Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors

NCT07644650 | Not Yet Recruiting Phase 1

• 1 other identifier: MST-168-101
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief 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 advanced solid tumors. MST-168 is an investigational ADC.

Conditions

Neoplams

Keywords

advanced solid tumors; ADC

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicities (DLT)

  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.

  Through study completion, up to 25 months

Secondary Outcomes (16)

• PK parameters for MST-168, total anti-drug antibody and free payload: Tmax

  Day 1 to Day 8

• PK parameters for MST-168, total anti-drug antibody and free payload: Cmax

  Day 1 to Day 8

• PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t

  Day 1 to Day 8

• PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞

  Day 1 to Day 8

• PK parameters for MST-168, total anti-drug antibody and free payload: t1/2

  Day 1 to Day 8

Study Arms (6)

MST-168 initial dose level treatment Cohort

EXPERIMENTAL

MST-168 initial dose level

Biological: MST-168

MST-168 dose level 2 treatment Cohort

EXPERIMENTAL

MST-168 dose level 2

Biological: MST-168

MST-168 dose level 3 treatment Cohort

EXPERIMENTAL

MST-168 dose level 3

Biological: MST-168

MST-168 dose level 4 treatment Cohort

EXPERIMENTAL

MST-168 dose level 4

Biological: MST-168

MST-168 dose level 5 treatment Cohort

EXPERIMENTAL

MST-168 dose level 5

Biological: MST-168

MST-168 dose level 6 treatment Cohort

EXPERIMENTAL

MST-168 dose level 6, if needed

Biological: MST-168

Interventions

MST-168 BIOLOGICAL

MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mabsoft Therapeutics (Shanghai) Co., Ltd.: lead
• Mabsoft Therapeutics (Australia) Pty. Ltd.: collaborator
• Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.: collaborator

Central Study Contacts

Changlong Liu

CONTACT

+86-15810213012; changlong.liu@mabsoftbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 12, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 12, 2026

Record last verified: 2026-06