Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- GIC1: The participant must have ability to understand and willingness to provide
signed written informed consent prior to any study related assessments and procedures
and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides
would be acceptable).
- GIC2: Age ≥ 18 years at the time of signing the informed consent
- GIC3: Gender: Male or female (premenopausal and postmenopausal)
- GIC4: ECOG performance status Grade 0-2
- GIC5: Estimated life expectancy > 12 weeks at the start of investigational medicinal
product (IMP) treatment.
- GIC6: Adequate organ function, evidenced by the following laboratory results within 30
days of the start of IMP:
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the past 28 days
- Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL/min for
small molecules and >30 mL/min for monoclonal antibodies unless otherwise
specified in the Arm Specific Eligibility.
These cut-off values may be modified with supporting data for specific drug regimens.
- GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of
IMP treatment start in women of childbearing potential. Pregnancy testing does not
need to be pursued in patients who are judged as postmenopausal before enrollment, or
who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal
ligation. If male, they must agree to refrain from donating sperm during treatment.
- GIC8: Contraception: Women of childbearing potential and men must be willing to use
adequate contraception for the duration of protocol treatment. Additional information
regarding contraception for the specific treatment arm will be added to the drug arm
description. Adequate contraception is defined as one highly effective form (i.e.,
abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and
condom / occlusive cap with spermicidal foam / gel / film / cream / suppository).
- GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy,
including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not
considered a safety risk for the patient) and recovery from surgical procedures.
- GIC10: Participant compliance: Patients who are willing and able to comply with
scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Additional arm specific inclusion criteria as needed by drug arm regimen
Exclusion Criteria:
- GEC1: Wash out periods: No other anticancer therapy within the following periods:
- chemotherapy or investigational agents, 3 weeks
- mitomycin C and nitrosoureas, 6 weeks
- radiotherapy, 3 weeks
- targeted therapy, 2 weeks
- MAbs, ADCs, and immunotherapy, 3 weeks
- endocrine therapy, no washout needed
- GEC2: Concurrent therapy with other Investigational Products.
- GEC3: Prior history of drug/regimen hypersensitivity: History of infusion-related
reactions and/or hypersensitivity to IMP or excipients of the study drug/drugs which
led to permanent discontinuation of the treatment.
- GEC4: Uncontrolled intercurrent illness including (active infection, diabetes,
pulmonary embolism in the past 6 months, or psychiatric illness/social situations that
would limit compliance with study requirements).
- GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of
clinically significant cardiovascular disease such as unstable angina, congestive
heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac
arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula
(QTcF) length > 470 msec for men and women. The QTcF cut-off value may be modified
with supporting data for specific drug regimens.
- GEC6: CNS tumoral spread: Active uncontrolled/symptomatic central nervous system
cancer/spinal cord compression. Previously treated and clinically stable lesions, as
per Investigator's judgment, are permitted.
- GEC7: Liver disease: Patients with clinically significant history of liver disease,
including viral or other known hepatitis, current alcohol abuse, or cirrhosis.
- GEC8: Recent major surgery within 4 weeks prior to start IMP treatment
- GEC9: Pregnancy or breastfeeding
- GEC10: Individuals accommodated in an institution because of regulatory or legal
order; prisoners or participants who are legally institutionalized.
- GEC11: Other conditions, which in the opinion of the investigator, would compromise
the safety of the patient or the patient's ability to complete the study.
- Additional arm specific exclusion criteria as needed by drug arm regimen
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/15/2024. Questions regarding updates should be directed to the study team contact.