetic and Pha
Study drug: AB122 solution for infusion. This is a dose escalation study with up to 36 subjects testing safety, pharmacokinetics and pharmacodynamics. The study will consist of two parts, Part 1 and Part 2. In Part 1 three cohorts will be dosed 80, 240 and 720mg of AB122 respectively. Subjects will initially be assigned to the Q2W dosing schedule(every 2 weeks). The Q3W dosing schedule (every 3 weeks) will be considered if de-escalation is required. Part 2 will confirm Pharacokinetic and Pharmacodynamics from Part 1. Dosing will either occur every 2, 3 or 4 weeks (Q2W, Q3W or Q4W respectively) there by subjects will be administered 2 doses of study drug per cycle for the Q2W schedule and one dose of study drug per cycle for the Q3W and Q4W schedules. Cycles for Q2W and Q4W dosing are 28 days, and Q3W dosing Cycle is 21 days. 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.
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female adults (18 years or over) 2. Pathologically confirmed non-small-cell lung cancer, squamous cell carcinoma of the head and neck, renal cell carcinoma, breast cancer, colorectal cancer (CRC), prostate 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 subject and treating physician. 3. ECOG performance status of 0 or 1. 4. Must have at least 1 measurable lesion per RECIST. Subjects with prostate cancer who have bone-only lesions must have progression of 2 lesions or a new lesion and rising prostate-specific antigen levels. The measurable lesion must be outside of a radiation field if the subject received prior radiation. 5. Up to 5 lines of prior systemic therapies for advanced/recurrent and progressing disease (an unlimited number of prior hormonal therapies is allowed). 6. Adequate organ and marrow function.
Exclusion criteria
1. Prior treatment with an anti-PD-L1, anti-PD-1, anti-CTLA-4, or other immune checkpoint inhibitor or agonist as monotherapy or in combination. 2. Has had prior chemotherapy, targeted small-molecule therapy, or radiation therapy within 2 weeks prior to Day 1 or has not recovered from AEs due to a previously administered agent. 3. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration. 4. Use of any vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study therapy. 5. 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. Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study. 6. Any acute gastrointestinal symptoms (eg, nausea, vomiting, diarrhea, heartburn) at the time of screening or admission. 7. Underlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous (ie, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms, etc) or obscure the interpretation of toxicity determination or AEs or concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. 8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 9. 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 or breast. 10. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment
Outcome results
None listed