First-in-human Study of 7MW4911 in GI Cancer
ConditionGI Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabwell (Shanghai) Bioscience Co., Ltd.
About this trial
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 and above
ECOG 0-1
Life expectancy ≥ 3 months
Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
Disqualifiers
Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
Active, untreated or symptomatic CNS metastasis
Effusions that require frequent drainage
Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
Trial design
Design model
Single group
Treatments tested in this trial
7MW4911
Drugstudy drug
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: 7MW4911Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and rates of adverse events
To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors
Time frame
Up to approximately 2 years2
MTD, RED, and RP2D
To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Tmax of 7MW4911
time to maximum concentration of 7MW4911 in blood
Time frame
up to 3 months2
Cmax of 7MW4911
maximum concentration of 7MW4911 in bloood
Time frame
up to 3 months3
Half life of 7MW4911
time to decrease of 7MW4911 concentration by 50% in blood
Time frame
up to 3 months4
Area under the curve of 7MW4911
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
Time frame
up to 3 monthsOther outcomes
1
Biomarker for efficacy
To explore the relationship between the expression of CDH17 in tumor tissues and other biomarkers and the efficacy and safety of 7MW4911 in patients with advanced colorectal cancer and selected gastrointestinal tumor types
Time frame
Up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov