NCT02716116Befejeződött1/2. fázis

A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer

A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 28.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. Non-Asian, non-White participants will take TAK-788 to determine the safety and tolerability of TAK-788 treatment.

Állapot (regiszter): Befejeződött
Fázis (regiszter): 1/2. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 324 (tényleges)
Első benyújtás: 2016. márc. 14.
Kezdés: 2016. jún. 16.
Elsődleges befejezés: 2026. szept. 29.
Fő szponzor: Takeda
Betegségek: Tüdőrák
NCT-szám: NCT02716116
EudraCT-szám: 2016-001271-68

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
Bevont résztvevők: 324
2016. jún. 16. és az elsődleges befejezés (2026. szept. 29.) között
62 helyszín, 10 országban
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Korábbi kezelés

Previously received TAK-788.
Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.
Received radiotherapy <=14 days prior to the first dose of TAK-788 or has not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose
Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of TAK-788.
Have undergone major surgery within 28 days prior to first dose of TAK-788. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.
Part 1 (dose escalation) and Expansion Cohorts 1 to 3 of Part 2 (expansion phase) only:
- Have symptomatic CNS metastases at screening or asymptomatic disease requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK-788.
- Part 3 (extension cohort) and Expansion Cohorts 4 to 7 of Part 2 (expansion phase) only:
- Have known active brain metastases (have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions). Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days before the first dose of TAK-788, and have no evidence of new or enlarging brain metastases.
Have prolonged QTcF interval, or being treated with medications known to be associated with the development of torsades de pointes.

Más betegség

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 participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
- Note: This exclusion criteria does not apply to Expansion Cohort 7.
Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
Have significant, uncontrolled, or active cardiovascular disease.
Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
Have an ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history.
Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
Have gastrointestinal illness or disorder that could affect oral absorption of TAK-788.
Have any condition or illness that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the safety of the drug.

Laborértékek

Received small-molecule anticancer therapy (including cytotoxic chemotherapy, and investigational agents, ≤ 14 days prior to first dose of TAK-788 (except for reversible EGFR TKIs [that is, erlotinib or gefitinib], which are allowed in the dose escalation and expansion cohorts up to 7 days prior to the first dose of TAK-788).
Female participants who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period.
- Note: Female participants who are lactating will be eligible if they discontinue breastfeeding.

A regiszterben nem jelölt feltételek

General Inclusion Criteria all cohorts: dose escalation, antidiarrhea prophylaxis, dose escalation combination, expansion, and extension:
Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC disease (Stage IIIB or IV) or other solid tumors. For all cohorts except Expansion Cohort 7, the locally advanced or metastatic disease is NSCLC. For Expansion Cohort 7, the locally advanced or metastatic disease is any solid tumor other than NSCLC.
Must have sufficient tumor tissue available for analysis.
Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1.
Male or female adult participants (aged 18 years or older, or as defined per local regulations).
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Minimum life expectancy of 3 months or more.
Adequate organ function at baseline.
Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected (Fridericia) (QTcF) of less than or equal to (≤ ) 450 millisecond (ms) in males or ≤ 470 ms in females.
Willingness and ability to comply with scheduled visits and study procedures.
- Part 1: Dose Escalation Cohort Specific Inclusion Criteria:
Refractory to standard available therapies.
- Part 2: Expansion Cohort 1 Specific Inclusion Criteria:
Have a documented EGFR in-frame exon 20 insertion by a local test.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
Prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician.
- Expansion Cohort 2 Specific Inclusion Criteria:
Have one of the following documented by a local test:
- A HER2 exon 20 insertion;
- An activating point mutation in HER2.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
With an EGFR exon 20 insertion: Prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician.
- Part 2: Expansion Cohort 3 Specific Inclusion Criteria:
Have one of the following documented by a local test:
- An EGFR exon 20 insertion;
- A HER2 exon 20 insertion;
- An activating point mutation in HER2.
Previously treated with one or more regimen of systemic therapy for locally advanced or metastatic disease.
For participants with an EGFR exon 20 insertion: prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician.
For participants with a HER2 exon 20 insertion or HER2 activating point mutation: prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.
Have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions.
Have at least one target (that is, measurable) intracranial CNS lesion (greater than or equal to [ ≥ ]10 millimeter [mm] in longest diameter by contrast enhanced magnetic resonance imaging [MRI]).
- Part 2: Expansion Cohort 4 Specific Inclusion Criteria:
Have one of the following documented by a local test: an activating mutation in EGFR including exon 19 deletions or exon 21 L858R substitution (with or without T790M), or an uncommon activating mutation other than exon 20 insertion including, but not limited to, G719X (where X is any other amino acid), S768I, L861Q, or L861R.
Treatment naive for locally advanced or metastatic disease or previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
- Part 2: Expansion Cohort 5 Specific Inclusion Criteria:
- NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed, without active CNS metastases.
Have a documented EGFR in-frame exon 20 insertion by a local test.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
Previously showed an objective response to an EGFR TKI, and subsequently progressed as assessed by the investigator or treating physician.
- Part 2: Expansion Cohort 6 Specific Inclusion Criteria:
- NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease, without active CNS metastases.
Have a documented EGFR in-frame exon 20 insertion by a local test.
No prior systemic treatment for locally advanced or metastatic disease.
- Part 2: Expansion Cohort 7 Specific Inclusion Criteria:
- Participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active, without active CNS metastases.
Have a solid tumor that is not NSCLC, including, but not limited to, bladder/urinary tract cancer, breast cancer, gastric/esophageal cancer, biliary tract cancer, and head and neck cancer.
Is refractory to standard therapy.
Have EGFR or HER2 mutations, documented by a local test.
- Part 3: Extension Cohort Specific Inclusion Criteria:
Have a documented EGFR in-frame exon 20 insertion by a local test and sufficient tumor tissue available for central analysis.
Must have received at least 1 prior line of therapy for locally advanced or metastatic disease and no more than 2 regimens of systemic anticancer chemotherapies for locally advanced or metastatic disease.
- Prior treatment with an EGFR TKI is allowed unless the participant had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (62)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Beijing Chest Hospital	Beijing	Kína	Ismeretlen állapot
Peking University Cancer Hospital/Beijing Cancer Hospital	Beijing	Kína	Ismeretlen állapot
The First Affiliated Hospital, Zhejiang University	Hangzhou	Kína	Ismeretlen állapot
Shanghai Pulmonary Hospital	Shanghai	Kína	Ismeretlen állapot
Hubei Cancer Hospital	Wuhan	Kína	Ismeretlen állapot
Helios Klinikum Emil von Behring	Berlin	Németország	Ismeretlen állapot
Thoraxklinik Heidelberg	Heidelberg	Németország	Ismeretlen állapot
Complejo Hospitalario Universitario A Coruña	A Coruña	Spanyolország	Ismeretlen állapot
Hospital Clinic de Barcelona	Barcelona	Spanyolország	Ismeretlen állapot
Hospital Universitari Vall d'Hebron	Barcelona	Spanyolország	Ismeretlen állapot
The Royal Marsden NHS Foundation Trust	London	Egyesült Királyság	Ismeretlen állapot
Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Europeo Di Oncologia	Milan	Olaszország	Ismeretlen állapot
Azienda Ospedaliero Universitaria di Parma	Parma	Olaszország	Ismeretlen állapot
National Cancer Center Hospital East	Kashiwa	Japán	Ismeretlen állapot
Kurume University Hospital	Kurume-shi	Japán	Ismeretlen állapot
Kindai University Hospital	Ōsaka-sayama	Japán	Ismeretlen állapot
Sendai Kousei Hospital	Sendai	Japán	Ismeretlen állapot
Seoul National University Bundang Hospital	Seongnam-si	Dél-Korea	Ismeretlen állapot
Severance hospital	Seoul	Dél-Korea	Ismeretlen állapot
Seoul National University Hospital	Seoul	Dél-Korea	Ismeretlen állapot
Asan Medical Center	Seoul	Dél-Korea	Ismeretlen állapot
In Situ Global Clinical Trials Network	Manati	Puerto Rico	Ismeretlen állapot
National Taiwan University Hospital Yunlin Branch	Douliu	Tajvan	Ismeretlen állapot
Taichung Veterans General Hospital	Taichung	Tajvan	Ismeretlen állapot
National Cheng Kung University Hospital	Tainan	Tajvan	Ismeretlen állapot
National Taiwan University Hospital	Taipei	Tajvan	Ismeretlen állapot
University Of Michigan Comprehensive Cancer Center	Ann Arbor	Egyesült Államok	Ismeretlen állapot
Winship Cancer Institute	Atlanta	Egyesült Államok	Ismeretlen állapot
University of Colorado Cancer Center	Aurora	Egyesült Államok	Ismeretlen állapot
Brookwood Medical Center	Birmingham	Egyesült Államok	Ismeretlen állapot
Massachusetts General Hospital	Boston	Egyesült Államok	Ismeretlen állapot
Beth Israel Deaconess Medical Center	Boston	Egyesült Államok	Ismeretlen állapot
Dana-Farber Cancer Institute	Boston	Egyesült Államok	Ismeretlen állapot
Carolinas Healthcare System	Charlotte	Egyesült Államok	Ismeretlen állapot
Levine Cancer Institute	Charlotte	Egyesült Államok	Ismeretlen állapot
University of Virginia Cancer Center	Charlottesville	Egyesült Államok	Ismeretlen állapot
The University of Chicago Medicine	Chicago	Egyesült Államok	Ismeretlen állapot
City of Hope Comprehensive Cancer Center - Duarte	Duarte	Egyesült Államok	Ismeretlen állapot
Virginia Cancer Specialists - Fairfax Office	Fairfax	Egyesült Államok	Ismeretlen állapot
Compassionate Cancer Care - Fountain Valley	Fountain Valley	Egyesült Államok	Ismeretlen állapot
Banner MD Anderson Cancer Center	Gilbert	Egyesült Államok	Ismeretlen állapot
Lumi Research	Houston	Egyesült Államok	Ismeretlen állapot
The University of Texas MD Anderson Cancer Center	Houston	Egyesült Államok	Ismeretlen állapot
Investigative Clinical Research - Indiana	Indianapolis	Egyesült Államok	Ismeretlen állapot
Thompson Oncology Group - Knoxville - Downtown	Knoxville	Egyesült Államok	Ismeretlen állapot
University of California San Diego Moores Cancer Center	La Jolla	Egyesült Államok	Ismeretlen állapot
Pacific Shores Medical Group-Long Beach Elm	Long Beach	Egyesült Államok	Ismeretlen állapot
Cancer and Blood Specialty Clinic	Los Alamitos	Egyesült Államok	Ismeretlen állapot
Atlantic Health - Morristown Medical Center	Morristown	Egyesült Államok	Ismeretlen állapot
SCRI - Tennessee Oncology - Nashville - Centennial	Nashville	Egyesült Államok	Ismeretlen állapot
University of Virginia Cancer Center	Nashville	Egyesült Államok	Ismeretlen állapot
Memorial Sloan-Kettering Cancer Center	New York	Egyesült Államok	Ismeretlen állapot
Hightower Clinical	Oklahoma City	Egyesült Államok	Ismeretlen állapot
University of California Irvine Health Chao Family Comprehensive Cancer Center	Orange	Egyesült Államok	Ismeretlen állapot
AdventHealth Orlando	Orlando	Egyesült Államok	Ismeretlen állapot
Stanford Cancer Center - Palo Alto	Palo Alto	Egyesült Államok	Ismeretlen állapot
Oregon Health and Science University	Portland	Egyesült Államok	Ismeretlen állapot
SLO Oncology and Hematology Health Center	San Luis Obispo	Egyesült Államok	Ismeretlen állapot
Swedish Cancer Institute	Seattle	Egyesült Államok	Ismeretlen állapot
Siteman Cancer Center - Washington University Medical Campus	St Louis	Egyesült Államok	Ismeretlen állapot
The Oncology Institute of Hope and Innovation - West Tucson	Tucson	Egyesült Államok	Ismeretlen állapot
The Oncology Institute of Hope and Innovation	Whittier	Egyesült Államok	Ismeretlen állapot

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