Solid TumorPhase 1/2NCT07466160
A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors
A Phase 1/2 study testing 7MW3711, JS207 and Cisplatin in people with Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- 7MW3711, JS207 and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2026to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Have adequate hematopoietic, renal and hepatic functions.
- Men or women willing to use adequate contraceptive measures throughout the study.
Who cannot join
- 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 V6.0.
- Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
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- Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
- Prior treatment with B7-H3 targeted agents.
- Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
- Pregnant, or nursing females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200043
Shun Lu, Doctor, 021-22200000 ext. 3121, shun_lu@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- 7MW3711, JS207, Cisplatin, Carboplatin
- Keywords
- NSCLC, SCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7MW3711Drug
7MW3711 will be administered as IV infusion.
JS207Drug
JS207 will be administered as IV infusion.
CisplatinDrug
Cisplatin will be administered as IV infusion.
CarboplatinDrug
Carboplatin will be administered as IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: Safety run-in | Experimental | 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. Receives: Drug: 7MW3711; Drug: JS207; Drug: Cisplatin; Drug: Carboplatin |
| Phase 2: Dose expansion | Experimental | 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. Receives: Drug: 7MW3711; Drug: JS207; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
AEs are assessed based on NCI CTCAE v6.0.
Measured: Up to approximately 2 years
Maximum tolerate dose（MTD)
MTD of 7MW3711
Measured: Up to approximately 2 years
Recommended Expansion Dose (RED)
RED of 7MW3711
Measured: Up to approximately 2 years
Secondary outcomes (9)
Area Under the Concentration-time Curve (AUC)
AUC of 7MW3711
Measured: Up to approximately 2 years
Maximum concentration (Cmax)
Cmax of 7MW3711
Measured: Up to approximately 2 years
Plasma clearance (CL)
CL of 7MW3711
Measured: Up to approximately 2 years
Half-life (t1/2)
t1/2 of 7MW3711
Measured: Up to approximately 2 years
Time to peak drug concentration (Tmax)
Tmax of 7MW3711
Measured: Up to approximately 2 years
Investigator-assessed progression-free survival (PFS)
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.
Measured: Up to approximately 2 years
Overall survival (OS)
OS defined as the time interval from the first study drug administration to death due to any cause.
Measured: Up to approximately 2 years
Investigator-assessed disease control rate (DCR)
DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
Measured: Up to approximately 2 years
Immunogenicity
Incidence and rates of ADA
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start11 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466160
- Sponsor's protocol ID
- 7MW3711-CP202
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07466160
- Acronym / sponsor ID
- 7MW3711-CP202
- Conditions
- Solid Tumor
- Keywords
- NSCLC, SCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: Safety run-in | Experimental | Drug: 7MW3711, Drug: JS207, Drug: Cisplatin, Drug: CarboplatinMultiple 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. |
| Phase 2: Dose expansion | Experimental | Drug: 7MW3711, Drug: JS207, Drug: Cisplatin, Drug: Carboplatin7MW3711 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Have adequate hematopoietic, renal and hepatic functions.
Key exclusion criteria (10 listed)
- 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 V6.0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7MW37117MW3711 will be administered as IV infusion. | Drug | Phase 1b: Safety run-in, Phase 2: Dose expansion |
| JS207JS207 will be administered as IV infusion. | Drug | Phase 1b: Safety run-in, Phase 2: Dose expansion |
| CisplatinCisplatin will be administered as IV infusion. | Drug | Phase 1b: Safety run-in, Phase 2: Dose expansion |
| CarboplatinCarboplatin will be administered as IV infusion. | Drug | Phase 1b: Safety run-in, Phase 2: Dose expansion |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Up to approximately 2 years
AEs are assessed based on NCI CTCAE v6.0.
Maximum tolerate dose（MTD)
Time frame: Up to approximately 2 years
MTD of 7MW3711
Recommended Expansion Dose (RED)
Time frame: Up to approximately 2 years
RED of 7MW3711
9 secondary outcomes
Area Under the Concentration-time Curve (AUC)
Time frame: Up to approximately 2 years
Maximum concentration (Cmax)
Time frame: Up to approximately 2 years
Plasma clearance (CL)
Time frame: Up to approximately 2 years
Half-life (t1/2)
Time frame: Up to approximately 2 years
Time to peak drug concentration (Tmax)
Time frame: Up to approximately 2 years
Investigator-assessed progression-free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Investigator-assessed disease control rate (DCR)
Time frame: Up to approximately 2 years
Immunogenicity
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 7MW3711, JS207 and Cisplatin in people with Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shun Lu, Doctor (021-22200000 ext. 3121, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.