A Study of BR111 in Patients With Advanced Malignancies
ConditionAdvanced Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioRay Pharmaceutical Co., Ltd.
About this trial
This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR111-101 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR111-101 for injection in patients with advanced malignancies.
Eligibility criteria
Qualifiers
Willingness to provide written informed consent for the study;
Age ≥ 18 years, male or female; Patients with solid tumors: Patients with histopathologically confirmed advanced solid tumors who are not amenable to surgical resection who have failed standard therapy (i.e., existing therapies with known clinical benefit) (disease progression during or after treatment) or who cannot tolerate standard therapy and are unable to obtain or refuse or have no standard therapy.
All patients are required to provide tumor samples for biomarker analysis at screening.
ECOG score 0 to 1 .
Disqualifiers
Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE 5.0, Grade ≤1 or baseline（except for alopecia, pigmentation, or other toxicities judged by the investigator to have no safety risk）；
Known history of allergy or delayed allergic reactions to BR111 for Injection and its components and considered severe by the investigator;
Prior use of eribulin, or the treatments or clinical trials based on eribulin , or prior use of drugs or clinical trials targeting ROR1;
Primary central nervous system malignancy or invasion of the central nervous system (Patients with CNS invasion may be considered for enrollment if they are untreated but asymptomatic, or with CNS metastases that have been radiologically documented to be progression-free for at least 4 weeks and require no treatment for at least 4 weeks). ;
Trial design
Treatments tested in this trial
- BR111 for Injection
- BR111 for Injection
Treatment groups
166 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov