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Study of MC001 in Patients With Advanced Solid Tumours

2026年11月4日 更新者：National University Hospital, Singapore

Phase I First-in-Human Study of MC001 (ADoBind Dimeric IgG-Monomethyl Auristatin E), a First-in-Class Dimeric Antibody-Drug Conjugate Targeting Folate Receptor Alpha (FRα), in Patients With Advanced Solid Tumours

The goal of this clinical trial is to evaluate the safety and tolerability of MC001 and to determine the appropriate dose for further development in adults with advanced solid tumours, with expansion cohorts in pancreatic ductal adenocarcinoma (PDAC) and nasopharyngeal carcinoma (NPC). The main questions it aims to answer are:

  • What is the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDE) of MC001?
  • How does MC001 behave in the body following single and multiple doses?
  • Does MC001 show preliminary antitumour activity in patients with PDAC and NPC?
  • What are the pharmacodynamic effects of MC001?
  • What medical problems do participants have when taking MC001?

Research participants will:

  • Receive MC001 every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, or at the investigator's discretion.
  • Visit the clinic every 21 days for drug administration, biopsy, and assessments including blood tests, eye tests, and imaging.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

This is a first-in-human, open-label, Phase I clinical trial evaluating MC001 administered as monotherapy via intravenous infusion every 21 days (Q3W) in patients with advanced folate receptor-expressing solid tumours. Each treatment cycle is defined as 21 days.

The study comprises two sequential components: a Dose Escalation Phase followed by a Dose Expansion Phase. During dose escalation, the mTPI-2 method will be used to determine the appropriate dose across 7 dose levels. Following completion of dose escalation, expansion cohorts will enrol patients with PDAC and NPC at the recommended dose for expansion (RDE) to further evaluate safety and preliminary antitumour activity.

研究の種類

介入

入学 (推定)

80

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

  • シンガポール
      • Singapore、シンガポール、119228
        • National University Cancer Institute Singapore
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Robert J Walsh, Medical Degree
        • 副調査官：
          • Boon Cher Goh, Medical Degree

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

21年～99年 (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 ≥21 years at the time of informed consent.

  2. Histology or cytology confirmation of advanced or metastatic solid tumour that is unresectable or refractory to standard therapy, or for which no standard therapy is available.

  3. Tumour FRα expression, defined as:

    • Dose escalation: No predefined FRα expression level required for inclusion into dose escalation.
    • Dose expansion: Moderate to high membranous FRα expression in ≥50% of tumour cells, as assessed by immunohistochemistry (IHC) using an assay validated for this study.

  4. Tumour type eligibility:

    • Dose escalation: all solid tumours are eligible for escalation phase.
    • Dose expansion: restricted to PDAC and NPC only.

  5. Measurable disease per RECIST version 1.1.

  6. Mandatory baseline tumour biopsy, obtained prior to first administration of MC001, unless deemed unsafe by the investigator.

  7. ECOG performance status of 0 or 1.

  8. Adequate organ and marrow function, defined as:

    • Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
    • Platelet count ≥100 × 10⁹/L
    • Haemoglobin ≥9.0 g/dL
    • Creatinine clearance ≥50 mL/min (Cockcroft-Gault)
    • AST and ALT ≤3 × ULN (≤5 × ULN if liver metastases present)
    • Total bilirubin ≤1.5 × ULN

  9. Baseline imaging feasibility, defined as:

    • Ability to undergo contrast-enhanced CT at baseline, or
    • MRI abdomen/pelvis with non-contrast CT thorax if contrast CT is contraindicated.

  10. Recovered from prior therapy-related toxicities to:

    o Grade ≤1 per CTCAE v6.0

  11. Life expectancy ≥12 weeks, as assessed by the investigator.

  12. Women of childbearing potential (WOCBP) must:

    • Have a negative pregnancy test at screening.
    • Agree to use highly effective contraception during the study and for 6 months after the last dose of MC001.
    • Subjects not considered WOCBP are those without menses for ≥ 12 consecutive months, and those who have undergone hysterectomy and/or bilateral salpingo-oophorectomy. WOCBP must be willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study and 6 months after the last dose of treatment.

  13. Male participants with partners of childbearing potential are required to use barrier contraception in addition to having their partner use another method of contraception during the study and for 6 months after the last dose of treatment. Male participants will also be advised to abstain from sexual intercourse with pregnant or lactating women, or to use condoms.

  14. Ability to understand and voluntarily sign written informed consent.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

  1. Prior exposure to MMAE-containing antibody-drug conjugates, or known hypersensitivity to MMAE or related compounds.

  2. Peripheral neuropathy ≥ Grade 2 at baseline.

  3. Known active central nervous system (CNS) metastases or carcinomatous meningitis, unless:

    • Previously treated
    • Clinically stable for ≥4 weeks
    • Not requiring corticosteroids >10 mg prednisolone (or equivalent) daily.

  4. Clinically significant ocular disease, including:

    • Active keratitis
    • Severe dry eye requiring ongoing ophthalmologic intervention
    • Corneal ulceration or other conditions that may increase ADC-related ocular risk.

  5. Uncontrolled intercurrent illness, including but not limited to:

    • Active infection requiring systemic therapy
    • Symptomatic congestive heart failure or LVEF < 40% on screening echocardiogram
    • Unstable angina
    • Significant cardiac arrhythmia including QTc > 500ms
    • Psychiatric illness or social situations limiting compliance.

  6. Receipt of any investigational study drug within 28 days or 5 half-lives (whichever is shorter) prior to the first administration of MC001.

  7. Major surgery within 4 weeks prior to first administration of MC001.

  8. Pregnant or breastfeeding women.

  9. Known uncontrolled viral infections, including:

    • Active hepatitis B or C with uncontrolled viral load

    • Known HIV infection with detectable viral load.

      *Hepatitis B virus (HBV):

      • Participants who are HBsAg positive are eligible provided that:

    • They have received antiviral therapy for HBV for at least 4 weeks prior to the first dose of MC001, and they have an undetectable HBV viral load at screening.

    • Note: Participants must remain on HBV antiviral therapy throughout study treatment and follow local guidelines for continuation of antiviral therapy after completion of study treatment.

    • Patients who are HBsAg negative, and anti-HB core total positive are not considered to have active hepatitis if HB viral load is undetectable.

      • Hepatitis C virus (HCV):

    • Participants with a history of HCV infection are eligible provided that:

      1. HCV viral load is undetectable at screening, and

      2. Curative antiviral therapy was completed at least 12 weeks prior to initiation of study treatment.

        • Participants with active, uncontrolled viral hepatitis not meeting the above criteria will be excluded

  10. Second active malignancy requiring treatment.

  11. Any condition that, in the investigator's judgment, would place the participant at unacceptable risk or interfere with interpretation of study results.

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：Dose Level 1

0.3 mg/kg
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Level 2

0.6 mg/kg
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Level 3

1.0 mg/kg
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Level 4

1.6 mg/kg
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Level 5

2.2 mg/kg
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Level 6

2.8 mg/kg
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Level 7

3.2 mg/kg
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Expansion - PDAC

MC001 at the recommended dose for expansion (RDE), in patients with FRα-positive PDAC.
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.
実験的：Dose Expansion - NPC

MC001 at the RDE, in patients with FRα-positive NPC.
薬：MC001

MC001 will be administered as an intravenous infusion once every 21 days at the dose level and schedule assigned per protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or at the discretion of the investigator. MC001 is supplied by Medicovestor, Inc.

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 Adverse Events (AEs)
時間枠：From informed consent until 30 days after the last dose of MC001 (approximately 2 years)

Incidence and severity of adverse events (AEs) occurring during the study period, assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0. CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to an adverse event).
From informed consent until 30 days after the last dose of MC001 (approximately 2 years)
Incidence of Serious Adverse Events (SAEs)
時間枠：From screening until end of treatment (up to approximately 2 years)

Number of participants experiencing one or more serious adverse events (SAEs) during the study period.
From screening until end of treatment (up to approximately 2 years)
Incidence of dose-limiting toxicities
時間枠：During Cycle 1 (21 days)

Number of participants experiencing a dose-limiting toxicity (DLT) during Cycle 1. DLTs are protocol-defined adverse events occurring during the first 21 days of treatment that are considered at least possibly related to the study drug and are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
During Cycle 1 (21 days)
Maximum Tolerated Dose (MTD)
時間枠：From first dose until completion of dose escalation (up to approximately 24 months)

The maximum tolerated dose (MTD) is determined using the modified Toxicity Probability Interval (mTPI-2) design and is defined as the highest dose level at which the observed rate of dose-limiting toxicities (DLTs) during Cycle 1 does not exceed the prespecified target toxicity probability.
From first dose until completion of dose escalation (up to approximately 24 months)
Maximum Administered Dose (MAD)
時間枠：From first dose until completion of dose escalation (up to approximately 24 months)

The maximum administered dose (MAD) is determined as the highest dose level of MC001 evaluated during the dose-escalation phase, regardless of whether a maximum tolerated dose (MTD) is reached.
From first dose until completion of dose escalation (up to approximately 24 months)
Recommended Dose for Expansion (RDE)
時間枠：From first dose until determination of the recommended dose for expansion (approximately 6 to 12 months)

The recommended dose for expansion (RDE) is selected for evaluation in the expansion cohorts based on an integrated assessment of dose-limiting toxicities (DLTs), overall safety and tolerability, pharmacokinetic data, and preliminary evidence of antitumour activity. The RDE may be equal to or lower than the maximum tolerated dose (MTD).
From first dose until determination of the recommended dose for expansion (approximately 6 to 12 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression-Free Survival (PFS)
時間枠：From first dose until documented disease progression or death from any cause, up to approximately 2 years

Progression-free survival (PFS), defined as the time from first dose of MC001 to documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
From first dose until documented disease progression or death from any cause, up to approximately 2 years
Overall Survival (OS)
時間枠：From first dose until death from any cause, up to approximately 2 years

Overall survival (OS), defined as the time from first dose of MC001 to death from any cause.
From first dose until death from any cause, up to approximately 2 years
Maximum Observed Plasma Concentration (Cmax) of MC001
時間枠：From pre-dose until end of treatment (up to approximately 2 years)

Maximum observed plasma concentration (Cmax) of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE) following administration of MC001.
From pre-dose until end of treatment (up to approximately 2 years)
Changes in ADCC Activity
時間枠：From baseline until end of treatment (up to approximately 2 years)

Changes from baseline in antibody-dependent cellular cytotoxicity (ADCC) activity assessed using protocol-defined immune correlative analyses of peripheral blood samples collected during treatment.
From baseline until end of treatment (up to approximately 2 years)
Objective Response Rate (ORR)
時間枠：From first dose until disease progression, withdrawal, or end of treatment (up to approximately 2 years)

Objective response rate (ORR), defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1.
From first dose until disease progression, withdrawal, or end of treatment (up to approximately 2 years)
Change From Baseline in Serum CA19-9
時間枠：From baseline until end of treatment (up to approximately 2 years)

Change from baseline in serum carbohydrate antigen 19-9 (CA19-9) levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001.
From baseline until end of treatment (up to approximately 2 years)
Change From Baseline in Plasma Epstein-Barr Virus DNA
時間枠：From baseline until end of treatment (up to approximately 2 years)

Change from baseline in plasma Epstein-Barr virus (EBV) DNA levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001.
From baseline until end of treatment (up to approximately 2 years)
Change From Baseline in Serum CA-125
時間枠：From baseline until end of treatment (up to approximately 2 years)

Change from baseline in serum cancer antigen 125 (CA-125) levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001.
From baseline until end of treatment (up to approximately 2 years)
Change From Baseline in Carcinoembryonic Antigen
時間枠：From baseline until end of treatment (up to approximately 2 years)

Change from baseline in serum carcinoembryonic antigen (CEA) levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001.
From baseline until end of treatment (up to approximately 2 years)
Time to Maximum Observed Plasma Concentration (Tmax) of MC001
時間枠：From pre-dose until end of treatment (up to approximately 2 years)

Time to reach maximum observed plasma concentration (Tmax) of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE) following administration of MC001.
From pre-dose until end of treatment (up to approximately 2 years)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MC001
時間枠：From pre-dose until end of treatment (up to approximately 2 years)

Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) for conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE).
From pre-dose until end of treatment (up to approximately 2 years)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCτ) of MC001
時間枠：From pre-dose until end of treatment (up to approximately 2 years)

Area under the plasma concentration-time curve over the dosing interval (AUCτ) for conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE).
From pre-dose until end of treatment (up to approximately 2 years)
Terminal Elimination Half-life (t½) of MC001
時間枠：From pre-dose until end of treatment (up to approximately 2 years)

Terminal elimination half-life (t½), where estimable, of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE).
From pre-dose until end of treatment (up to approximately 2 years)
Trough Plasma Concentration (Ctrough) of MC001
時間枠：From pre-dose until end of treatment (up to approximately 2 years)

Trough plasma concentration (Ctrough) of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE).
From pre-dose until end of treatment (up to approximately 2 years)
Accumulation Ratio (C4/C1) of MC001
時間枠：From pre-dose until end of treatment (up to approximately 2 years)

Accumulation ratio based on plasma concentration following Cycle 4 and Cycle 1 dosing (C4/C1) for conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE).
From pre-dose until end of treatment (up to approximately 2 years)

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

National University Hospital, Singapore

協力者

Medicovestor, Inc

捜査官

  • 主任研究者：Robert J Walsh, Medical Degree、National University Hospital, Singapore

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11月16日

一次修了 (推定)

2030年11月30日

研究の完了 (推定)

2031年11月30日

試験登録日

最初に提出

2026年10月25日

QC基準を満たした最初の提出物

2026年11月4日

最初の投稿 (実際)

2026年11月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月10日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11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

  • PA01/02/26
  • CTA2600101 (その他の識別子：Health Sciences Authority)

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

A decision on whether to share Individual Participant Data (IPD) has not yet been made at this stage of the study.

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。

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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