Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers

NCT05749549 | Active Not Recruiting Phase 1

• 1 other identifier: BR1733-101
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase I/IIa, multi-center, open-label study of BR1733 with a dose escalation part followed by a dose expansion part in adult subjects with advanced cancers. This treatment to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Conditions

Advanced Cancer; Follicular Lymphoma; Peripheral T Cell Lymphoma; Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT, Phase Ⅰ only)

  To assess adverse events as dose limiting toxicities as defined by the protocol.

  28 day cycle of therapy

• Objective Response Rate (ORR, Phase Ⅱa)

  The proportion of patients with a best response of at least partial remission (including partial remission and complete remission) using disease appropriate standardized response criteria.

  24 months

Secondary Outcomes (10)

• Halflife (T1/2) of BR1733 monotherapy

  28 day cycle of therapy

• Area under curve (AUC) of BR1733 monotherapy

  28 day cycle of therapy

• Maximum plasma concentration (Cmax) of BR1733 monotherapy

  28 day cycle of therapy

• Area under curve, steady state (AUCss) of BR1733 monotherapy

  28 day cycle of therapy

• Maximum plasma concentration, steady state (Cmax,ss) of BR1733 monotherapy

  28 day cycle of therapy

Study Arms (1)

BR1733

EXPERIMENTAL

25-1200 mg QD or BID

Drug: BR1733

Interventions

BR1733 DRUG

Subjects will receive oral administration of BR1733.

BR1733

Eligibility Criteria

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

You may qualify if:

• Sign informed consent voluntarily.
• Subjects with PTCL, DLBCL or advance solid tumors diagnosed by histology or cytology，whose disease progressed after standard treatment or have no standard treatment.
• ECOG≤2.
• Expected survival period ≥ 3 months.
• Adequate organ function reserve at baseline.

You may not qualify if:

• Subjects with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis;
• Subjects with a history of other primary malignancies within 5 years (except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor), subjects with other primary tumors who had no evidence of disease for 5 years or more and did not require treatment could participate in the study;
• Subjects with any severe uncontrolled disease such as liver disease such as cirrhosis, decompensated liver disease, kidney failure needs for hemodialysis or peritoneal dialysis, etc.
• Subjects with HIV disease or a positive HIV test; or active hepatitis.
• Subjects with organ transplantation (apart from keratoplasty) or allogeneic hematopoietic stem cell transplantation.
• Subjects with impaired or clinically significant cardiac cerebrovascular disease.
• Subjects known to be allergic to experimental drugs or similar compounds.
• Subjects known with psychotropic substance abuse, alcohol or drug abuse, or mental disorders.
• Any previous treatment with other EED inhibitors (e.g., MAK683, FTX-6058, etc.).
• Females who are pregnant or breastfeeding.

Sponsors & Collaborators

• Shanghai Blueray Biopharma Co., Ltd.: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, T-Cell, Peripheral; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, B-Cell

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 16, 2023
• First Posted: March 1, 2023
• Study Start: April 19, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CN (1)