MC002(ADC)
DrugMC002 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
NCT Number: NCT07726212
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
:
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
Time frame: 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.
Time frame: From enrollment until 28 days after last study drug
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
Time frame: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Time frame: From enrollment until 28 after last study drug
Incidence, onset time, and titer of ADAs against MC002
Time frame: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Time frame: From enrollment until 28 days after last study drug
PK endpoint
Time frame: From enrollment until 28 days after last study drug
Half life (T1/2)
Time frame: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
Time frame: From enrollment until 28 days after last study drug.
the proportion/percentage of participants with best overall response of CR or PR。
Time frame: From enrollment until 28 days after last study drug.
assessed per RECISTv1.1
Contact information is provided by the study sponsor or research team.
Hangzhou MacroLink Biopharmaceutical LLC
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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