Trial Title:
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation
NCT ID:
NCT05541822
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
c-MET
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABN401
Description:
Tablets
Route of Administration: Oral
Arm group label:
Cohort 1: ABN401
Summary:
ABN401-003 is a Phase 2 clinical study to assess efficacy, safety, tolerability and
pharmacokinetic profile of ABN401 in specific populations of advance solid tumors with
c-MET alterations as monotherapy.
Detailed description:
This study will start with one cohort. Two additional cohorts are under consideration and
the study will be a parallel cohort expansion study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female ≥ 18 years of age or designated age of majority according to the
regulatory authorities, whichever is higher.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS), 0 or 1.
3. Have a life expectancy of at least 3 months.
4. Diagnosis:
1. must have histologically or cytologically confirmed NSCLC, advanced, recurrent,
or metastatic,
2. For Cohort 1: MET exon 14 skipping suspected by local or central biomarker
assessment. [local testing is accepted for eligibility; all patients will have
confirmation by central laboratory, but this result is not necessary for
eligibility; local molecular pathology result will suffice]. This testing can
be from archival or fresh tissue sample and/or blood specimen; any sample, any
test positive subjects are eligible.
5. Treatment experience
a. Cohort 1: Anti-tumor treatment naïve subject upon refusal to receive 1st line
standard of care, or not tolerated to 1st line standard of care, or progressed after
standard of care with no greater than 2 prior treatment regimens (neoadjuvant,
adjuvant, and maintenance therapies do not qualify as separate treatment regimens).
6. At least one measurable lesion per response evaluation criteria in solid tumors
(RECIST) 1.1, with the exception of bone-only disease (i.e., non-measurable disease
per RECIST 1.1) with at least 1 radiological non-target lesion.
7. If not menopausal or surgically sterile, willing to practice at least one of the
following highly effective methods of birth control for at least a (partner's)
menstrual cycle before and for 3 months after study drug administration:
1. Barrier type devices (examples are condom, diaphragm, and contraceptive sponge)
used only in combination with a spermicide
2. Sexual intercourse with vasectomized male/sterilized female partner,
3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable, or
transdermal) for at least 3 consecutive months prior to investigational product
administration (when not clinically contraindicated as in breast, ovarian and
endometrial cancers),
4. Use of an intrauterine contraceptive device. Note: Abstinence, the rhythm
method, and/or contraception by the partner are not acceptable methods of birth
control
8. Resolution of prior-therapy-related AEs (including immune-related AEs but excluding
alopecia) to ≤ Grade 1 per CTCAE v 5.0, and no treatment for these AEs for at least
2 weeks prior to the time of enrollment. Alopecia, sensory neuropathy Grade ≤ 2, or
other Grade ≤ 2 AEs not constituting a safety risk based on investigator's judgment
are acceptable.
9. Adequate organ function as indicated by laboratory values.
10. Tissue and blood specimens
1. Willing to undergo a new biopsy or have available archival formalin-fixed,
paraffin-embedded tumor tissue specimen. The archival tissue must be:
- collected after progression from most recent prior systemic anti-cancer
treatment, OR
- tissue samples collected prior to previous lines of treatment,
2. ALL subjects must undergo blood sample for biomarker assessment.
11. Able and willing to comply with the protocol and the restrictions and assessments
therein.
Exclusion Criteria:
1. Previous severe hypersensitivity reaction to any component of study drug(s).
2. Prior therapy
a. Previous treatment with c-MET inhibitors or hepatocyte growth factor
(HGF)-targeting therapy.
3. Genetic analysis results:
a. Cohort 1: Existing genetic data from the patient's tumor tissue showing known
molecular alterations which would make them eligible for targeted therapies (e.g.,
EGFR mutations, ALK rearrangements, KRAS mutation, ROS1 translocation, BRAF
mutation, RET alteration, and NTRK fusion, etc.).
4. Chronic inflammatory liver condition. History or clinical evidence of any
significant liver or biliary pathology including cirrhosis, infectious disease,
inflammatory conditions, steatosis, or cholangitis (including ascending cholangitis,
primary sclerosing cholangitis, obstruction, perforation, fistula of biliary tract,
spasm of sphincter of Oddi, biliary cyst or biliary atresia).
5. Presence or history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis
6. Impairment of GI function or GI disease that may significantly alter the absorption
of ABN401 (e.g., ulcerative diseases, uncontrolled nausea, uncontrolled vomiting,
uncontrolled diarrhea, or malabsorption syndrome)
7. Prior organ or stem cell transplant.
8. Known active infection with human immunodeficiency virus (HIV), human T-cell
leukemia virus, type (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV),
unless the patients fall into below categories (patients fall into one of the a, b,
c category are eligible to participate)
a. HIV
- CD4+ cells ≥ 350 cells/µL
- No history of AIDS
- No history of opportunistic infection in the past 12 months b. HCV
- Undetectable viral load (Participants positive for hepatitis C antibody are
eligible only if polymerase chain reaction is negative for hepatitis C RNA) c.
HBV
- Concurrent HBV treatment and undetectable viral load (Participants with a past
or resolved hepatitis B infection defined as the presence of hepatitis B core
antibody [anti-HBc] and absence of hepatitis B surface antigen are eligible)
9. Symptomatic ascites or pleural effusion, unless clinically stable for at least two
weeks following treatment for these conditions (including therapeutic thoraco- or
paracentesis).
10. Known active central nervous system (CNS) primary tumor or metastases and/or
carcinomatous meningitis. Patients with previously treated brain metastases may
participate provided they are clinically stable for at least 4 weeks prior to first
dose of ABN401, have no evidence of new or enlarging brain metastases and are off
steroids for at least 15 days prior to first dose of ABN401.
11. Presence or history of a malignant disease other than disease to be treated in
current protocol that has been diagnosed and/or required therapy within the past 3
years. Exceptions to this exclusion include the following: completely resected basal
cell and squamous cell skin cancers, indolent malignancies that currently do not
require treatment, and completely resected carcinoma in situ of any type.
12. Active infection requiring therapy. However, subject with minor infections requiring
oral antibiotics, (e.g., urinary tract infection, Upper respiratory tract infection,
etc.) could be eligible based on investigator's judgement.
13. Use of systemic corticosteroids > 10 mg/day prednisone or equivalent within 30 days
or other immunosuppressive drugs within 30 days prior to first drug administration.
14. Patients receiving treatment with medications that meet one of the following
criteria and that cannot be discontinued at least 1 week prior to the start of
treatment with ABN401 and for the duration of the study
- Strong and moderate inhibitors/inducers of P-glycoprotein
- Strong and moderate inhibitors/inducers of CYP3A4
- Proton pump inhibitors (PPI)
15. Has received or will receive a live vaccine within 30 days prior to the first
administration of study medication. Seasonal flu vaccine that does not contain live
vaccine are permitted.
16. Received an investigational product or treated with an investigational device within
30 days prior to first ABN401 administration.
17. Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or
tyrosine kinase inhibitors within 2 weeks (4 weeks in case of thoracic radiotherapy
to lung fields) or 5 half-lives (whichever is longer) of the start of study
treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study
treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6
weeks of the start of study treatment; 7-day washout is permitted for palliative
radiation (i.e. limited field, ≤ 14-day course of radiotherapy) to non-CNS lesions.
18. History or clinical evidence of any surgical or medical condition which the
investigator judges as likely to interfere with the results of the study or pose an
additional risk in participating e.g., rapidly progressive or uncontrolled disease
involving a major organ system-vascular, cardiac, pulmonary, gastrointestinal,
gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an
immunodeficiency, or clinically significant active psychiatric or abuse disorders.
19. Is a regular user (including "recreational use") of any illicit drugs or had a
recent history (within the last year) of substance abuse (including alcohol).
20. Pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study.
21. Patients with a corrected QT interval (using Fridericia's correction formula) (QTcF)
of > 470 msec (females) and > 450 msec (males).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical Oncology
Address:
City:
Lake City
Zip:
32024-3456
Country:
United States
Status:
Recruiting
Contact:
Last name:
Waseemulla Khan
Phone:
386-755-1655
Email:
wkhan@cancercareofnorthflorida.com
Contact backup:
Last name:
Lilibeth Macias
Phone:
(386) 755-1655
Phone ext:
6200
Email:
LMacias@cancercareofnorthflorida.com
Facility:
Name:
Mid Florida Center
Address:
City:
Orange City
Zip:
32763-8316
Country:
United States
Status:
Recruiting
Contact:
Last name:
Santosh Nair
Phone:
386-538-3169
Email:
drsmnair@aorcorp.com
Contact backup:
Last name:
Kiran Penta
Phone:
(386) 538-3169
Email:
kiran@aorcorp.com
Facility:
Name:
The Henry Ford Cancer Institute
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4000
Country:
United States
Status:
Recruiting
Contact:
Last name:
Le Xiuning
Phone:
713-561-2486
Email:
XLe1@mdanderson.org
Contact backup:
Last name:
Patti Smithwick
Phone:
(713) 561-2486
Email:
pjsmithwick@mdanderson.org
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ji-Youn Han
Phone:
+82319201154
Email:
jymama@ncc.re.kr
Contact backup:
Last name:
Ji Won Yoo
Phone:
82-10-5620-5953
Email:
jiwonyoo@ncc.re.kr
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yong Won Choi
Phone:
82-31-219-4267
Email:
dreamliebe@hanmail.net
Contact backup:
Last name:
Yerim Jung
Phone:
82-10-2465-5345
Email:
114907@aumc.ac.kr
Facility:
Name:
Boramae Medical Center
Address:
City:
Dongjak
Zip:
07061
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin-Soo Kim
Phone:
82-2-870-3875
Email:
gistmd@gmail.com
Contact backup:
Last name:
Youahn Seo
Phone:
82-2-870-3875
Email:
uahn57@naver.com
Facility:
Name:
Severance Hospital
Address:
City:
Sinchon-dong
Zip:
03776
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hye Ryun Kim
Phone:
82-2-2228-8173
Email:
nobelg@yuhs.ac
Contact backup:
Last name:
Bo Hyun An
Phone:
82-2-2228-8173
Email:
scbha@yuhs.ac
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28645
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ki Hyeong Lee
Phone:
82-43-269-6015
Email:
kihlee@chungbuk.ac.kr
Contact backup:
Last name:
Inyoung Jeong
Phone:
82-10-5579-7261
Email:
jeonginyoung22@gmail.com
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Young Saing Kim
Phone:
+82-10-3475-2435
Email:
zoomboom@gilhospital.com
Contact backup:
Last name:
Hyerim Choi
Phone:
+82-10-9930-7579
Email:
jasmin993075@naver.com
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju-si
Zip:
52728
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Gyeong-won Lee
Phone:
+82-55-750-9454
Email:
brightree24@gmail.com
Contact backup:
Last name:
Soon Ha Kim
Phone:
82-10-9079-8069
Email:
soonha109@naver.com
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yu Jung Kim
Phone:
+82-31-787-7041
Email:
cong1005@gmail.com
Contact backup:
Last name:
Bora Yoon
Phone:
+82-10-2351-0197
Email:
purplegirl33@naver.com
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yoon Ji Choi
Phone:
82-2-920-6079
Email:
yj_choi@korea.ac.kr
Contact backup:
Last name:
Woo-seon Lim
Phone:
82-2-920-6079
Email:
happyseony@kumc.or.kr
Facility:
Name:
Kangbuk Samsung Hospital
Address:
City:
Seoul
Zip:
03181
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yun-Gyoo Lee
Phone:
82-2-2001-1859
Email:
yungyoolee@gmail.com
Contact backup:
Last name:
Nara Shin
Phone:
82-10-6788-3022
Email:
snr150604@daum.net
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Daeho Lee
Phone:
+82230103214
Email:
leedaeho@amc.seoul.kr
Contact backup:
Last name:
Hajin Lee
Phone:
82-10-4692-2292
Email:
a01046922292@gmail.com
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Se-hoon Lee
Phone:
+82234101132
Email:
sehoon.lee@samsung.com
Contact backup:
Last name:
SooJung Lee
Phone:
+82-10-8906-9965
Email:
sj62.lee@samsung.com
Facility:
Name:
The Catholic University of Korea, Seoul St Mary's Hospitals
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin-Hyoung Kang
Phone:
+82225613238
Email:
oncologykang@naver.com
Contact backup:
Last name:
Joo Yeon Kim
Phone:
82-10-3537-3359
Email:
jyn1023@naver.com
Facility:
Name:
The Catholic University of Korea St Vincents Hospital
Address:
City:
Suwon
Zip:
16248
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Byoung-Yong Shim
Phone:
+82-31-249-8455
Email:
shimby@catholic.ac.kr
Contact backup:
Last name:
Yunhwa Kim
Phone:
82-10- 2953- 5676
Email:
xxx1205xxx@naver.com
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
404
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Te-Chun Hsia
Phone:
+886 4-22065866
Email:
d1914@mail.cmuh.org.tw
Contact backup:
Last name:
Shu Yin Liao
Phone:
+886-972-723899
Email:
asd911102@yahoo.com.tw
Facility:
Name:
Chi Mei Hospital, Liouying
Address:
City:
Tainan City
Zip:
736
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Shang-Wen Chen
Phone:
+886 6-6226999
Phone ext:
73232
Email:
saintwin.chen@gmail.com
Contact backup:
Last name:
Olivia Chen
Phone:
+886-6-6226999
Phone ext:
73232
Email:
hospital77649@gmail.com
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chun-Hui Lee
Phone:
+886 972-401657
Phone ext:
3042
Email:
chunhui811012@gmail.com
Contact backup:
Last name:
Pei-Hsuan Lin
Phone:
+886-6-2353535
Phone ext:
3042
Email:
linpei1029@gmail.com
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chih-Hsin Yang
Phone:
+886 2-23123456
Phone ext:
67511
Email:
chihyang@ntu.edu.tw
Contact backup:
Last name:
Ya-Ying Bai
Phone:
+886-2-23123456
Phone ext:
67855
Email:
yaying0508@ntuh.gov.tw
Facility:
Name:
National Taiwan University Cancer Center (NTUCC)
Address:
City:
Taipei
Zip:
10052
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yang Chih-Hsin
Phone:
+886-2-23123456
Phone ext:
67855
Email:
chihyang@ntu.edu.tw
Contact backup:
Last name:
Ya-Ying Bai
Phone:
+886-2-23123456
Phone ext:
67855
Email:
yaying0508@ntuh.gov.tw
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yuh-Min Chen
Phone:
+886 2-28757865
Email:
ymchen@vghtpe.gov.tw
Contact backup:
Last name:
Yu-Ching Fang
Phone:
+886-2-28712121
Phone ext:
82872
Email:
fangyaixian0928@gmail.com
Start date:
January 17, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Abion Inc
Agency class:
Industry
Source:
Abion Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541822
