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Study of MC001 in Patients With Advanced Solid Tumours

4 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Cingapura
      • Singapore, Cingapura, 119228
        • National University Cancer Institute Singapore
        • Contato:
        • Contato:
        • Investigador principal:
          • Robert J Walsh, Medical Degree
        • Subinvestigador:
          • Boon Cher Goh, Medical Degree

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

21 anos a 99 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dose Level 1

0.3 mg/kg
Medicamento: 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.
Experimental: Dose Level 2

0.6 mg/kg
Medicamento: 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.
Experimental: Dose Level 3

1.0 mg/kg
Medicamento: 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.
Experimental: Dose Level 4

1.6 mg/kg
Medicamento: 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.
Experimental: Dose Level 5

2.2 mg/kg
Medicamento: 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.
Experimental: Dose Level 6

2.8 mg/kg
Medicamento: 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.
Experimental: Dose Level 7

3.2 mg/kg
Medicamento: 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.
Experimental: Dose Expansion - PDAC

MC001 at the recommended dose for expansion (RDE), in patients with FRα-positive PDAC.
Medicamento: 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.
Experimental: Dose Expansion - NPC

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of Adverse Events (AEs)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National University Hospital, Singapore

Colaboradores

Medicovestor, Inc

Investigadores

  • Investigador principal: Robert J Walsh, Medical Degree, National University Hospital, Singapore

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de novembro de 2026

Conclusão Primária (Estimado)

30 de novembro de 2030

Conclusão do estudo (Estimado)

30 de novembro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

25 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de novembro de 2026

Primeira postagem (Real)

10 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PA01/02/26
  • CTA2600101 (Outro identificador: Health Sciences Authority)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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