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

17 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

102

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Rekrytering
        • The University of Texas MD Anderson Cancer Center
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Rekrytering
        • Aichi Cancer Center Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Rekrytering
        • National Cancer Center Hospital East
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Rekrytering
        • Kindai University Hospital
    • Shizuoka
      • Nagaizumi-cho, Shizuoka, Japan, 411-8777
        • Rekrytering
        • Shizuoka Cancer Center
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 135-8550
        • Rekrytering
        • National Cancer Center Hospital
      • Koto-Ku, Tokyo, Japan, 135-8550
        • Rekrytering
        • The Cancer Institute Hospital of JFCR (Japanese Foundation for Cancer Research)

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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, who have experienced disease progression during or following their most recent systemic therapy or have discontinued the therapy due to unacceptable toxicity
  • 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
  • (Part B only) Patients with prior lorlatinib treatment who experienced serious lorlatinib-related toxicities, or who experienced toxicities considered inappropriate for study participation at the discretion of the Investigator

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: PartA: Dose Escalation Part of AQUA07 monotherapy
Dose escalation to determine RP2D/MTD as AQUA07
Läkemedel: AQUA07
AQUA07 administrated orally
Experimentell: PartB: Dose Escalation Part of AQUA07 combotherapty with Lorlatinib
Dose escalation to determine RP2D/MTD of AQUA07 in combination with lorlatinib
Läkemedel: Lorlatinib
Lorlatinib administerd orally

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adverse events [PartA,B]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum plasma concentration (Cmax) of AQUA07 [PartA,B]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chugai Pharmaceutical

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juli 2026

Primärt slutförande (Beräknad)

31 augusti 2030

Avslutad studie (Beräknad)

31 augusti 2030

Studieregistreringsdatum

Först inskickad

14 maj 2026

Först inskickad som uppfyllde QC-kriterierna

24 maj 2026

Första postat (Faktisk)

1 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AQA101CT

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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).

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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