This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies. The study consists of two parts: a dose escalation part and a dose expansion part.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent.
Ph 1: Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].
Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: through study completion, an average of 1 year
Ph 2: To evaluate the antitumor efficacy of XNW28012 at the recommended Part 2 dose.
ORR per RECIST1.1 assessed by Investigators.
Time frame: through study completion, an average of 1 year
Ph 1:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose.
To determine the maximum tolerated dose (MTD) and the recommended Part 2 dose with XNW28012;
Time frame: The first 21-day cycle of therapy
Ph 1/II: Maximum (peak) observed concentration (Cmax) of XNW28012.
Blood samples were collected at specified intervals for the determination of Cmax.
Time frame: through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of total antibody of XNW28012..
Blood samples were collected at specified intervals for the determination of Cmax.
Time frame: through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of YL0010014
Blood samples were collected at specified intervals for the determination of Cmax.
Time frame: through study completion, an average of 1 year
Ph 1/II: Anti-drug antibody (ADA)
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Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
RECRUITINGBeijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Provincial Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGAffiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGAffiliated Hospital of Hebei University
Baoding, Hebei, China
RECRUITINGAffiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITING...and 14 more locations
To assess the incidence of anti-drug antibody (ADA) against XNW28012
Time frame: through study completion, an average of 1 year
Ph I/II:Objective response rate (ORR)
ORR is defined as the proportion of subjects who have a confirmed CR or a PR per RECIST 1.1 assessed by Investigator.
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Disease control rate (DCR)
Rate of complete response \[CR\], partial response \[PR\], and stable disease per RECIST1.1 assessed by Investigator.
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II:Progression free survival (PFS)
Progression free survival (PFS) per RECIST1.1 assessed by Investigator
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Duration of response (DOR)
Duration of response (DOR) per RECIST1.1 assessed by Investigator.
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).