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A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors (Luca-1)

2026年7月10日 更新者：SHY Therapeutics

A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors

This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).

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, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).

研究の種類

介入

入学 (推定)

30

段階

  • 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

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Colorado
      • Denver、Colorado、アメリカ、80218
        • まだ募集していません
        • SCRI at HCA HealthONE
        • 主任研究者：
          • Gerald Falchook, MD
    • Texas
      • Houston、Texas、アメリカ、77030
        • まだ募集していません
        • The University of Texas MD Anderson Cancer Center
        • 主任研究者：
          • Timothy Yap, MBBS, PhD
      • San Antonio、Texas、アメリカ、78229
        • 募集
        • NEXT Oncology
        • 主任研究者：
          • Ildefonso Rodriguez Rivera, MD

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Male or female ≥18 years of age.
  • Life expectancy >3 months.
  • ECOG performance status 0-1.
  • Histologically/cytologically confirmed advanced or metastatic solid tumors that have progressed on or are intolerant/unsuitable for standard therapies. Eligible tumor types: TNBC, HR+ breast cancer, colon cancer, gastric cancer, HCC, NSCLC (adeno and squamous), mesothelioma, pancreatic cancer, HRPC, soft tissue sarcoma; other tumor types after Medical Monitor discussion. Stable CNS metastases ≥4 weeks post-radiotherapy and off steroids ≥14 days are permitted.
  • ≥1 measurable lesion per RECIST v1.1 (prostate cancer with bone-only disease and elevated PSA assessed by PCWG3).
  • Accessible tumor for biopsy
  • Adequate organ/bone marrow function.
  • Willingness and ability to provide informed consent.
  • Negative serum pregnancy test and use of effective contraception through 90 days after last dose for women of childbearing potential.
  • Male participants must use barrier contraception or abstinence and not donate sperm through 90 days after last dose.

Exclusion Criteria:

  • High-risk cardiovascular disease.
  • Concurrent anti-cancer treatment.
  • Active infection requiring systemic treatment within 2 weeks pre-dose.
  • History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years).
  • Active HBV (HBV-DNA >ULN), HCV (HCV-RNA >ULN), or HIV (well-controlled HIV with CD4 ≥350 cells/µL and undetectable viral load permitted); AIDS-defining opportunistic infection within 12 months.
  • Compromised pulmonary function within 6 months pre-dose .
  • Pregnancy or breastfeeding.
  • Recent radiotherapy, systemic anti-tumor therapy, other investigational therapy without appropriate washout.
  • Major surgery ≤4 weeks pre-dose.
  • Unable to swallow tablets or conditions affecting GI absorption.
  • Any medical or psychiatric disorders affecting compliance and/or interpretation of study results.
  • Persistent toxicities from prior anti-cancer therapy (exceptions apply)
  • Clinically significant corneal disease.
  • Unable to comply with prohibited concomitant medication restrictions.

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：なし
  • 介入モデル：単一グループの割り当て
  • 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：SHY-ONC6
Participants receive SHY-ONC6 administered orally once daily. Phase 1a, sequential dose levels are evaluated under accelerated titration and BOIN dose-escalation design. In Phase 1b, participants will be evaluated in disease-specific expansion cohorts and receive SHY-ONC6 at the RP2D range identified in Phase 1a.
薬：SHY-ONC6
Participants receive SHY-ONC6 administered orally once daily in 21-day cycles. SHY-ONC6 will be administered until the participant withdraws from study, experiences unacceptable toxicity or other safety event, or their disease progresses.

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
Incidence of Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs)
時間枠：Dose-limiting toxicities assessed from first dose through Day 21 of Cycle 1 (each cycle is 21 days). Adverse events and serious adverse events collected from first dose through 30 days after last dose.
Adverse events and serious adverse events graded per NCI CTCAE v6.0; supported by laboratory tests, vital signs, physical examinations, and triplicate 12-lead ECG. Dose-limiting toxicities assessed during Cycle 1 (Days 1 through 21).
Dose-limiting toxicities assessed from first dose through Day 21 of Cycle 1 (each cycle is 21 days). Adverse events and serious adverse events collected from first dose through 30 days after last dose.
Maximum Tolerated Dose (MTD)
時間枠：Determined at the end of the Cycle 1 dose-limiting toxicity evaluation period (Cycle 1 is 21 days).
MTD determined using the BOIN (Bayesian Optimal Interval) design, with a target dose-limiting toxicity rate of 0.30, based on dose-limiting toxicity incidence observed during Cycle 1.
Determined at the end of the Cycle 1 dose-limiting toxicity evaluation period (Cycle 1 is 21 days).
Recommended Phase 2 Dose (RP2D)
時間枠：Phase 1a: at the end of Cycle 1 (each cycle is 21 days). Phase 1b: through end of treatment plus a 30-day safety follow-up period.
Phase 1a: RP2D range determined from dose-limiting toxicity, adverse event, and serious adverse event incidence together with the MTD determination. Phase 1b: RP2D defined by integrated safety, efficacy, pharmacodynamic, and pharmacokinetic data.
Phase 1a: at the end of Cycle 1 (each cycle is 21 days). Phase 1b: through end of treatment plus a 30-day safety follow-up period.

二次結果の測定

結果測定
メジャーの説明
時間枠
Maximum Plasma Concentration (Cmax)
時間枠：Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Maximum observed plasma concentration of study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Area Under the Plasma Concentration-Time Curve (AUC)
時間枠：Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Area under the plasma concentration-versus-time curve for study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Time to Maximum Plasma Concentration (Tmax)
時間枠：Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Time from dosing to observed maximum plasma concentration of study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Terminal Elimination Half-Life (t1/2)
時間枠：Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Terminal elimination half-life of study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Trough Plasma Concentration (Ctrough)
時間枠：Pre-dose on Day 15 of Cycle 1 and pre-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Plasma concentration of study drug immediately prior to the next dose.
Pre-dose on Day 15 of Cycle 1 and pre-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Overall Survival (OS)
時間枠：From first dose until death, withdrawal, loss to follow-up, or study termination, assessed up to an estimated 12 months after last dose of study drug.
Time from first dose until death from any cause.
From first dose until death, withdrawal, loss to follow-up, or study termination, assessed up to an estimated 12 months after last dose of study drug.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1b)
時間枠：From first dose through end of treatment plus a 30-day safety follow-up period.
Adverse events and serious adverse events graded per NCI CTCAE v6.0, collected during Phase 1b.
From first dose through end of treatment plus a 30-day safety follow-up period.
Anti-Tumor Activity - Objective Response Rate
時間枠：Baseline through study completion, an average of 18 months.
Objective response rate defined as the proportion of patients with a confirmed best overall response of either complete response or partial response, as determined per investigator assessment by RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
Baseline through study completion, an average of 18 months.
Anti-Tumor Activity - Best Overall Response (BOR)
時間枠：Baseline through study completion, an average of 18 months.
Best response recorded from first dose until disease progression (complete response, partial response, stable disease, or progressive disease), per RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
Baseline through study completion, an average of 18 months.
Anti-Tumor Activity - Time to Response (TTR)
時間枠：From baseline until first documented response, assessed up to an estimated 18 months.
Time from first dose to first documented complete response (CR) or partial response (PR) per RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
From baseline until first documented response, assessed up to an estimated 18 months.
Anti-Tumor Activity - Duration of Response (DOR)
時間枠：Baseline through study completion, an average of 18 months.
Time from first documented complete response (CR) or partial response (PR) to disease progression or death from any cause, per RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
Baseline through study completion, an average of 18 months.
Anti-Tumor Activity - Progression-Free Survival
時間枠：Baseline through study completion, an average of 18 months.
Time from first dose to first documented disease progression per RECIST v1.1 (PCWG3 for prostate cancer with bone disease) or death from any cause.
Baseline through study completion, an average of 18 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

SHY Therapeutics

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 (推定)

2026年6月29日

一次修了 (推定)

2027年5月15日

研究の完了 (推定)

2028年5月15日

試験登録日

最初に提出

2026年7月1日

QC基準を満たした最初の提出物

2026年7月10日

最初の投稿 (実際)

2026年7月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月15日

QC基準を満たした最後の更新が送信されました

2026年7月10日

最終確認日

2026年7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

  • SHY-ONC6-101

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?

いいえ

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

米国で製造され、米国から輸出された製品。

はい

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。

胃癌の臨床試験

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