A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMabwell (Shanghai) Bioscience Co., Ltd.
About this trial
This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Life expectancy of at least 3 months as assessed by the Investigator.
Phase 1b: Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies. Phase 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors.
Measurable or evaluable disease by RECIST v1.1.
Disqualifiers
Have other prior malignancies within 3 years before the first administration.
Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
Have significant, uncontrolled, or active cardiovascular disease.
Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
Trial design
Design model
Sequential
Treatments tested in this trial
7MW3711
Drug7MW3711 will be administered as IV infusion.
JS207
DrugJS207 will be administered as IV infusion.
Cisplatin
DrugCisplatin will be administered as IV infusion.
Carboplatin
DrugCarboplatin will be administered as IV infusion.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Phase 1b: Safety run-inExperimental treatment 4 interventions
Group B: Phase 2: Dose expansionExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events (AEs)
AEs are assessed based on NCI CTCAE v6.0.
Time frame
Up to approximately 2 years2
Maximum tolerate dose（MTD)
MTD of 7MW3711
Time frame
Up to approximately 2 years3
Recommended Expansion Dose (RED)
RED of 7MW3711
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Area Under the Concentration-time Curve (AUC)
AUC of 7MW3711
Time frame
Up to approximately 2 years2
Maximum concentration (Cmax)
Cmax of 7MW3711
Time frame
Up to approximately 2 years3
Plasma clearance (CL)
CL of 7MW3711
Time frame
Up to approximately 2 years4
Half-life (t1/2)
t1/2 of 7MW3711
Time frame
Up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov