A Study of BRY805 in Participants With Advanced Solid Tumors

NCT06289894 | Terminated Phase 1

• 1 other identifier: BRY805-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of participants with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Occurrence of Drug Limited Toxicities (DLTs)

  To assess by the occurrence of Drug Limited Toxicities (DLTs)

  From Time of First dose through DLT observation period, 21 days

• Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

  To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

  From first dose until up to 91 days after the last dose

Secondary Outcomes (5)

• BRY805 Serum Concentrations

  From first dose to 31 days after the last dose

• Number of Participants with BRY805 Antibodies

  From first dose to 31 days after the last dose

• Overall Response Rate (ORR)

  Until study termination (approximately 2 years)

• Disease Control Rate (DCR)

  Until study termination (approximately 2 years

• Progression-Free Survival (PFS)

  Until study termination (approximately 2 years)

Study Arms (1)

BRY805

EXPERIMENTAL

Drug: BRY805 injection

Interventions

BRY805 injection DRUG

BRY805 will be administered via IV infusion every 3 weeks. , Six dose levels of 0.3, 1, 3, 9,18 and 30 mg/kg will be tested

BRY805

Eligibility Criteria

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

You may qualify if:

• \. Willing and able to provide signed informed and to comply with all study procedures; 2. Male or female ≥ 18 years; 3. Advanced malignant solid tumor patients who have experienced treatment failure using established therapeutic methods, have no viable standard treatment options available, or are unable to tolerate standard therapy; 4. ECOG score ≤ 1; 5. Life expectancy ≥ 3 months; 6. Considering that the phase I trial mainly evaluates the safety and tolerability of the drug, subjects who cannot measure the lesion can be enrolled in the dose escalation phase to obtain more safety, pharmacokinetic and pharmacodynamic results. Enrolled subjects who may have been expanded at 1-3 doses that may have been selected in the early period, have at least one measurable lesion in the baseline period according to RECIST v1.1; 7. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy except alopecia, \< Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy; 8. Sufficient organ and bone marrow function; 9. Female subjects of childbearing age must have a negative serum pregnancy test result when they enter this study (tested within 1 week before the first dose); Female subjects of childbearing potential or male subjects whose sexual partner is a female of childbearing age, who are willing to use appropriate and effective contraceptive measures such as abstinence and double barrier methods (such as condoms plus contraceptive diaphragms), oral contraceptives, intrauterine device insertion, etc., during the study period and within 6 months after the last dose.

You may not qualify if:

• \. Hypersensitivity to study drug or components of its formulation; or have had a severe allergic reaction to other monoclonal antibodies; 2. Prior treatment with NKG2A-targeted agents; 3. Participants will be excluded if they meet any of the following criteria:
• Major surgery within 4 weeks prior to the first dose, or anticipated major surgery during the study, minor surgery within 2 weeks prior to the first dose;
• Use of immunosuppressive medications within 2 weeks prior to the first dose; nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or equivalent pharmacophysiological doses of other corticosteroids) are allowed in the absence of active autoimmune disease;
• Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose; ④ Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose, or used therapeutic radiopharmaceuticals (strontium, samarium, etc.) within 8 weeks prior to the first dose; ⑤ Participation in other clinical trials within 4 weeks prior to the first dose.

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong Tumor hospital

Jinan, Shandong, 250117, China

Location

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: February 26, 2024
• First Posted: March 4, 2024
• Study Start: March 13, 2024
• Primary Completion: May 16, 2025
• Study Completion: July 4, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)