A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors

March 8, 2026 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.

A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 With or Without Chemotheray in Patients With Advanced Solid Tumors

This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.

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

A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 with or without Chemotheray in Patients 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.
280

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
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200043
        • Recruiting
        • Shanghai Chest Hospital
        • 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:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  2. Life expectancy of at least 3 months as assessed by the Investigator.
  3. 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.
  4. Measurable or evaluable disease by RECIST v1.1.
  5. Have adequate hematopoietic, renal and hepatic functions.
  6. Men or women willing to use adequate contraceptive measures throughout the study.

Exclusion Criteria:

  1. Have other prior malignancies within 3 years before the first administration.
  2. Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
  3. Have significant, uncontrolled, or active cardiovascular disease.
  4. Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
  5. Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V6.0.
  6. Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
  7. Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
  8. Prior treatment with B7-H3 targeted agents.
  9. Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
  10. 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: Phase 1b: Safety run-in
Multiple dose levels of 7MW3711 will be explored in combination with JS207 with or without Chemotheray administered intravenously (IV) at a fixed dose as specified in the protocol.
Drug: Carboplatin
Carboplatin will be administered as IV infusion.
Drug: Cisplatin
Cisplatin will be administered as IV infusion.
Drug: 7MW3711
7MW3711 will be administered as IV infusion.
Drug: JS207
JS207 will be administered as IV infusion.
Experimental: Phase 2: Dose expansion
7MW3711 will be administered at the selected RDE in combination with JS207 with or without Chemotheray administered IV at a fixed dose as specified in the protocol.
Drug: Carboplatin
Carboplatin will be administered as IV infusion.
Drug: Cisplatin
Cisplatin will be administered as IV infusion.
Drug: 7MW3711
7MW3711 will be administered as IV infusion.
Drug: JS207
JS207 will be administered as IV infusion.

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
Incidence and severity of adverse events (AEs)
Time Frame: Up to approximately 2 years
AEs are assessed based on NCI CTCAE v6.0.
Up to approximately 2 years
Maximum tolerate dose（MTD)
Time Frame: Up to approximately 2 years
MTD of 7MW3711
Up to approximately 2 years
Recommended Expansion Dose (RED)
Time Frame: Up to approximately 2 years
RED of 7MW3711
Up to approximately 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
Immunogenicity
Time Frame: Up to approximately 2 years
Incidence and rates of ADA
Up to approximately 2 years
Area Under the Concentration-time Curve (AUC)
Time Frame: Up to approximately 2 years
AUC of 7MW3711
Up to approximately 2 years
Maximum concentration (Cmax)
Time Frame: Up to approximately 2 years
Cmax of 7MW3711
Up to approximately 2 years
Plasma clearance (CL)
Time Frame: Up to approximately 2 years
CL of 7MW3711
Up to approximately 2 years
Half-life (t1/2)
Time Frame: Up to approximately 2 years
t1/2 of 7MW3711
Up to approximately 2 years
Time to peak drug concentration (Tmax)
Time Frame: Up to approximately 2 years
Tmax of 7MW3711
Up to approximately 2 years
Investigator-assessed progression-free survival (PFS)
Time Frame: Up to approximately 2 years
PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first.
Up to approximately 2 years
Overall survival (OS)
Time Frame: Up to approximately 2 years
OS defined as the time interval from the first study drug administration to death due to any cause.
Up to approximately 2 years
Investigator-assessed disease control rate (DCR)
Time Frame: Up to approximately 2 years
DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
Up to approximately 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.
February 11, 2026

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.
December 31, 2027

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.
December 31, 2029

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).
March 8, 2026

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.
March 8, 2026

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.
March 12, 2026

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.
March 12, 2026

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.
March 8, 2026

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.
March 1, 2026

More Information

Terms related to this study

Keywords

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-CP202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings