This study is being done to learn more about a new drug called BG-89894 (previously known as SYH2039). Researchers want to see if the drug is safe, how well people can tolerate it, how it moves through the body, and whether it shows any early signs of helping to treat cancer. The information gathered may help guide how future studies are designed. The entire study is expected to last about four years. People who join the study may receive treatment for around six months and will be followed for about 12 months after their treatment ends. The study plans to enroll participants over a three-year period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Administered orally
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGColumbia University Irving Medical Center
New York, New York, United States
RECRUITINGNext Virginia
Fairfax, Virginia, United States
RECRUITINGBlacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
RECRUITINGCancer Research South Australia
Adelaide, South Australia, Australia
RECRUITINGSt Vincents Hospital
Fitzroy, Victoria, Australia
RECRUITINGLinear Clinical Research
Nedlands, Western Australia, Australia
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITING...and 10 more locations
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants experiencing adverse events and serious adverse events as determined per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0), including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Time frame: Approximately 1 month
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-89894
RDFE is defined as dose level(s) recommended for expansion that will be determined based on the MTD or MAD, taking into consideration the longterm tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available.
Time frame: Approximately 18 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
R2PD is defined as the dose level recommended for phase 2 that will be determined based on safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity, and other relevant data.
Time frame: Approximately 18 months
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Approximately 18 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Apparent volume of distribution (Vd/F) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-89894
Time frame: Twice in the first month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-89894
Time frame: Twice in the first month
Phase 1b: Minimum observed plasma concentration (Cmin) of BG-89894
Time frame: Approximately up to 6 months
Phase 1b: Accumulation Ratio (AR) of BG-89894
Time frame: Twice in the first month
Phase 1a: Overall response rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1.
Time frame: Approximately 18 months
Phase 1a and 1b: Duration of response (DOR)
DOR is defined as the time from the first determination of objective response that is confirmed until the first documentation of disease progression or death, whichever comes first as assessed according to RECIST v1.1 by the investigator.
Time frame: Approximately 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with the best overall response of confirmed CR, PR, or stable disease as assessed according to RECIST v1.1 by the investigator.
Time frame: Approximately 18 months
Phase 1b: Progression free survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Time frame: Approximately 18 months
Phase 1b: Number of particpants with AEs and SAEs
Number of participants experiencing adverse events and serious adverse events as determined per CTCAE v5.0, including findings from physical examinations, ECGs, and laboratory assessments as needed.
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Phase 1b: Plasma Concentrations
Time frame: Approximately up to 6 months