Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BR111 for Injection

    Drug

    BR111-101 for injection will be administered by intravenous drip, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation or withdrawal from the study. The dose of each administration will be calculated based on the weight measured prior to such administration. The dosing regimen (dosing frequency and interval) for subsequent study may be adjusted based on prior data. The intravenous drip should last for ≥ 90 min for the first dose and may be adjusted to ≥ 30 min for subsequent doses if the first dose is tolerable.

  • BR111 for Injection

    Drug

    BR111-101 for injection will be administered via intravenous drip at a fixed frequency and cycle until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study occurs. The dose for each administration will be calculated based on the body weight measured prior to administration. The dosing regimen (dosing frequency and interval) for subsequent studies may be adjusted based on prior data. The intravenous drip duration should be ≥ 90 minutes for the first dose and may be adjusted to ≥ 30 minutes for subsequent doses if the first dose is well tolerated.

Treatment groups

166 Participants
are divided into 1 treatment group
Group A: Does escalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD) of BR111 if any (for dose escalation part)

Participants will receive BR111 for injection once every three weeks. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT).

Time frame
About 9 months
2

Recommended Phase 2 Dose(RP2D) of BR111 (for dose escalation part)

The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range.

Time frame
About 9 months

Secondary outcomes

1

Incidence of anti-drug antibodies (ADA)

Time frame
Until 30 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
2

Incidence of Neutralizing antibodies (Nab)

Time frame
Until 30 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
3

Concentration of BR111 total antibody, prodrug and the free cytotoxin

Time frame
Until 30 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first
4

objective response rate（ORR）

Objective Response Rate is defined as the percentage of patients with a complete response (CR) or partial response (PR)

Time frame
Until 30 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioRay Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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