VBC103 treatment for advanced malignant 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 first-in-human, multicenter, open-label, multi-dose Phase I/IIa study of the single agent VBC103 designed to define safety, tolerability, and the maximum tolerated dose or recommended Phase II dose, characterize pharmacokinetics, and obtain early signs of activity. Adult patients with unresectable advanced or metastatic solid tumors that have recurred or progressed after standard systemic therapy (or who lack or are intolerant to standard options) and who have at least one measurable lesion by RECIST v1.1 are eligible. Key baseline requirements include ECOG performance status 0–1, left ventricular ejection fraction ≥50%, life expectancy >12 weeks, and availability of tumor tissue or willingness to undergo biopsy. Major exclusions include unresolved ≥Grade 2 toxicity from prior therapy, active keratitis or corneal ulcer, and a history of interstitial lung disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1.The subject or their legal representative is willing and able to sign a written ICF before initiating any study procedures.
* 2.Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has recurred or progressed during or after standard systemic therapy, or is intolerant to standard therapy, or lacks standard treatment options (applicable only to Phase I and Phase IIa Cohort 5).
* 3.At least one measurable lesion as assessed by the investigator per RECIST v1.1.
* 4.Adult male or female (defined as ≥18 years of age)
* 5.ECOG performance status score of 0-1.
* 6.LVEF ≥50% as measured by ECHO or MUGA within 28 days prior to enrollment.
* 7.Life expectancy exceeding 12 weeks.
* 8.Availability of archived tumor tissue samples or willingness to undergo biopsy sampling.

Exclusion Criteria:

* 1.Any unresolved ≥Grade 2 toxicity from prior anticancer therapy.
* 2.Known active keratitis or corneal ulcer.
* 3.History of interstitial lung disease (e.g., non-infectious interstitial pneumonia, pneumonitis,pulmonary fibrosis, or severe radiation pneumonitis), current interstitial lung disease, or suspected interstitial lung disease based on imaging during the screening period.
* 4.History of underlying pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to the start of investigational product, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, and other clinically significant pulmonary impairment or requiring supplemental oxygen, as well as any autoimmune, connective tissue, or inflammatory disease involving the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) and/or prior pneumonectomy (complete resection).

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jian Zhang
• Email: syner2000@163.com
• Phone: 021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-in-human testing of VBC101 in advanced solid tumors

  This trial will try the experimental drug VBC101 in adults with advanced solid tumors that have progressed after standard treatments.

  Recruiting at 5 sites Phase 1/2 VelaVigo Bio Inc · Grand Rapids, Michigan and 4 other locations · NCT07136779

• First-in-Human Trial of a VBC108 Treatment for Advanced Solid Tumors

  This early-stage trial tests VBC108 in adults with unresectable or metastatic solid tumors to see if it is safe and tolerable and to get a sense of how well it might work.

  Recruiting at 5 sites Phase 1/2 VelaVigo Bio Inc · Duarte, California and 11 other locations · NCT07700160

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.