A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou MacroLink Biopharmaceutical LLC
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
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
Treatment groups
143 Participants
are divided into 1 treatment groupGroup A: dose escalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the Number of patients with Adverse Events (AE)
Any medical event in a participant which may or may not have a causal relationship with this treatment.
Time frame
From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up2
Determination of MTD or RP2D
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
Time frame
From enrollment until 28 days after last study drugSecondary outcomes
1
Maximum concentration (Cmax)
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Time frame
From enrollment until 28 days after last study drug2
ADA
Incidence, onset time, and titer of ADAs against MC002
Time frame
From enrollment until 28 after last study drug3
The time taken to reach the maximum concentration (Tmax)
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 drug4
Area Under Curve (AUC)
PK endpoint
Time frame
From enrollment until 28 days after last study drugOther outcomes
1
Overall response rate (ORR）
the proportion/percentage of participants with best overall response of CR or PR。
Time frame
From enrollment until 28 days after last study drug.2
progression-free survival (PFS)
assessed per RECISTv1.1
Time frame
From enrollment until 28 days after last study drug.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: