A Phase 1 Study to Evaluate the Safety and Tolerability of AB122 in Subjects with Advanced Solid Tumors
- Conditions
- Cancer - Oesophageal (gullet)Cancer - Malignant melanomaAdvanced Solid TumorsEndometrial cancerMerkel cell carcinomaCancer - Lung - Non small cellCancer - Head and neckCancer - KidneyCancer - BreastCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12617001641381
- Lead Sponsor
- Arcus Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 39
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method