First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMabwell (Shanghai) Bioscience Co., Ltd.
About this trial
This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18~75.
ECOG 0-1.
Life expectancy ≥ 3 months.
Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
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
Drug7MW4911 for IV infusion of various dose strengths administered
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
Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (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
Objective response rate
Proportion of patients whose turmor response meet the criteria of complete response or partial response
Time frame
Up to approximately 2 years2
Progression-free survival
Duration in months from treatment to disease progression or death from any cause, whichever occurs first.
Time frame
Up to approximately 2 years3
Immunogenicity
Incidence and rates of ADA
Time frame
Up to approximately 2 years4
Tmax
Time to maximum concentration of 7MW4911 in blood
Time frame
Up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov