To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation
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|ClinicalTrials.gov Identifier: NCT04052971|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : May 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: ABN401- Escalation Phase Drug: ABN401- Expansion Phase||Phase 1 Phase 2|
First part of the study uses single patient cohorts at the initial dose levels, followed by a classic 3+3 design, with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a dose-limiting toxicity (DLT).
The second part of the study consists of expansion cohorts will enroll Non-Small Cell Lung Cancer Harboring patients with c-MET dysregulation.
Once the MTD and RP2D are selected in Phase 1, Phase 2 expansion cohorts may be initiated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1-2 Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Dose-Expansion in Patients With Non-Small Cell Lung Cancer Harboring c-MET Dysregulation|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Escalation phase
Route of Administration: Oral
The study will follow a single patient cohort approach for the first 3 regular dose levels followed by classic 3+3 design. The starting dose is 50mg QD.
Drug: ABN401- Escalation Phase
Dose administration: Escalation Phase The regular dose levels of ABN401 will range from 50 mg to 1800 mg QD daily for 21 days.
Experimental: Expansion phase
Route of Administration: Oral
Once the maximum tolerated dose (MTD) or highest escalation cohort has been reached, or notable efficacy has been observed at a given dose level, a decision as to Recommended Phase 2 dose (RP2D) will be determined. Up to 40 patients with Non-Small Cell Lung Cancer Harboring c-MET Dysregulation will be recruited.
Drug: ABN401- Expansion Phase
Dose administration: Expansion Phase The expansion phase of the study will use the dose and schedule determined to be most appropriate in the dose escalation portion of the study. This may be the MTD and/or the RP2D and will consist of cohorts of NSCLC patients with c-MET dysregulation.
Patients will receive ABN401 800 mg, administered orally once daily for 21 days until disease progression, unacceptable toxicity, or patient withdrawal.
- To evaluate the safety and tolerability of ABN401. [ Time Frame: Measurements at Baseline till the last day of Visit ]Safety and tolerability determined by abnormal clinical laboratory tests, vitals signs, physical exam, ECG parameters, Liver function tests
- To determine the objective response rate (ORR) to ABN401 according to RECIST 1.1 [ Time Frame: Up to 30 days ]Objective response rate (ORR) is defined as the proportion of patients who experience a complete response (CR) or partial response (PR) as measured by RECIST 1.1.
- To determine the systemic PK of ABN401. [ Time Frame: Dose Escalation Phase: Cycle 1- Day 1, Day 2, Day 5, Day 8, Day 15; Dose Expansion Phase: Cycle 1, Day -2, Day 1, Day 2, Day 8, Day 15 ]
- To determine preliminary estimate of ABN401 efficacy in patients with selected malignancies [ Time Frame: Screening and at every 6 weeks from C1D1 independent of cycle length ]Efficacy will be assessed by CT/MRI Scans of the chest, abdomen and pelvis (patients with lung, pancreatic and ovarian cancer, and if clinically indicated for patients with other malignancies)
- Evaluate the duration of response (DoR) to ABN401 according to RECIST 1.1 [ Time Frame: Up to 30 days ]Duration of response (DoR) is defined as the time period from documentation of disease response to disease progression.
- Assess the objective disease control rate (DCR) of ABN401 according to RECIST 1.1 [ Time Frame: Up to 30 days ]Disease advanced control rate (DCR) is defined as the proportion of patients who achieve CR, PR, and stable disease (SD) as measured per RECIST 1.1.
- Determine progression free survival (PFS) according to RECIST 1.1 [ Time Frame: Up to 30 days ]Progression-free survival (PFS) is defined as the time from first dose of study drug until disease progression or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052971
|Contact: Sangsuk Leeemail@example.com|
|Contact: Jeesun Kimfirstname.lastname@example.org|
|Australia, New South Wales|
|ST George Private Hospital||Recruiting|
|Kogarah, New South Wales, Australia, 2217|
|Contact: Paul De Souza, Dr +61295539588|
|Sydney Southwest Private Hospital||Recruiting|
|Liverpool, New South Wales, Australia, 2170|
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|Scientia Clinical Research||Recruiting|
|Randwick, New South Wales, Australia, 2031|
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|Australia, Western Australia|
|Linear Clinical Research||Recruiting|
|Perth, Western Australia, Australia, 6009|
|Contact: Michael Millward, Dr +61861510923|
|Korea, Republic of|
|National Cancer Centre||Recruiting|
|Goyang-si, Gyeonggi-Do, Korea, Republic of, 10408|
|Contact: Ji-Youn Han, Dr +82319201154|
|Yonsei University Health System, Severance||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Byoung Chul Cho, Dr +82222280880|
|Asan Medical Centre||Recruiting|
|Seoul, Korea, Republic of, 05505|
|Contact: Daeho Lee +82230103214|