A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors

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

7MW3711 is an antibody-drug conjugate(ADC) directed 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: 7MW3711 for injection; Drug: 7MW3711 for injection

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 phase 2 dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.

• Study Type: Interventional
• Enrollment (Estimated): 281
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jian Zhang, Ph.D; Phone Number: 18017312991; Email: syner2000@163.com

Study Locations

• China
  • 上海市
    • Shanghai, 上海市, China, 200032
      • Recruiting
      • Ethics Committee of Fudan University Shanghai Cancer Center
      • Contact: 剑 张, Doctor; Phone Number: 18017312991; Email: syner2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Life expectancy of at least 3 months as assessed by the Investigator.
• 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.
• An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue block or at least 5 unstained slides) or a fresh tissue sample should be provided. If the tissue sample cannot be provided during dose escalation, enrollment into the study is allowed after discussion with the Investigator
• Measurable or evaluable disease by RECIST v1.1.
• Have adequate hematopoietic, renal and hepatic functions.
• Men or women willing to use adequate contraceptive measures throughout the study.

Exclusion Criteria:

• 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.
• Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V5.0.
• Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
• Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
• Prior treatment with B7-H3 targeted agents.
• Have received chemotherapy, immunotherapy, curative radiation within 3 weeks prior to the first administration or targeted molecular within 2 weeks prior to first administration. have received Chinese patent medicine or Chinese herbs of anti-tumor indications within 1 weeks prior to the first administration.
• Have received any systemic immunosuppressants within 2 weeks prior to the first administration except for topical corticosteroids.
• Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
• History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
• Pregnant, or nursing females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation and dose expansion; All subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion	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
Experimental: Cohort expansion; All subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of the incidence of adverse events (AEs) (part 1)	Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0	approximately up to 16 cycles, 21 days a cycle
Identification of the MTD and /or RP2D of 7MW3711(part 1)	MTD(maximum tolerated dose) and /or RP2D(recommended phase II dose)of 7MW3711(part 1)	from Day1 to Day21 in cycle1 of part 1
Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors(part 2)	ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)	approximately up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate (ORR) (part1)	ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) based on RECIST version 1.1	approximately up to 1 year
evaluation of the incidence of adverse events (AEs) (part 2)	Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0	approximately up to 2 years
evaluation of Peak Plasma Concentration (Cmax) of 7MW3711	Peak Plasma Concentration（Cmax）	approximately up to 2 years
evaluation of AUC of 7MW3711	Area under the plasma concentration versus time curve (AUC)	approximately up to 2 years
evaluation of t1/2 of 7MW3711	Half life time（t1/2）	approximately up to 2 years

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 7MW3711-2023-CP101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No