A Phase 1 Open Label Dose-Escalation and Expansion Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Solid Tumors
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) For Phase 1 dose escalation with ORIN1001 alone: advanced solid tumors for which no effective standard of care treatments are available. 2) For Phase 1 dose escalation with ORIN1001 in combination with Abraxane®: relapsed refractory metastatic breast cancer (TNBC, or ER+ HER2-) must have progressed through at least 2 lines of therapy and for whom there are no available therapies that confer a clinical benefit. 3) For Phase 2: with relapsed refractory metastatic breast cancer. 4) Life expectancy of more than 3 months.

You may not be eligible for this study if the following are true:

  • 1) Neutrophil count <1500 2) Prior radiotherapy and surgery within 2 weeks. 3) Prior treatment with investigational drugs within 4 weeks. 4) Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, within 6 months prior to the first dose of study drug.


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