A Study of BR111 in Patients With Advanced Malignancies

NCT06937957 | Recruiting Phase 1

• 1 other identifier: BR111-101
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (2)

• 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).

  About 9 months

• 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.

  About 9 months

Secondary Outcomes (4)

• Incidence of anti-drug antibodies (ADA)

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

• Incidence of Neutralizing antibodies (Nab)

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

• Concentration of BR111 total antibody, prodrug and the free cytotoxin

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

• objective response rate（ORR）

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

Study Arms (1)

Does escalation

EXPERIMENTAL

Drug: BR111 for Injection

Interventions

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.

Does escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with lymphoma: Patients with histopathologically confirmed relapsed/refractory B-cell lymphoma who meet the 2016 WHO classification criteria and are indicated for treatment and currently have no other standard treatment as judged by the investigator.
• All patients are required to provide tumor samples for biomarker analysis at screening.
• ECOG score 0 to 1 .
• Life expectancy ≥ 3 months.
• Phase Ia dose Escalation: Patients with solid tumors or lymphoma have at least one evaluable lesion at baseline (ie, no measurable lesions) according to RECIST v1.1 or Lugano 2014 criteria; Phase Ia Safety Expansion and Phase Ib: Patients with at least 1 measurable lesion at baseline according to RECISTv1.1 and Lugano 2014 criteria. Lesions previously treated with radiotherapy or intervention should not be considered target lesions unless there is unequivocal progression.
• Adequate organ and bone marrow function ；
• Female patients of childbearing potential (defined as those who are not surgically sterile with hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as having amenorrhea ≥ 12 months) must have a negative pregnancy test at entry into this study and must be non-lactating; female patients of childbearing potential or male patients with sexual partners of childbearing potential are willing to use appropriate effective contraceptive measures such as abstinence and double-barrier methods (e.g., condom plus diaphragm), oral contraceptives, and placement of an intrauterine device during the study and for 6 months after the last investigational product.
• Able to understand trial requirements and willing and able to comply with trial and follow-up procedures.

You may not qualify if:

• 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). ;
• Patients with bacterial, viral, fungal, mycobacterial, parasitic or other infections within 14 days before the first dose and requiring intravenous infusion therapy (except for neoplastic fever);
• Patients with a history of (non-infectious) interstitial lung disease/pneumonia requiring steroid therapy, or current interstitial lung disease/non-infectious pneumonia, or suspected interstitial lung disease/non-infectious pneumonia that cannot be excluded by imaging at screening; radiation pneumonitis patients without clinical symptoms after 3 months of radiotherapy can be enrolled;
• Advanced malignant tumor complications resulting in quiescent dyspnea or current need for continuous oxygen therapy;
• Patients with moderate to severe lung diseases that have clinically significant impact on lung function, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, or previous pneumonectomy within 3 months before enrollment;
• Peripheral neuropathy of Grade ≥ 2 (refer to NCI CTCAE 5.0) ;
• Accompanied by severe cardiovascular and cerebrovascular diseases or other serious organic diseases, including but not limited to:
• Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA Class III-IV), myocardial infarction, severe arrhythmia (such as sustained ventricular tachycardia, ventricular fibrillation), congenital long QT syndrome, torsades de pointes, etc. within 6 months prior to the first dose;
• Left ventricular ejection fraction LVEF \< 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan;
• Mean corrected QT interval prolongation \> 470 ms in 3 consecutive ECGs during the screening period, and QT interval correction (QTcF) is performed using the F ridercia formula;
• Grade ≥3 hypertension that cannot be stably controlled (refer to NCI CTCAE 5.0);
• Known inherited or acquired bleeding disorders or significant coagulation abnormalities (e.g., disseminated intravascular coagulation (DIC), autoimmune anemia, etc.)

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Cancer

Shanghai, Pudong New Area, No. 4333, Kangxin Road, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Zhimin Shao, Doctoral Degree

CONTACT

13611709888; zhimingshao@fudan.edu.cn

Jian Zhang, Doctoral Degree

CONTACT

18017312991; Syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): October 9, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)