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Advanced Solid TumorPhase 1/2NCT06008379

A Study of 7MW3711 in Subjects With Advanced Solid Tumors

A Phase 1/2 study testing 7MW3711 for injection in people with Advanced Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
7MW3711 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
5 sitesChina
Study dates
28 Aug 2023to 30 Jan 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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.
  • Part 1: 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; part 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors having progressed after at least one line of standard systermic therapy or intolerate 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

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 V5.0.
  • 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 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

Trial locations and contacts

5 sites in 1 country.

Sun Lu, Doctor contact

021-22200000*3121

shun-lu@hotmail.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Yongzhong Luo

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Zhengbo Song, Doctor, songzb@zjcc.org.cn

    Not yet recruiting

  • The Lung Cancer Center of Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 2000043

    Sun Lu, Doctor, 021-22200000*3121, shun-lu@hotmail.com

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

    Liang Han

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Qiming Wang

    Not yet recruiting

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
7MW3711 for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7MW3711 for injectionDrug

    IV administration of 7MW3711, Q3W, 3 weeks a cycle

  • 7MW3711 for injectionDrug

    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

Study groups in NCT06008379
Study groupRoleWhat they receive
dose escalation and dose expansionExperimentalall subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion
Receives: Drug: 7MW3711 for injection
cohort expansionExperimentalall subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion
Receives: Drug: 7MW3711 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: approximately up to 16 cycles, 21 days a cycle

  2. Identification of the MTD and /or RP2D of 7MW3711(part 1)

    Measured: from Day1 to Day21 in cycle1 of part 1

  3. 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 completeresponse (CR) or partial response (PR)

    Measured: approximately up to 2 years

Secondary outcomes (10)

  1. evaluation of PK parameters of 7MW3711

    Maximum observed concentration(Cmax)

    Measured: approximately up to 2 years

  2. evaluation of PK parameters of 7MW3711

    the time to Cmax(tmax)

    Measured: approximately up to 2 years

  3. evaluation of PK parameters of 7MW3711

    half-live(t1/2)

    Measured: approximately up to 2 years

  4. evaluation of PK parameters of 7MW3711

    Area under the concentration-time curve(AUC)

    Measured: approximately up to 2 years

  5. overall response rate (ORR) (part1)

    ORR:defined as the proportion of patients who achieved a best overall response of completeresponse (CR) or partial response (PR) based on RECIST version 1.1.

    Measured: approximately up to 1 years

  6. disease control rate(DCR)

    DCR:defined as the proportion of subjects with CR, PR, and SD based on RECIST 1.1 criteria

    Measured: approximately up to 2 years

  7. progression-free survival(PFS)

    PFS:defined as time from the date of first administration to the date of first documented disease progression based on RECIST 1.1 criteria, or death due to any cause, whichever occurs first

    Measured: approximately up to 2 years

  8. time to response (TTR)

    TTR:defined as time from the date of first administration to the date of first documented CR or PR

    Measured: approximately up to 2 years

  9. evaluation of the immunogenicity of 7MW3711

    Frequency and percentage of subjects with positive anti-drug antibody after being treated by 7MW3711.

    Measured: approximately up to 2 years

  10. 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.

    Measured: approximately up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start28 Aug 2023
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion30 Jan 2026 (estimated)

Resources

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
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008379
Sponsor's protocol ID
7MW3711-2023-CP102
Status last verified
Sep 2023
First submitted
7 Aug 2023
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 7MW3711 for injection in people with Advanced Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 5 sites 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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sun Lu, Doctor (021-22200000*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?

evaluation of the incidence of adverse events (AEs) (part 1) (time frame: approximately up to 16 cycles, 21 days a cycle). 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?

On the ClinicalTrials.gov record for NCT06008379.

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 13 Sep 2023.

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