A Phase 1/2a Multicenter Open-Label Non-Randomized First in Human Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of DB-1303 in Patients with Advanced/Metastatic Solid Tumors.

Are you eligible to participate in this study?

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

  • Conditions:
    Her2-positive Advanced Solid Tumor
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Female
  • Other Inclusion Criteria:
    1. Participant should have a pathologically documented HER2-positive or HER2-expressing advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. 2. At least 1 measurable lesion (per RECIST 1.1). 3. ECOG performance status (PS) of 0-1. 4. LVEF = 50% by ECHO or MUGA. 5. Adequate organ functions. 6. Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.

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

  • 1. History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment. 2. History of myocardial infarction or unstable angina within 6 months before Day 1. 3. Average QTcF > 450 ms in males and > 470 ms in females. 4. History of clinically significant lung diseases. 5. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 6. HIV infection with AIDS defining illness or active viral hepatitis. 7. Clinically active brain metastases.

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