| Eligibility |
Inclusion Criteria:
1. Willing and able to provide written informed consent form (ICF) for the trial. Adult
patients = 18 years at the time of signing ICF.
2. Histologically or cytologically confirmed unresectable locally advanced or metastatic
solid tumors in patients who must have progressed on, be refractory to, or intolerant
to prior SOC.
3. At least one measurable lesion as defined per RECIST Version 1.1.
4. Be able to provide archived or fresh tumor tissue specimens.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy =12 weeks.
Exclusion Criteria:
1. Receiving anti-tumor therapy (systemic anti-tumor therapies, immunotherapy,
biotherapy, topic therapy, other investigational product, radiation therapy, or
surgery) within 4 weeks prior to the first dose of study treatment; receiving
anti-tumor small-molecule agents within 2 weeks or 5 half-lives (whichever is longer)
prior to the first dose of study treatment; receiving anti-tumor Chinese traditional
medication and herbal remedies within 2 weeks prior to the first dose of study
treatment.
2. Prior history of other malignancies within the previous 3 years, except for
noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer,
non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that
has been surgically cured.
3. Major surgery or significant traumatic injury within 4 weeks before the first dose of
study treatment or not fully recovered from surgery; or surgery planned during the
study.
4. Not recovered to baseline or CTCAE v5.0 = grade 1 AEs from prior anti-cancer therapy
except for alopecia, or asymptomatic and clinically not significant laboratory
abnormalities.
5. Grade 2 or greater peripheral neuropathy (PN) when signing ICF, or history of grade 3
neurotoxicity or PN, or history of treatment discontinuation due to neurotoxicity or
PN.
6. Active pneumonitis/interstitial lung disease (ILD), or history of radiotherapy to lung
field within 12 months before the first dose of study treatment, or current lung
disease with clinical symptoms(e.g., symptomatic chronic obstructive pulmonary disease
or dyspnea)
7. Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases or
leptomeningeal disease or carcinomatous meningitis requiring ongoing treatment for CNS
metastases, including surgery or radiation therapy or steroids (>10 mg/day of
prednisone or equivalent) and antiepileptic agents.
8. Uncontrolled ascites, pleural effusion or pericardial effusion, as determined by the
Investigator.
9. Active autoimmune disease, except vitiligo or cured childhood asthma/allergies that
requires no intervention after adulthood, autoimmune-mediated hypothyroidism treated
with stable doses of thyroid hormone replacement, or Type I diabetes treated with
stable doses of insulin can be excepted.
10. History of organ transplantation (i.e., stem cell or solid organ transplant).
11. Known history of human immunodeficiency virus (HIV) infection with the exception of
patients with CD4+ T cell (CD4+) counts =350 cells/µL, or have not had a history of
AIDS-defining opportunistic infections, or have not had a history of AIDS-defining
opportunistic infections within the past 12 months , or on established antiretroviral
therapy (ART) for more than four weeks and have an HIV viral load <400 copies/mL prior
to enrollment.
12. Active hepatitis B or hepatitis C infection, demonstrated by positive serology or
requiring treatment. Subjects who are anti-HBs/HBcAb (+) without detectable HBV-DNA or
are with undetectable HCV RNA are eligible. Subjects co-infected with hepatitis B and
hepatitis C should be excluded.
13. Any other serious underlying medical conditions, including but not limited to,
uncontrolled diabetes mellitus, active uncontrolled infection (e.g. tuberculosis),
active gastric ulcer, uncontrolled seizures, cerebrovascular incidents within 6 months
prior to study treatment, gastrointestinal bleeding within 3 months prior to study
treatment, severe signs and symptoms of coagulation and clotting disorders.
14. Receipt of live vaccines within 4 weeks prior to the first dose of the study drug.
15. Females who are pregnant or breastfeeding.
16. History of severe hypersensitivity or known to be allergic to protein drugs or
recombinant proteins or excipients in BB-1709 drug formulation.
17. Concurrent condition that in the investigator's opinion would interfere with
evaluation of the study drug or interpretation of subject safety or study results.
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