Trial Title:
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
NCT ID:
NCT06225804
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABSK112
Description:
In the escalation part, patients will receive a single dose of oral ABSK112 on Cycle1
Day1 only, and then patients will continuously receive ABSK112 once daily (QD) or twice
daily (BID) in subsequent cycles. In the expansion part, patients will each be treated at
the selected RDE dose level.
Arm group label:
ABSK112
Other name:
EGFR Exon20 inhibitor
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.
Detailed description:
The study will be started with a dose escalation part of ABSK112 administered in repeated
28-day cycles in patients with NSCLC. The expansion part of oral ABSK112 at the
recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability,
and preliminary antitumor activity among patients with locally advanced or metastatic
NSCLC harboring EGFR Exon20ins.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients should understand, sign, and date the written informed consent form prior
to screening.
2. Male or female aged 18 years or older.
3. Patients with histologically or cytologically confirmed locally advanced (and not a
candidate for definitive therapy) or metastatic NSCLC.
4. Cohort-specific inclusion criteria:
1. 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
2. For RDE confirmation in the escalation part: same as Cohort 1 in the expansion
part
3. 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.
5. Patients must have at least one measurable target lesion according to RECIST v1.1
6. ECOG performance status 0 or 1
7.
7. Life expectancy ≥3 months
8. Adequate organ function and bone marrow function.
9. Electrolyte: magnesium within 0.85 to 1.25 × institutional normal limits, sodium
≥130 mmol/L, potassium within institutional normal limits
10. 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.
11. For patients participating in food effect exploration part:
1. Be able to eat a standardized high-fat meal within 30 minutes
2. Be able to fast for 10 hours.
12. 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.
Exclusion Criteria:
1. Known allergy or hypersensitivity to any component of the investigational product.
2. NSCLC patients with EGFR Cys797Ser (C797S) mutation.
3. Cohort-specific exclusion criteria.
4. Have been diagnosed with another primary malignancy other than NSCLC except for
adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively
treated non-metastatic prostate cancer; or patients with another primary malignancy
who are definitively relapse-free with at least 3 years elapsed since the diagnosis
of the other primary malignancy.
5. Unable to swallow capsules or malabsorption syndrome, disease significantly
affecting GI function, or resection of the stomach or small bowel, symptomatic
inflammatory bowel disease or ulcerative colitis, or partial or complete bowel
obstruction, or current evidence of GI disease that present with diarrhea. If any of
these conditions exist, the sites' staff should discuss with the sponsor to
determine patient eligibility.
6. Previous anti-cancer therapy, including chemotherapy, radiotherapy, molecular
targeted therapy, antibody therapy or other investigational drugs received ≤4 weeks
prior to initiation of study treatment.
7. Major surgery within 4 weeks prior to the first dose of study drug. Or any surgical
wound is infected, dehisced, or not completely healed before the screening.
8. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies,
including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0)
with the exception of which eligibility criteria allows, or alopecia, vitiligo,
hypothyroidism stable on hormone replacement, or Grade 2 peripheral neurotoxicity.
Note: Refer to inclusion criteria regarding hypertension.
9. Potent moderate and strong inhibitors or inducers of CYP3A family within 2 weeks
before the first dose of study treatment (3 weeks for St John's Wort); consumption
of grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, seville
oranges or juice products within 3 days prior to the first dose of study treatment.
10. Have current spinal cord compression (symptomatic or asymptomatic and detected by
radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
11. Impaired cardiac function or clinically significant cardiac disease.
12. Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test
for HIV 1/2 antibody.
13. Exclusion of hepatitis infection based on the following results and/or criteria:
1. Active hepatitis B infection: positive tests for hepatitis B surface antigen
(HbsAg), or antibody to hepatitis B core antigen (anti-HBc). A patient with
positive tests for HbsAg or anti-HBc but with HBV-DNA measurements lower than
detectable can be enrolled.
2. Active hepatitis C infection: positive Hepatitis C virus antibody. If positive
antibody to hepatitis C Virus (anti-HCV) is detected, Hepatitis C virus RNA by
polymerase chain reaction (PCR) is necessary. A patient with positive anti-HCV
but with a negative test for HCV RNA can be enrolled.
14. Patients with ascites or pleural effusion, or pericardial effusion which is
refractory/uncontrolled, or requiring the intervention within 2 weeks prior to the
first dose.
15. Current evidence of radiation pneumonitis that required steroid treatment or
unresolved drug-related pneumonitis, or current evidence or history of interstitial
lung disease (ILD).
16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to
the start of study drug.
17. Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose
of study treatment except for administration of inactivate vaccines (e.g., COVID-19
vaccines, inactivated influenza vaccines).
18. Current evidence or previous history of corneal pathology such as keratopathy,
corneal abrasion or ulceration, or any other abnormal changes that may increase the
risk of corneal toxicity during the study treatment
19. Any other clinically significant comorbidities, such as uncontrolled pulmonary
disease, active infection, or any other condition, which in the judgment of
investigators, could compromise compliance with the protocol, interfere with the
interpretation of study results, or predispose the patient to safety risks.
20. Planned major surgery during study treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Precision NextGen Oncology
Address:
City:
Beverly Hills
Zip:
90212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kamlesh Sankhala, MD
Investigator:
Last name:
Kamlesh Sankhala, MD
Email:
Principal Investigator
Facility:
Name:
Anhui Chest Hospital
Address:
City:
Hefei
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rui Wang
Investigator:
Last name:
Rui Wang
Email:
Principal Investigator
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhiyong He
Investigator:
Last name:
Zhiyong He
Email:
Principal Investigator
Facility:
Name:
The first Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yu Yao
Investigator:
Last name:
Yu Yao
Email:
Principal Investigator
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Yu
Investigator:
Last name:
Yan Yu
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
qiming Wang
Investigator:
Last name:
qiming Wang
Email:
Principal Investigator
Facility:
Name:
Union Hospital Tongji Medical College Huzhong University of Science and Techology
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaorong Dong
Investigator:
Last name:
Xiaorong Dong
Email:
Principal Investigator
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lin Wu
Investigator:
Last name:
Lin Wu
Email:
Principal Investigator
Facility:
Name:
The first Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Longhua Sun
Investigator:
Last name:
Longhua Sun
Email:
Principal Investigator
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Cheng
Investigator:
Last name:
Ying Cheng
Email:
Principal Investigator
Facility:
Name:
Central Hospital Affiliated to Shangdong of First Medical University
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Meili Pan
Investigator:
Last name:
Meili Pan
Email:
Principal Investigator
Investigator:
Last name:
Qing Wen
Email:
Principal Investigator
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu
Investigator:
Last name:
Shun Lu
Email:
Principal Investigator
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenxiu Yao
Investigator:
Last name:
Wenxiu Yao
Email:
Principal Investigator
Facility:
Name:
Zhejiang Caner Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhengbo Song
Investigator:
Last name:
Zhengbo Song
Email:
Principal Investigator
Start date:
February 22, 2024
Completion date:
March 2028
Lead sponsor:
Agency:
Abbisko Therapeutics Co, Ltd
Agency class:
Industry
Source:
Abbisko Therapeutics Co, Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06225804
