临床试验搜索器

联系方式

纳入标准

纳入标准

21 years and above of age
Estimated life expectancy of at least 12 weeks.
Has recovered from acute toxicities from prior anti-cancer therapies.
Has a tumor lesion that can be safely biopsied and who is willing to undergo tumor biopsy at baseline before starting study treatment

Phase Ib

Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry
There is no upper limit on the number of prior treatments provided all inclusion/

排除标准

exclusion criteria are met.
Prior treatment with immunotherapy is allowed.

Phase II

Patients with histologically or cytologically confirmed TNBC, defined by expression of estrogen (ER) and progesterone receptors (PR) of 10mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrolment. Inhaled or topical steroids, and adrenal replacement steroid >10mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Has received a live vaccine or live-attenuated vaccine within 30 days prior to first dose of study drug. Administration of killed vaccines is allowed.
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Active hepatitis B (defined as viral load ≥1000 copies/ml) or HCV (hepatitis C virus) [positive HCV RNA])

Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. Patients who are known HBV carriers on anti-viral therapy with a viral load of <1000 copies may be enrolled. HBV DNA must be obtained in these patients prior to enrolment.
Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Second primary malignancy that is clinically detectable at the time of consideration for study enrolment. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
History of significant neurological or mental disorder, including seizures or dementia.
History of allogenic tissue or solid organ transplant.
Unable to comply with study procedures.