このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

進行性固形腫瘍における腫瘍内N17350 (OP-NEU-101)

2026年10月16日 更新者：Onchilles Pharma Inc

進行性固形腫瘍患者におけるN17350の腫瘍内投与の安全性と有効性、および最適投与量の決定を調査する第1/2相オープンラベル、用量探索および拡張試験

The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies.

The main questions it aims to answer are:

  1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?
  2. Are there any side effects for participants when taking N17350?
  3. What is the safest dose of N17350 and the dose that should be used for further study?
  4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo.

Participants will:

  1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks
  2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects
  3. Have imaging scans (such as CT or MRI) to measure tumors and assess response
  4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a Phase 1/2 clinical study evaluating an investigational medicine called N17350 in adults with advanced solid tumors that have spread or cannot be removed by surgery and for which standard treatment options are no longer working, are not available, or are not appropriate.

N17350 will be administered by injection directly into tumor lesions (intratumoral injection). Giving N17350 into the tumor is intended to deliver treatment to the cancer site and may help stimulate an immune response against the tumor.

This is an open-label study, meaning all participants will receive N17350 and both participants and the study team will know the treatment being given. The study is designed to evaluate safety, identify an optimal dose, and look for early signs of anti-tumor activity.

Study Parts

The study includes two parts:

Part 1: Dose Finding (Phase 1) Small groups of participants will receive different dose levels of N17350. The main purpose is to understand how safe N17350 is and to determine a dose that can be given safely and is suitable for further study. Safety information from participants will be reviewed as dose levels are increased or adjusted.

Part 2: Dose Expansion (Phase 2) After a dose is selected from Part 1, additional participants will receive N17350 at that dose. This part is designed to better understand safety at the selected dose and to further evaluate how well N17350 may work in participants with advanced solid tumors. Depending on the study plan, expansion may include groups of participants with specific tumor types.

Treatment and Visits

Participants will receive N17350 injections into tumor lesions every second week for 8 or 12 weeks. Participants will attend clinic visits for treatment administration and ongoing monitoring.

Throughout the study, participants will undergo safety evaluations, which may include:

Review of side effects and other medical problems Physical examinations and vital signs Blood and urine tests Heart monitoring (such as ECG), if required Review of medications and overall health status

Participants will also undergo evaluations to measure how their cancer responds to treatment, which may include:

Imaging scans (such as CT or MRI) to measure tumors over time Clinical assessments of injected lesions and other tumor sites

Biomarker and Research Samples

The study may include collection of blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system. These samples may be used to study markers of immune activation and other biological changes that could be associated with response or side effects.

Outcomes and Goals

The main goals of the study are to:

Determine the type and frequency of side effects and evaluate overall safety

Identify a recommended dose and dosing approach for future studies

Evaluate early signs of treatment activity, such as tumor shrinkage, stable disease, or delayed tumor growth

Explore biological changes in blood and tumor tissue that may help explain how N17350 works

Study Hypothesis

The study hypothesis is that N17350 can be administered safely by intratumoral injection at doses that are tolerable, and that treatment may lead to anti-tumor effects in some participants with advanced solid tumors, potentially by helping the immune system recognize and attack cancer cells.

研究の種類

介入

入学 (推定)

275

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90095
        • 募集
        • UCLA - Jonsson Comprehensive Cancer Center
        • コンタクト：
      • Los Angeles、California、アメリカ、90025
        • まだ募集していません
        • The Angeles Clinic and Research Institute
        • コンタクト：
      • San Diego、California、アメリカ、92037
      • San Francisco、California、アメリカ、94143
        • まだ募集していません
        • University of California, San Francisco
        • コンタクト：
    • New York
      • Buffalo、New York、アメリカ、14263
        • 募集
        • Roswell Park Comprehensive Cancer Center
        • コンタクト：
    • Texas
      • Houston、Texas、アメリカ、77030
        • 募集
        • The University of Texas MD Anderson Cancer Center
        • コンタクト：
  • オーストラリア
    • New South Wales
      • Newcastle、New South Wales、オーストラリア、2298
      • Westmead、New South Wales、オーストラリア、2145
        • 募集
        • Westmead Hospital
        • コンタクト：
    • Victoria
      • Melbourne、Victoria、オーストラリア、3550
        • 募集
        • Peter MacCallum Cancer Centre (PMCC)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Age ≥18 years (or legal age of consent in the study jurisdiction).

  2. Able to provide written informed consent and willing/able to comply with study procedures, visits, and follow-up.

  3. Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.

  4. ECOG performance status 0-1.

  5. Measurable disease per IT-RECIST (Parts A1/A2) and RECIST v1.1 (Part A3), as applicable.

  6. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe/accessible for injection:

    1. Superficial lesions: ≥10 mm in longest diameter (or multiple lesions each ≥5 mm with aggregate longest diameter ≥10 mm), and ≤80 mm, accessible for direct injection (± ultrasound guidance).
    2. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection.
    3. Injected lesions must not involve/encase major blood vessels or otherwise pose an unacceptable bleeding/vascular risk, per investigator assessment and imaging review (as applicable).
    4. Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection.

  7. Adequate recovery from prior therapy: toxicities from prior anticancer treatment resolved to Grade ≤1 or baseline (except alopecia, controlled endocrine toxicities, or other stable toxicities as allowed per protocol/sponsor).

  8. Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds.

  9. Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds.

  10. Tumor tissue requirements: willingness to provide a pre-treatment tumor biopsy and on-study post-treatment biopsy, if an accessible lesion is available and safe for biopsy, and biopsy does not interfere with injection/response assessment; and/or availability of archival tumor tissue (obtained within 2 years prior to treatment), per protocol.

  11. Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy/fathering children from screening through 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose, per protocol.

Exclusion Criteria:

  1. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.

  2. History of solid organ transplant.

  3. Alpha-1 antitrypsin deficiency.

  4. Hereditary or acquired bleeding disorder/coagulation factor deficiency.

  5. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol).

  6. Baseline QTcF >480 ms.

  7. Pregnant or breastfeeding.

  8. Prior severe immune-mediated adverse event (imAE) from immunotherapy: ≥Grade 3 imAE within the past 16 weeks, any Grade 4 life-threatening imAE, or any neurologic/ocular AE of any grade (except controlled endocrine AEs on stable replacement therapy per protocol).

  9. Another active malignancy (current or within the past 2 years) other than the disease under study, except specified low-risk cancers treated with curative intent or under active surveillance (per protocol).

  10. Recent anticancer therapy: receipt of systemic anticancer therapy (including investigational agents) within 2 weeks prior to first dose (or 4 weeks for monoclonal antibodies/ADCs/other long half-life biologics), or within 5 half-lives, whichever is shorter.

  11. Recent radiotherapy within 2 weeks prior to first dose.

  12. Unresolved toxicity from prior anticancer therapy to >Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol).

  13. Uncontrolled or unstable brain metastases (eligible only if neurologically stable for ≥4 weeks, and off steroids or on stable/decreasing steroids ≤10 mg/day prednisone equivalent; carcinomatous meningitis excluded).

  14. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.

  15. Chronic viral infections not meeting protocol criteria:

    1. HBV with detectable DNA unless on appropriate antiviral therapy
    2. Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable)
    3. HIV infection with CD4+ count <300/μL, detectable viral load, or HIV-related illness within 6 months

  16. Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose.

  17. Chronic systemic corticosteroids >10 mg/day prednisone equivalent, or systemic immunosuppressive/anti-inflammatory medications within 4 weeks prior to first dose, except permitted topical/inhaled/local formulations or short courses for premedication per protocol.

  18. Known allergy/hypersensitivity to N17350 or any excipients.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：N17350 Intratumoral Injection 1 mg/ml superficial lesions

Participants with superficial lesions will receive 1 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection 2 mg/ml superficial lesions

Participants with superficial lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection 4 mg/ml superficial lesions

Participants with superficial lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection 2 mg/ml visceral lesions

Participants with visceral lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection 4 mg/ml visceral lesions

Participants with visceral lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection for cuSCC

Participants with cuSCC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection for Melanoma

Participants with Melanoma superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection for SCCHN

Participants with SCCHN superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection for NSCLC

Participants with NSCLC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
実験的：N17350 Intratumoral Injection for TNBC

Participants with TNBC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose.
生物学的：N17350

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events
時間枠：DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months

Safety and tolerability will be assessed by the incidence and severity of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and by laboratory abnormalities graded per CTCAE
DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months
Phase 2: Objective Response Rate (ORR) of lesions at RP2D/optimal dose(s)
時間枠：From baseline disease assessment until disease progression or initiation of a new anticancer therapy, assessed up to 15 months

ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) in superficial and/or visceral lesions, assessed in separate tumor-specific expansion cohorts at the selected optimal dose(s)/RP2D(s), per protocol-defined response criteria
From baseline disease assessment until disease progression or initiation of a new anticancer therapy, assessed up to 15 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) in lesions (Phase 1)
時間枠：From first dose through end of treatment (up to 12 weeks) and follow-up tumor assessments, assessed up to 12 months

ORR is defined as the proportion of participants with a best overall response of CR or PR in superficial and visceral lesions, assessed during dose escalation and backfill cohorts per RECIST v1.1 and/or IT-RECIST, as applicable
From first dose through end of treatment (up to 12 weeks) and follow-up tumor assessments, assessed up to 12 months
Systemic exposure (PK) of N17350 following intratumoral administration
時間枠：From first dose through 30 days after last dose, assessed up to 4 months.

Systemic exposure to N17350 will be assessed by serum concentrations of active and inactive N17350
From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
時間枠：From first dose through 30 days after last dose, assessed up to 4 months.

Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of Cmax
From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
時間枠：From first dose through 30 days after last dose, assessed up to 4 months.

Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of Tmax
From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
時間枠：From first dose through 30 days after last dose, assessed up to 4 months.

Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of area under the curve (AUC)
From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
時間枠：From first dose through 30 days after last dose, assessed up to 4 months.

Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of N17350 half life
From first dose through 30 days after last dose, assessed up to 4 months.
Immunogenicity of N17350 (anti-drug antibodies [ADA])
時間枠：From first dose through 30 days after last dose, assessed up to 4 months

Immunogenicity will be assessed by the incidence and titers of anti-drug antibodies (ADA) to N17350
From first dose through 30 days after last dose, assessed up to 4 months
Preliminary antitumor activity in lesions (ORR, DOR, DCR, CBR)
時間枠：From first dose until disease progression or start of new anticancer therapy, assessed up to 15 months

Antitumor activity in superficial and visceral lesions will be assessed by:

Objective Response Rate (ORR): proportion of participants with best overall response of CR or PR

Duration of Response (DOR): time from first documented response (CR or PR) to disease progression or death

Disease Control Rate (DCR): proportion of participants with best overall response of CR, PR, or SD

Clinical Benefit Rate (CBR): proportion of participants with CR, PR, or durable SD (as defined in the protocol)

Responses will be assessed per RECIST v1.1 and/or IT-RECIST, as applicable.
From first dose until disease progression or start of new anticancer therapy, assessed up to 15 months
Pharmacodynamic (PD) biomarkers
時間枠：From first dose through 30 days after last dose, assessed up to 4 months

Changes from baseline in PD biomarkers measured in blood and/or tumor samples, as applicable, following intratumoral administration of N17350
From first dose through 30 days after last dose, assessed up to 4 months
Progression-Free Survival (PFS) (Phase 2)
時間枠：From first dose until disease progression or death, assessed up to 15 months

PFS is defined as the time from first dose to disease progression or death from any cause, assessed per RECIST v1.1 and/or IT-RECIST, as applicable
From first dose until disease progression or death, assessed up to 15 months
Overall Survival (OS) (Phase 2)
時間枠：From first dose until death, assessed up to 15 months

OS is defined as the time from first dose to death from any cause.
From first dose until death, assessed up to 15 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Onchilles Pharma Inc

協力者

Onchilles Pharma Pty Ltd

捜査官

  • スタディディレクター：Emily Roberts-Thomson、Onchilles Pharma

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月25日

一次修了 (推定)

2028年7月1日

研究の完了 (推定)

2029年11月1日

試験登録日

最初に提出

2026年1月12日

QC基準を満たした最初の提出物

2026年1月12日

最初の投稿 (実際)

2026年1月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月21日

QC基準を満たした最後の更新が送信されました

2026年10月16日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • OP-NEU-101

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

An IPD sharing plan has not yet been finalized. Any decision to share individual participant data will be determined after study completion and will consider participant privacy, informed consent, and applicable regulations.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する