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

September 11, 2023 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
281

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 上海市
      • Shanghai, 上海市, China, 200032
        • Recruiting
        • Ethics Committee of Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
evaluation of the incidence of adverse events (AEs) (part 1)
Time Frame: approximately up to 16 cycles, 21 days a cycle
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)
Time Frame: from Day1 to Day21 in cycle1 of 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)
Time Frame: approximately up to 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
overall response rate (ORR) (part1)
Time Frame: approximately up to 1 year
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)
Time Frame: approximately up to 2 years
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
Time Frame: approximately up to 2 years
Peak Plasma Concentration（Cmax）
approximately up to 2 years
evaluation of AUC of 7MW3711
Time Frame: approximately up to 2 years
Area under the plasma concentration versus time curve (AUC)
approximately up to 2 years
evaluation of t1/2 of 7MW3711
Time Frame: approximately up to 2 years
Half life time（t1/2）
approximately up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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