A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
About this trial
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.
Eligibility criteria
Qualifiers
Subjects fully understand and voluntarily participate in this study and sign informed consent.
Is unresectable or metastatic.
Has a history of low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
For HR-positive participants, is documented refractory to endocrine therapy, defined as having progressed on at least 1 endocrine therapy and determined by the investigator that subject would no longer benefit from further treatment from endocrine therapy.
Disqualifiers
A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors.
Trial design
Treatments tested in this trial
- FDA022-BB05
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov