About this trial
This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
Male or female subjects aged 18 to 75 years (including 18 and 75 years).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.
Disqualifiers
History of another malignancy within 3 years before the first dose of study drug.
Ongoing clinically significant toxicities related to prior treatment.
Grade ≥ 2 peripheral neuropathy.
Severe or uncontrolled gastrointestinal diseases.
Trial design
Single group
Treatments tested in this trial
9MW2821
DrugSubjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
Other anti-cancer therapy
DrugSubjects will receive other anticancer therapy as per protocol
Treatment groups
Trial outcomes
Primary outcomes
Incidence of AE/SAE (phase Ib)
Adverse event (AE), serious adverse event (SAE)
Objective Response Rate, ORR (phase II)
The proportion of participants with complete response (CR) or partial response (PR)
Secondary outcomes
Duration of Response, DOR
Time from the date of the first CR or PR to the earliest date of disease progression or death
Time To Response, TTR
Time from the date of first infusion to the date of CR or PR
Disease Control Rate, DCR
The percentage of subjects who experience CR, PR or stable disease (SD)
Progression-Free Survival, PFS
Time from the date of first infusion to the earliest date of disease progression or death
Sponsors and contacts
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