This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
The primary objective of this study is to evaluate the safety and tolerability of JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during Dose Escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Administered orally
Administered orally
Henry Ford Health System
Detroit, Michigan, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
A DLT is defined as an adverse event (AE) regardless of attribution unless clearly related to underlying disease or extraneous cause during the first 21 days of Cycle 1 (DLT observation period).
Time frame: First 21 days of Cycle 1
Dose Escalation phase: Number of participants with adverse events (AEs)
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Time frame: Up to 3 years
Dose Expansion phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1
Time frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Dose Expansion phase: Duration of Response (DOR)
DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to 3 years
Dose Escalation phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1
Time frame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Dose Escalation and Dose Expansion phase: Time to response (TTR)
TTR is defined as the interval of time between the date of first treatment to the first documented response (CR or PR) as determined by investigator assessment per RECIST v1.1
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGJilin Cancer Hospital
Changchun, Jilin, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGDose Escalation phase: Duration of Response (DOR)
DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including time to peak plasma concentration (tmax)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: Ctrough
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including pre-dose through concentration (Ctrough)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: Area under the curve (AUC)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including area under the plasma concentration versus time curve (AUC)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: half-life (t½)
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including half-life (t½)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: total body clearance
Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including total body clearance
Time frame: Up to 3 years
Dose Expansion phase: 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 per RECIST v1.1 or death which occurs first.
Time frame: Up to 3 years
Dose Expansion Phase 2a: Overall Survival (OS)
OS is defined as the length of time between the date of first treatment to the date of death
Time frame: Up to 3 years
Dose Expansion phase: Disease Control Rate (DCR)
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
Time frame: Up to 3 years
Dose Expansion phase: Number of participants with adverse events (AEs)
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0
Time frame: Up to 3 years