- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Medical Director
- Numéro de téléphone: +86 13306139991
- E-mail: ke.chen@mlkbiotech.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To assess the Number of patients with Adverse Events (AE)
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum concentration (Cmax)
Délai: 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
Délai: 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)
Délai: 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)
Délai: From enrollment until 28 days after last study drug
|
PK endpoint
|
From enrollment until 28 days after last study drug
|
|
Half life (T1/2)
Délai: 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)
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall response rate (ORR)
Délai: 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)
Délai: From enrollment until 28 days after last study drug.
|
assessed per RECISTv1.1
|
From enrollment until 28 days after last study drug.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MC002 FIH Study
- Sponsor (Autre subvention/numéro de financement: Sponsor)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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