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Not yet recruiting NCT07644650

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

Phase I Interventional Neoplams

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MST-168.
Who it may be relevant to
Registry conditions: Neoplams. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07644650 · MST-168-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗