Clinical trial · Interventional
Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers
A Multicenter, Open-Label Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics and Efficacy of BR1733 Monotherapy in Subjects With Advanced Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BR1733 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BR1733
- description
- 25-1200 mg QD or BID
- interventionNames
- Drug: BR1733
Primary outcomes (2)
- measure
- Dose Limiting Toxicity (DLT, Phase Ⅰ only)
- timeFrame
- 28 day cycle of therapy
- description
- To assess adverse events as dose limiting toxicities as defined by the protocol.
- measure
- Objective Response Rate (ORR, Phase Ⅱa)
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign informed consent voluntarily. 2. Subjects with PTCL, DLBCL or advance solid tumors diagnosed by histology or cytology，whose disease progressed after standard treatment or have no standard treatment. 3. ECOG≤2. 4. Expected survival period ≥ 3 months. 5. Adequate organ function reserve at baseline. Exclusion Criteria: 1. Subjects with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; 2. 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; 3. 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. 4. Subjects with HIV disease or a positive HIV test; or active hepatitis. 5. Subjects with organ transplantation (apart from keratoplasty) or allogeneic hematopoietic stem cell transplantation. 6. Subjects with impaired or clinically significant cardiac cerebrovascular disease. 7. Subjects known to be allergic to experimental drugs or similar compounds. 8. Subjects known with psychotropic substance abuse, alcohol or drug abuse, or mental disorders. 9. Any previous treatment with other EED inhibitors (e.g., MAK683, FTX-6058, etc.). 10. Females who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available