H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
NCT ID: NCT05552781
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
76 participants
INTERVENTIONAL
2022-08-26
2025-02-28
Brief Summary
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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).
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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20 mg QD, oral
H002 20mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
H002 capsule
Small molecule, Capsule
40 mg QD, oral
H002 40mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
H002 capsule
Small molecule, Capsule
80 mg QD, oral
H002 80mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
H002 capsule
Small molecule, Capsule
150 mg QD, ora
H002 150mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
H002 capsule
Small molecule, Capsule
250 mg QD, oral
H002 250mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
H002 capsule
Small molecule, Capsule
350 mg QD, oral
H002 350mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated.
H002 capsule
Small molecule, Capsule
Interventions
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H002 capsule
Small molecule, Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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R&G Pharma Studies Co.,Ltd.
INDUSTRY
RedCloud Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Zhen Tan
Role: STUDY_DIRECTOR
RedCloud Bio
Locations
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Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H002-101CN
Identifier Type: -
Identifier Source: org_study_id
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