- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07726212
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are:
Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002
.
Participants will:
Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Medical Director
- Numero di telefono: +86 13306139991
- Email: ke.chen@mlkbiotech.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- 18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
- Life expectancy of 3 month or greater
- participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
- At least one measurable lesion as assessed by RECIST 1.1
- Adequate organ functions.
- ECOG Performance Status (PS) of 0-1
Exclusion Criteria:
- Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
- Known hypersensitivity to either the drug substances or inactive ingredient
- Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
- Participants with QTc >470 msec.
- Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
- Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
- Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: dose escalation
MC002 dose escalation
|
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days.
MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To assess the Number of patients with Adverse Events (AE)
Lasso di tempo: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
|
Any medical event in a participant which may or may not have a causal relationship with this treatment.
|
From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
|
|
Determination of MTD or RP2D
Lasso di tempo: From enrollment until 28 days after last study drug
|
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
|
From enrollment until 28 days after last study drug
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum concentration (Cmax)
Lasso di tempo: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
|
From enrollment until 28 days after last study drug
|
|
ADA
Lasso di tempo: From enrollment until 28 after last study drug
|
Incidence, onset time, and titer of ADAs against MC002
|
From enrollment until 28 after last study drug
|
|
The time taken to reach the maximum concentration (Tmax)
Lasso di tempo: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
|
From enrollment until 28 days after last study drug
|
|
Area Under Curve (AUC)
Lasso di tempo: From enrollment until 28 days after last study drug
|
PK endpoint
|
From enrollment until 28 days after last study drug
|
|
Half life (T1/2)
Lasso di tempo: From enrollment until 28 days after last study drug
|
Half life (T1/2)
|
From enrollment until 28 days after last study drug
|
|
Trough concentration (Cmin)
Lasso di tempo: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
|
From enrollment until 28 days after last study drug
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall response rate (ORR)
Lasso di tempo: From enrollment until 28 days after last study drug.
|
the proportion/percentage of participants with best overall response of CR or PR。
|
From enrollment until 28 days after last study drug.
|
|
progression-free survival (PFS)
Lasso di tempo: From enrollment until 28 days after last study drug.
|
assessed per RECISTv1.1
|
From enrollment until 28 days after last study drug.
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MC002 FIH Study
- Sponsor (Altro numero di sovvenzione/finanziamento: Sponsor)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .