Advanced Cancer Clinical Trial
Official title:
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
Verified date | February 2023 |
Source | Shanghai Blueray Biopharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 191 |
Est. completion date | May 2026 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai Blueray Biopharma Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicity (DLT, Phase ? only) | To assess adverse events as dose limiting toxicities as defined by the protocol. | 28 day cycle of therapy | |
Primary | Objective Response Rate (ORR, Phase ?a) | 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 | Halflife (T1/2) of BR1733 monotherapy | Pharmacokinetics profile of BR1733 (plasma): Halflife (T1/2) | 28 day cycle of therapy | |
Secondary | Area under curve (AUC) of BR1733 monotherapy | Pharmacokinetics profile of BR1733 (plasma): Area under curve (AUC) | 28 day cycle of therapy | |
Secondary | Maximum plasma concentration (Cmax) of BR1733 monotherapy | Pharmacokinetics profile of BR1733 (plasma): Maximum plasma concentration (Cmax) | 28 day cycle of therapy | |
Secondary | Area under curve, steady state (AUCss) of BR1733 monotherapy | Pharmacokinetics profile of continuous medication of BR1733 (plasma): Area under curve, steady state (AUCss) | 28 day cycle of therapy | |
Secondary | Maximum plasma concentration, steady state (Cmax,ss) of BR1733 monotherapy | Pharmacokinetics profile of continuous medication of BR1733 (plasma):
Maximum plasma concentration, steady state (Cmax,ss) |
28 day cycle of therapy | |
Secondary | Clearance/ bioavailability (CL/F) of BR1733 monotherapy | Pharmacokinetics profile of BR1733 (plasma): Clearance/bioavailability (CL/F) | 28 day cycle of therapy | |
Secondary | Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability | Adverse events assessed according to NCI-CTCAE v5.0 criteria. | Up to 2 years | |
Secondary | Duration of Response (DoR) | DoR is defined as the duration (days) from initial response to disease relapse, progression, or death due to any course. | Up to 2 years | |
Secondary | Overall Survival (OS) | OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor | Up to 2 years | |
Secondary | Progression-free survival (PFS) | PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first | Up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT01901237 -
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
|
N/A |