The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
This study is an open-label, multi-center Phase I/II clinical trial. Phase I includes the dose escalation (Stage Ia) and dose expansion (Stage Ib) phases; Phase II is an open-label, multi-center, single-arm basket study to evaluate the efficacy and safety of XNW29016 tablets in subjects with the target indications. This study consists of a screening period, a treatment period, and a follow-up period. Subjects who meet the eligibility criteria during the screening period will enter the treatment period and receive treatment with XNW29016 tablets until the study treatment is discontinued due to reasons such as disease progression or intolerable toxicity. Safety data (such as routine blood tests, routine biochemical tests, ECG, etc.) will be continuously collected during the study, and blood samples for PK (pharmacokinetics), PD (pharmacodynamics), etc. will also be collected. Efficacy evaluation will be based on different tumor types and collect different indicators. The efficacy evaluation will be conducted once every 8 weeks in the first 48 weeks from the start of the study treatment, and then once every 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
17 South Li, Panjiayuan, Chaoyang District, Beijing City.
Beijing, Beijing Municipality, China
RECRUITINGPh Ia/Ib: Overall safety profile including adverse events
* Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[5.0\]) * Incidence of Dose Limiting Toxicities
Time frame: Baseline up to approximately 2 years
Ph Ia/Ib: Recommended phase 2 doses (RP2D) of XNW29016
RP2D of XNW29016 as administered orally twice daily (BID), continuously in 28-day cycles, in subjects by safety data, pharmacokinetic data, pharmacodynamic data and efficacy data
Time frame: Approximately 12 months
Ph Ia/Ib: Pharmacokinetic Parameters
The area under the plasma concentration-time curve (AUC)
Time frame: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacokinetic Parameters
Maximum plasma concentration (Cmax)
Time frame: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacokinetic Parameters
Elimination half-life (t1/2)
Time frame: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacodynamic Parameters
The relative change of PAR with the baseline before and after administration
Time frame: The cycle 0 and first 28-day cycle of therapy
Overall Response Rate (ORR)
ORR was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline reviewed by the investigator.
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Time frame: Baseline up to approximately 2 years