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AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer

24. května 2026 aktualizováno: Chugai Pharmaceutical

A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as single agent and in combination with lorlatinib in patients with ALK positive non-small cell lung cancer.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

102

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form
  • Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.)
  • Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Ability and willingness to take oral medication(s)
  • Adequate organ function and bone marrow reserve

Exclusion Criteria:

  • Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy
  • Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy.
  • Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease
  • Significant cardiovascular disease
  • Inadequately controlled hypertension

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PartA: Dose Escalation Part of AQUA07 monotherapy
Dose escalation to determine RP2D/MTD as AQUA07
Lék: AQUA07
AQUA07 administrated orally
Experimentální: PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib
Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib
Lék: Lorlatinib
Lorlatinib administerd orally

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adverse events [PartA,B]
Časové okno: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months)
Incidence, nature and severity of adverse events
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 48 months)
Dose-Limiting Toxicities (DLTs) [PartA,B]
Časové okno: From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)
Incidence and nature of DLTs
From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)
Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and Recommendation Dose (RD) Determination [PartA,B]
Časové okno: From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)
Proportion of patients with course 1 DLT in each cohort
From cycle 0 day1 (if applicable) or cycle 1 day 1 to cycle 1 day 21 (each cycle is 21 days)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximum plasma concentration (Cmax) of AQUA07 [PartA,B]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the Cmax of AQUA07
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Average plasma concentration (Cavg) of AQUA07 [PartA,B]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the Cavg of AQUA07
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Time of maximum concentration (Tmax) of AQUA07 [PartA,B]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the Tmax of AQUA07
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Elimination half-life (t1/2) of AQUA07 [PartA,B]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the t1/2 of AQUA07
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Area under the plasma concentration-time curve (AUC) of AQUA07 [PartA,B]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the AUC of AQUA07
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Maximum plasma concentration (Cmax) of Lorlatinib [PartB] Maximum plasma concentration (Cmax) of Lorlatinib [PartB]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the Cmax of Lorlatinib
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Average plasma concentration (Cavg) of Lorlatinib [PartB]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the Cavg of Lorlatinib
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Time of maximum concentration (Tmax) of Lorlatinib [PartB]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the Tmax of Lorlatinib
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Elimination half-life (t1/2) of Lorlatinib [PartB]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the t1/2 of Lorlatinib
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Area under the plasma concentration-time curve (AUC) of Lorlatinib [PartB]
Časové okno: From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
To determine the AUC of Lorlatinib
From cycle 0 day 1 (if applicable) or cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Objective response related to preliminary clinical efficacy [PartA,B]
Časové okno: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Objective response, defined as a confirmed complete response (CR) or partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by the Investigator
From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Duration of response (DoR) related to preliminary clinical efficacy [PartA,B]
Časové okno: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
DoR is defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression per RECIST v1.1 as determined by the Investigator, or death from any cause, whichever occurs first
From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Disease control related to preliminary clinical efficacy [PartA,B]
Časové okno: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Disease control, defined as confirmed complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 as determined by the Investigator
From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Progression-Free Survival (PFS) related to preliminary clinical efficacy [PartA,B]
Časové okno: From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)
Progression-free survival (PFS), defined as the time from the first day of study treatment to the first occurrence of disease progression per RECIST v1.1 as determined by the Investigator, or death from any cause, whichever occurs first
From cycle 1 day 1 (each cycle is 21 days) until study completion or treatment discontinuation (up to approximately 48 months)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Chugai Pharmaceutical

Vyšetřovatelé

  • Ředitel studie: Sponsor Chugai Phamaceutical Co.Ltd, clinical-trials@chugai-pharm.co.jp

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

31. července 2026

Primární dokončení (Odhadovaný)

31. srpna 2030

Dokončení studie (Odhadovaný)

31. srpna 2030

Termíny zápisu do studia

První předloženo

14. května 2026

První předloženo, které splnilo kritéria kontroly kvality

24. května 2026

První zveřejněno (Aktuální)

1. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AQA101CT

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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