A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients should understand, sign, and date the written informed consent form prior to screening.

• Male or female aged 18 years or older.

• Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC.

• Cohort-specific inclusion criteria:

∙ For the escalation part (except for the RDE confirmation part), patients have progressed on, rejected, or are intolerant of standard therapy, or for whom no standard therapy exists

‣ For RDE confirmation in the escalation part: same as Cohort 1 in the expansion part

‣ For the expansion part, patients have documented EGFR in-frame exon 20 insertion mutations confirmed by certificated local laboratories; and must also meet all criteria for the cohort in which their entry is proposed.

• Patients must have at least one measurable target lesion according to RECIST v1.1

• ECOG performance status 0 or 1

• 7\. Life expectancy ≥3 months

• Adequate organ function and bone marrow function.

• Electrolyte: magnesium within 0.85 to 1.25 × institutional normal limits, sodium ≥130 mmol/L, potassium within institutional normal limits

⁃ Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle1 Day1.

⁃ For patients participating in food effect exploration part:

• Be able to eat a standardized high-fat meal within 30 minutes

∙ Be able to fast for 10 hours.

⁃ Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study treatment and for approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.

Locations
United States
California
Precision NextGen Oncology
RECRUITING
Beverly Hills
Other Locations
China
Jilin Cancer Hospital
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Zhejiang Caner Hospital
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Anhui Chest Hospital
NOT_YET_RECRUITING
Hefei
Central Hospital Affiliated to Shangdong of First Medical University
NOT_YET_RECRUITING
Jinan
The first Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Shanghai Chest Hospital
RECRUITING
Shanghai
Union Hospital Tongji Medical College Huzhong University of Science and Techology
NOT_YET_RECRUITING
Wuhan
The first Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Yuan Lu
clinical@abbisko.cn
+86-21-68910052
Backup
Yinan Lin
yinan.lin@abbisk.com
+86-21-68910052
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2028-03
Participants
Target number of participants: 164
Treatments
Experimental: ABSK112
During the escalation part, the administration of oral ABSK112 will be guided by Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data.~A separate food effect cohort may be conducted.~In expansion part, patients will be treated at the selected RDE dose level.
Sponsors
Leads: Abbisko Therapeutics Co, Ltd

This content was sourced from clinicaltrials.gov

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