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Dose-Escalation and Dose-Expansion Study of ZX-4081 in Patients With Advanced Solid Tumors

Cancer Type
Breast Cancer
Colon/Rectal Cancer
Liver Cancer / Hepatoblastoma
Lung Cancer
Ovarian Cancer
Unknown Primary
Trial Phase
Phase I
18 Years and older, Male and Female
Study Type
Protocol IDs
ZX-4081 (primary)
Study Sponsor
Nanjing Zenshine Pharmaceuticals


A Phase 1, first-in-human, open-label, multicenter, dose escalation and dose expansion study
to investigate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor
activity of ZX-4081 administered orally (PO) twice daily (BID) in 28-day cycles in patients
with Advanced Solid Tumors.


  1. Metastatic or locally advanced solid tumor malignancies (breast cancer, urothelial cancer, ovarian cancer, melanoma, NSCLC, renal cell carcinoma, squamous cell cancer of the head and neck, colorectal cancer, and hepatocellular carcinoma) that has progressed on, is refractory to, intolerant to, or for which there is no curative standard of care therapy.
  2. Measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1.
  3. Demonstrate adequate organ function. All screening laboratories should be performed within 14 days of treatment initiation.
  4. Has a performance status of 0-2 on the ECOG Performance Scale.
  5. Life expectancy >12 weeks at baseline.
  6. Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Women of childbearing potential must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 120 days following last day study drug administration.
  7. Male patients of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 120 days following the last day of study drug administration.
  8. Age =18 years at screening.
  9. Able and willing to provide written informed consent and to follow study instructions.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.