Trial Title:
H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
NCT ID:
NCT05552781
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Dose-escalation and Expansion
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
H002 capsule
Description:
Small molecule, Capsule
Arm group label:
150 mg QD, ora
Arm group label:
20 mg QD, oral
Arm group label:
250 mg QD, oral
Arm group label:
350 mg QD, oral
Arm group label:
40 mg QD, oral
Arm group label:
80 mg QD, oral
Other name:
H002
Summary:
This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the
safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in
patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung
cancer (NSCLC).
The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and
Part B is dose expansion phase (i.e., Phase IIa).
Detailed description:
Part A (Dose Escalation Phase) Approximately 36 subjects will be enrolled, based on the
"3+3" design for dose escalation and safety evaluation requirements. The total number of
subjects will depend upon the number of dose escalations necessary.
Part B (Dose Expansion Phase) Up to 20 subjects will be enrolled in each expansion arm,
the total number of subjects will depend upon the number of dose expansions (expansions
may be at more than one dose depending upon emerging data).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males or females aged ≥ 18 years at time of signing informed consent form (ICF).
2. Histological or cytological confirmed diagnosis of unresectable locally advanced or
metastatic NSCLC.
3. Subjects must have NSCLC harboring one or more active EGFR mutations known to be
associated with EGFR-TKI sensitivity (including, but not limited to Del19 and
L858R).
- Part A: All subjects may provide tumor sample to central laboratory to analyze
the EGFR mutation status according to their own willingness;
- Part B: All subjects must provide tumor sample to central laboratory to analyze
the EGFR mutation status. And subjects must have NSCLC harboring EGFR C797S
mutation.
Note: Tumor sample can be either an archival sample or a sample obtained by
pretreatment biopsy prior to H002 treatment.
4. • Part A: Subjects have received the best treatment available as determined by the
physician and must have radiological documented disease progression on the last
treatment administered prior to enrolling in the study.
• Part B: Subjects have received at least one previous EGFR-TKI treatment and have
radiological documented disease progression on the previous continuous EGFR-TKI
treatment. In addition, subjects may have received other antitumor treatments and
must have radiological documented disease progression on the last treatment
administered prior to enrolling in the study.
5. Presence of at least one measurable lesion according to RECIST v1.1 per investigator
assessment.
6. ECOG performance status of 0-1.
7. Life expectancy ≥ 12 weeks.
8. Adequate hematologic and organ function per protocol.
9. Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must
use highly effective contraception per protocol throughout the study. WOCBP must
have a negative serum and/or urine pregnancy test result within 7 days prior to the
first dose of H002.
10. Signed ICF, and this must be obtained before the performance of any
protocol-specific procedures.
Exclusion Criteria:
1. Treatment with any of the following:
Prior treatment with an EGFR-TKI within 8 days or approximately 5 × t1/2 prior to
the first dose of H002, whichever is longer; Prior treatment with immunotherapy or
biotherapy within 4 weeks prior to the first dose of H002; Radiotherapy (palliative
radiotherapy is completed at least 2 weeks prior to the first dose of H002 can be
enrolled) within 4 weeks prior to the first dose of H002; Herbal therapy that has
anti-tumor effects within 2 weeks prior to the first dose of H002; Mitomycin and
nitrosourea within 6 weeks prior to the first dose of H002; Oral fluorouracil such
as tegafur and capecitabine within 2 weeks prior to the first dose of H002;
Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or
other anti-tumor drugs for the treatment of NSCLC within 4 weeks or approximately 5
× t1/2 prior to the first dose of H002, whichever is longer.
2. Subjects with EGFR exon 20 insertion mutations only.
3. Prior marketed and/or investigational treatment for EGFR C797S mutation (including,
but not limited to BTP-661411, TQB3804 and BLU-945).
4. Is currently participating and receiving investigational therapy or using an
investigational device, or has participated in a study of an investigational agent
and received study therapy or used an investigational device within 4 weeks or 5 ×
t1/2 of the investigational product, whichever is longer, prior to the first dose of
H002.
5. Is expected to require any other form of anti-tumor therapy while on study.
6. Unresolved toxicity greater than CTCAE v5.0 Grade 1 from prior anti-tumor therapy.
7. ≥ CTCAE v5.0 Grade 2 skin toxicity at screening.
8. Treatment with strong inhibitors and strong inducers of CYP3A4 within 2 weeks prior
to the first dose of H002, or anticipation of need for such drugs during study
treatment.
9. Uncontrollable pleural effusion, ascites, or pericardial effusion.
10. Subjects who have symptomatic brain metastases, meningeal metastasis or spinal cord
compression.
11. Subjects who have a chronic or active infection that required systemic treatment
within 2 weeks prior to the first dose of H002.
12. Subjects who have gastrointestinal disorders that will affect oral administration or
the investigator judges that the absorption of H002 will be interfered.
13. History of hypersensitivity to active or inactive excipients of H002 or drugs with a
similar chemical structure or class to H002.
14. Subjects who received a diagnosis of, and/or tested positive at screening for human
immunodeficiency virus (HIV).
15. Subjects with active hepatitis B.
16. Presence or history of malignancy other than NSCLC with the exception of some
certain early-stage cancers.
17. Subjects who have clinically significant cardiovascular diseases that occurred
within 6 months prior to the first dose of H002, include but not limited to QTc
interval ≥ 450 msec (male) or ≥ 470 msec (female).
18. Major surgery or significant traumatic injury occurring within 4 weeks prior to the
first dose of H002 or anticipation of need for a major surgery during the study.
19. Medical history of ILD.
20. Medical history of severe eye disease without recovery to CTCAE v5.0 Grade 0 or 1.
21. Severe gastrointestinal disease within 4 weeks prior to the first dose of H002 and
did not recover to ≤ CTCAE v5.0 Grade 2.
22. Has any bleeding tendency or coagulopathy within 6 months prior to the first dose of
H002.
23. Administration of a live, attenuated vaccine within 4 weeks prior to the first dose
of H002 or anticipation of need for such a vaccine during the study.
24. Female subjects in pregnancy or lactation.
25. Any other circumstances that would, in the investigator's judgment, prevent the
subject's participation in the clinical study due to safety concerns or compliance
with clinical study procedures.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Haerbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Yu, Doctor
Email:
gpyuyan@163.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingjun Li, Doctor
Email:
didilmj4505@sina.com
Contact backup:
Last name:
Qianqian Wang, Doctor
Email:
wangqqyfy@163.con
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaorong Dong, Doctor
Email:
xhzzdxr@126.com
Contact backup:
Last name:
Ruiguang Zhang, Doctor
Email:
zrg27@163.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Wu, Doctor
Email:
wulin-calf@vip.163.com
Contact backup:
Last name:
Jia Li, Doctor
Email:
lijia@hnca.org.cn
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
20030
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu, Doctor
Phone:
+86 21 2220-0000
Email:
Shun_lu@hotmail.com
Contact backup:
Last name:
Yongfeng Yu, Doctor
Phone:
+86 21 2220-0000
Email:
yuyongfeng212@sina.com
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongsheng Wang, Doctor
Email:
wangys@wchscu.cn
Contact backup:
Last name:
Yue Chen, Doctor
Email:
cy9209@163.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiping Zhang, Doctor
Email:
zhangyp@zjcc.org.cn
Contact backup:
Last name:
Zhengbo Song, Doctor
Email:
songzb@zjcc.org.cn
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianying Zhou, Doctor
Email:
drzjy@163.com
Contact backup:
Last name:
Junjun Chen, Doctor
Email:
chenjunjun1985@126.com
Start date:
August 26, 2022
Completion date:
February 28, 2025
Lead sponsor:
Agency:
RedCloud Bio
Agency class:
Industry
Collaborator:
Agency:
R&G Pharma Studies Co.,Ltd.
Agency class:
Industry
Source:
RedCloud Bio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05552781
