MST-168 first-in-human test in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label, multicenter study evaluating MST-168, an investigational antibody-drug conjugate, in participants with advanced solid tumors. The trial will assess safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy. Eligible patients are adults with good performance status and adequate organ function, and the study includes careful monitoring for adverse events and dose-escalation to establish initial dosing. The study is conducted at Shanghai Chest Hospital with collaborators in Australia and Guangdong, under Mabsoft Therapeutics as the lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Changlong Liu
• Email: changlong.liu@mabsoftbio.com
• Phone: +86-15810213012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.