NCT06008379

A Study of 7MW3711 in Subjects With Advanced Solid Tumors

A Phase 1/2 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

7MW3711 is a antibody-drug conjugate(ADC) drected to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid tumors.

Detailed description

Two parts are included in this study. The part of dose escalation and dose expansion(part 1) will enrolled subjects with advanced solid tumors and is to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or the recommend pahse 2 dose(RP2D) of 7MW3711 in subjects with advanced solid tumors. The part of cohort expansion(part 2) will enrolled subejcts with selected advanced solid tumors and is to assess the preliminary efficacy of 7MW3711 in selected advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	7MW3711 for injection	IV administration of 7MW3711, Q3W, 3 weeks a cycle
DRUG	7MW3711 for injection	IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1

Timeline

• Start date: 2023-08-28
• Primary completion: 2025-08-30
• Completion: 2026-01-30
• First posted: 2023-08-23
• Last updated: 2023-09-13

Locations

5 sites across 1 country: China