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進行性または転移性固形腫瘍におけるTST001の安全性と忍容性を評価する試験

2026年9月28日 更新者：Transcenta Therapeutics (Hangzhou) Co., Ltd.

局所進行性または転移性固形腫瘍の患者に単剤療法として、またはニボルマブと組み合わせて投与された TST001 の安全性、忍容性、および薬物動態を評価するための第 I/IIa 相臨床試験

This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

Part A of the trial will consist of two cohorts, one dosed every 2 weeks and one dosed every 3 weeks in a standard 3+3 design. Part A is the dose finding portion of the trial.

18 to 36 participants will be enrolled.

Part B consists of 3 cohorts:

Cohort A is for patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma. Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus Nivolumab and mFOLFOX6. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor's CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort A.

Cohort B is for patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies. Patient will receive TST001 plus Nivolumab. No selection based on CLDN18.2 expression will be required for the safety run-in (3-6 patients). Patients with CLDN18.2 expression in tumor tissue tested by the central laboratory will be enrolled in the expansion phase. Safety run-in phase will follow 3+3 rule with two dose levels, TST001 3mg/kg and 6mg/kg Q3W combined with nivolumab. Approximately 30 patients will be enrolled in Cohort B including the patients in the safety run-in phase.

Cohort C is for patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus gemcitabine and albumin-bound paclitaxel. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor's CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort C.

研究の種類

介入

入学 (推定)

150

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。

研究場所

  • アメリカ
    • Arizona
      • Gilbert、Arizona、アメリカ、85234
        • Banner MD Anderson
      • Tucson、Arizona、アメリカ、85724
        • University of Arizona
    • Connecticut
      • New Haven、Connecticut、アメリカ、06519
        • Yale University
    • Florida
      • Sarasota、Florida、アメリカ、34232
        • Florida Cancer Specialists
    • Georgia
      • Atlanta、Georgia、アメリカ、30033
        • Emory University
    • Kansas
      • Kansas City、Kansas、アメリカ、66160
        • University of Kansas, School of Medicine
    • Missouri
      • St Louis、Missouri、アメリカ、63110
        • Washington University
    • New York
      • New York、New York、アメリカ、10065
        • Memorial Sloan Kettering
      • Stony Brook、New York、アメリカ、11794
        • Stony Brook Cancer Center
    • North Carolina
      • Winston-Salem、North Carolina、アメリカ、27157
        • Wake Forest Baptist Comprehensive Cancer Center
    • Ohio
      • Canton、Ohio、アメリカ、44718
        • Gabrail Cancer Research
    • Pennsylvania
      • Gettysburg、Pennsylvania、アメリカ、17325
        • Pennsylvania Cancer Specialist Research Institute
      • Pittsburgh、Pennsylvania、アメリカ、15212
        • Allegheny Hospital
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • Sarah Cannon Research Institute
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt University
    • Texas
      • Austin、Texas、アメリカ、78704
        • NEXT Oncology
    • Washington
      • Seattle、Washington、アメリカ、98104
        • Swedish Cancer Institute
    • Wisconsin
      • Milwaukee、Wisconsin、アメリカ、53226
        • Medical College of Wisconsin

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:

  • Male or female ≥ 18 years.
  • Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors.

Part A only:

* Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy.

Part B only:

  • Cohort A: Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received one infusion of mFOLFOX6 plus nivolumab during the screening period.
  • Cohort B: Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies; adjuvant or neoadjuvant therapy could be regarded as one line of therapy only if disease progressed or recurred during these treatments or within 6 months or less after completion of these treatments.
  • Cohort C: Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received up to 2 infusions of Gemcitabine + albumin-bound paclitaxel (with one week between each infusion) during the screening period.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 .
  • Patients with adequate cardiac, liver, renal function, etc.

Exclusion Criteria

  • Symptomatic central nervous system metastases.
  • Prior treatment with any CLDN18.2 target agents
  • Allergy or sensitivity to TST001 or known allergies to comparable drugs
  • Documented history of multiple other allergies requiring interventions
  • Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina, NYHA class III or IV heart failure or uncontrolled arrhythmia within 6 months of study entry, severe QTc prolongation, concomitant risks for QTc prolongation.
  • Concurrent malignancy within 5 years prior to entry except adequately treated certain types of cancer
  • Active and clinically significant infections, known uncontrolled infections with hepatitis B, hepatitis C, known human immunodeficiency virus with acquired immunodeficiency syndrome related illness
  • Any condition that the investigator or primary physician believes may not be appropriate for participating in the study.

Other protocol-defined Inclusion/Exclusion Criteria could apply.

.

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：並列代入
  • 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：Part A Q2W

Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested.
薬：TST001

TST001 is a humanized IgG1 monoclonal antibody.
実験的：Part A Q3W

Dosed every 3 weeks IV with TST001, starting dose is 3 mg/kg, and multiple dose levels will be tested.
薬：TST001

TST001 is a humanized IgG1 monoclonal antibody.
実験的：Part B Cohort A

Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma.
薬：TST001

TST001 is a humanized IgG1 monoclonal antibody.

薬：Nivolumab Injection [Opdivo]

Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies

薬：mFOLFOX6

mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.
実験的：Part B Cohort B

Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies.
薬：TST001

TST001 is a humanized IgG1 monoclonal antibody.

薬：Nivolumab Injection [Opdivo]

Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies
実験的：Part B Cohort C

Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma.
薬：TST001

TST001 is a humanized IgG1 monoclonal antibody.

薬：Gemcitabine

Chemotherapy medication

他の名前：
  • ジェムザール
薬：Albumin-Bound Paclitaxel

Chemotherapy medication

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
Participant Safety as characterized by frequency and severity of adverse events
時間枠：up to 100 days following last dose

Characterization of TST001 safety profile including frequency and severity of adverse events that are related to treatment.
up to 100 days following last dose
Maximum Tolerated Dose (MTD or Recommended Phase 2 Dose (RP2D)
時間枠：up to 100 days following last dose

As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort
up to 100 days following last dose
Participant Safety and Tolerability of TST001 in combination with Nivolumab as characterized by frequency and severity of adverse events
時間枠：Up to 100 days following last dose

Characterization of TST001 + Nivolumab safety profile including frequency and severity of adverse events that are related to treatment.
Up to 100 days following last dose
Participant Safety and Tolerability of TST001 in combination with Nivolumab and mFOLFOX6 as characterized by frequency and severity of adverse events
時間枠：Up to 100 days following last dose

Characterization of TST001 + Nivolumab + mFOLFOX6 safety profile including frequency and severity of adverse events that are related to treatment.
Up to 100 days following last dose
Participant Safety and Tolerability of TST001 in combination with gemcitabine and albumin-bound paclitaxel as characterized by frequency and severity of adverse events
時間枠：Up to 100 days following last dose

Characterization of TST001 + Gemcitabine + albumin-bound paclitaxel safety profile including frequency and severity of adverse events that are related to treatment.
Up to 100 days following last dose

二次結果の測定

結果測定
メジャーの説明
時間枠
Immunogenicity
時間枠：up to 30 days following last dose

by measurement of Incidence of anti-drug antibodies (ADA)
up to 30 days following last dose
Objective response rate (ORR)
時間枠：up to 24 months, until disease progression or start of another anti-cancer therapy

as measured by RECIST 1.1
up to 24 months, until disease progression or start of another anti-cancer therapy
Duration of Response (DOR)
時間枠：up to 24 months, until disease progression or start of another anti-cancer therapy

duration of response (DOR)
up to 24 months, until disease progression or start of another anti-cancer therapy
Progression free survival (PFS)
時間枠：up to 24 months, until disease progression or start of another anti-cancer therapy

as measured by RECIST v1.1
up to 24 months, until disease progression or start of another anti-cancer therapy
PK parameters
時間枠：Up to 30 days following last dose

Maximum serum concentration (Cmax)
Up to 30 days following last dose
PK
時間枠：Up to 30 days following last dose

time to reach maximum serum concentration (Tmax)
Up to 30 days following last dose
PK
時間枠：Up to 30 days following last dose

Area Under the Curve
Up to 30 days following last dose

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

Transcenta Therapeutics (Hangzhou) Co., Ltd.

協力者

Bristol-Myers Squibb

捜査官

  • スタディディレクター：Charlie Qi, MD、Suzhou Transcenta Therapeutics Co.

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)

2020年5月28日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年9月30日

試験登録日

最初に提出

2020年5月7日

QC基準を満たした最初の提出物

2020年5月15日

最初の投稿 (実際)

2020年5月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月29日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2025年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TST001-1001

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?

はい

IPD プランの説明

As described below. Patient personal data will be kept confidential as per HIPAA.

IPD 共有時間枠

Clinical Study Report will become available approximately 60 to 90 days after last patient last visit. Each Investigator will receive one to keep. Protocol will be received prior to study start for each investigator.

IPD 共有アクセス基準

Be an active investigator in the TST001-1001 trial

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • CSR

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。

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