NeoplamsPhase 1NCT07644650
Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
A Phase 1 study testing MST-168 in people with Neoplams, run by Mabsoft Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors. The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplams
- What is being tested?
- MST-168
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2026to 30 Jun 2030
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
- I2. Is at least 18 years of age at the time of signing the ICF.
- I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- I4. Life expectancy ≥ 12 weeks.
- I5. Has adequate organ function.
- I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168.
- I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously unstable brain or CNS metastases.
- E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
- E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- E4. Has known sensitivity to study intervention components or excipients.
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, 201203
Xiaomin Dr. Niu, MD, 021-22200000 ext. 12345, ar_tey@hotmail.com
About this study
Official title: A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
- Conditions
- Neoplams
- Being tested
- MST-168
- Keywords
- advanced solid tumors, ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MST-168Biological
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
| Study group | Role | What they receive |
|---|---|---|
| MST-168 initial dose level treatment Cohort | Experimental | MST-168 initial dose level Receives: Biological: MST-168 |
| MST-168 dose level 2 treatment Cohort | Experimental | MST-168 dose level 2 Receives: Biological: MST-168 |
| MST-168 dose level 3 treatment Cohort | Experimental | MST-168 dose level 3 Receives: Biological: MST-168 |
| MST-168 dose level 4 treatment Cohort | Experimental | MST-168 dose level 4 Receives: Biological: MST-168 |
| MST-168 dose level 5 treatment Cohort | Experimental | MST-168 dose level 5 Receives: Biological: MST-168 |
| MST-168 dose level 6 treatment Cohort | Experimental | MST-168 dose level 6, if needed Receives: Biological: MST-168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLT)
Measured: Day 1 - Day 28
Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
Measured: Through study completion, up to 25 months
Secondary outcomes (16)
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Measured: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Measured: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Measured: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Measured: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
Measured: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: CL
Measured: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: Vss
Measured: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
Measured: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
Measured: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
Measured: Through study completion, up to 24 months
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
Measured: Through study completion, up to 24 months
Biomarkers: cytokines/chemokines and immune cell phenotypes
Measured: Through study completion, up to 24 months
Objective response rate (ORR) based on RECIST v1.1.
Measured: Through study completion, up to 24 months
Duration of response (DoR) based on RECIST v1.1.
Measured: Through study completion, up to 24 months
Progression-free survival (PFS) based on RECIST v1.1.
Measured: Through study completion, up to 24 months
Disease control rate (DCR) based on RECIST v1.1.
Measured: Through study completion, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start26 Oct 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplamsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabsoft Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mabsoft Therapeutics (Australia) Pty. Ltd., Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644650
- Sponsor's protocol ID
- MST-168-101
- Status last verified
- Oct 2026
- First submitted
- 31 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors
- ClinicalTrials.gov ID
- NCT07644650
- Acronym / sponsor ID
- MST-168-101
- Conditions
- Neoplams
- Keywords
- advanced solid tumors, ADC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Mabsoft Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Mabsoft Therapeutics (Australia) Pty. Ltd., Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 12 Jun 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.
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MST-168 initial dose level treatment Cohort | Experimental | Biological: MST-168MST-168 initial dose level |
| MST-168 dose level 2 treatment Cohort | Experimental | Biological: MST-168MST-168 dose level 2 |
| MST-168 dose level 3 treatment Cohort | Experimental | Biological: MST-168MST-168 dose level 3 |
| MST-168 dose level 4 treatment Cohort | Experimental | Biological: MST-168MST-168 dose level 4 |
| MST-168 dose level 5 treatment Cohort | Experimental | Biological: MST-168MST-168 dose level 5 |
| MST-168 dose level 6 treatment Cohort | Experimental | Biological: MST-168MST-168 dose level 6, if needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
- I2. Is at least 18 years of age at the time of signing the ICF.
- I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- I4. Life expectancy ≥ 12 weeks.
Key exclusion criteria (5 listed)
- Participants are excluded from the study if any of the following criteria apply:
- E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously unstable brain or CNS metastases.
- E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
- E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- E4. Has known sensitivity to study intervention components or excipients.
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 |
|---|---|---|
| MST-168MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics. | Biological | MST-168 dose level 2 treatment Cohort, MST-168 dose level 3 treatment Cohort, MST-168 dose level 4 treatment Cohort, MST-168 dose level 5 treatment Cohort, MST-168 dose level 6 treatment Cohort, MST-168 initial dose level treatment Cohort |
Primary outcome
Incidence of dose-limiting toxicities (DLT)
Time frame: Day 1 - Day 28
Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
Time frame: Through study completion, up to 25 months
16 secondary outcomes
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: CL
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: Vss
Time frame: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
Time frame: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
Time frame: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
Time frame: Through study completion, up to 24 months
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
Time frame: Through study completion, up to 24 months
Biomarkers: cytokines/chemokines and immune cell phenotypes
Time frame: Through study completion, up to 24 months
Objective response rate (ORR) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months
Duration of response (DoR) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months
Progression-free survival (PFS) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months
Disease control rate (DCR) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 study testing MST-168 in people with Neoplams, run by Mabsoft Therapeutics (Shanghai) 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 8 inclusion and 5 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 28 Oct 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 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.
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 Changlong Liu (+86-15810213012, changlong.liu@mabsoftbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLT) (time frame: Day 1 - Day 28). The study lists 2 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 28 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.