Phase 1/2a Open-Label Clinical Trial Evaluating VBC106, an FRα- and MSLN-Directed Bispecific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors

Study Identifier:
VBC106-01-01
CT.gov Identifier:
NCT07686068
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts BOIN design to identify the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC106.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Gastric
Liver
Solid Tumor
Mesothelioma
Endometrial
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • * - A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
  • * 1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
  • * 2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or standard therapies are not appropriate or not safe in the opinion of the Investigator or refused by the participant.
  • * 3. At least one measurable lesion as assessed according to RECIST v1.1 criteria for participants with non-pleural mesothelioma or other solid tumors and modified RECIST(mRECIST) for participants with malignant pleural mesothelioma.
  • * 4. Male or female adults (defined as ≥ 18 years of age)
  • * 5. ECOG performance status 0-1
  • * 6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
  • * 7. Life expectancy greater than 12 weeks
  • * 8. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
  • * 9. Adequate organ and bone marrow function The subject or their legal representative is willing and able to sign a written informed consent form (ICF) before any trial procedure is initiated.
  • Unresectable advanced/metastatic solid tumors confirmed by histology or cytology, recurrence or progression during or after standard systemic therapy, intolerance to standard therapy, or the investigator deems standard therapy unsuitable or unsafe, or the subject refuses treatment.
  • For subjects with malignant pleural mesothelioma, at least one measurable lesion should be assessed according to RECIST v1.1 criteria; for subjects with malignant pleural mesothelioma, at least one measurable lesion should be assessed according to the modified RECIST (mRECIST).
  • Male or female adult (≥18 years old)
  • (ECOG) Performance Status Score: 0 to 1
  • Within 28 days prior to enrollment, LVEF was measured to be ≥50% using ECHO or MUGA.
  • Life expectancy exceeding 12 weeks
  • Archived tumor tissue samples are available or new biopsy samples can be taken.
Exclusion criteria
  • 1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
  • 2. Known or suspected brain metastases, or spinal cord compression.
  • 3. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
  • 4. Has a history of underlying pulmonary disorder including.
  • 5. History of chronic, active, or hereditary corneal disease.
  • 6. Participant history of congestive heart failure (CHF) Class II-IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment. Any unrelieved grade 2 or higher toxicity resulting from prior antitumor therapy
  • Known or suspected brain metastases or spinal cord compression, unless the condition has been treated, is asymptomatic, and has been stable for at least four weeks prior to the first dose of the investigational drug, and there is no need to increase the dose of corticosteroids (equivalent to ≤10 mg/day prednisone) or anticonvulsants.
  • Those with a history of interstitial lung disease requiring oral or intravenous steroids (e.g., non-infectious interstitial pneumonia, lung inflammation, pulmonary fibrosis, and severe radiation pneumonitis), or currently suffering from interstitial lung disease, or suspected of having these diseases by imaging examinations at the time of screening.
  • A history of underlying lung disease, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, and other clinically significant lung damage or requiring supplemental oxygen within 3 months prior to the start of the investigational drug, as well as any autoimmune disease, connective tissue disease, or inflammatory disease involving the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) and/or a previous total pneumonectomy (complete removal of the lungs).
  • A history of chronic, active, or hereditary corneal diseases, including but not limited to keratitis, corneal epithelial defects, corneal ulcers, corneal stromal opacities, or keratosis.
  • Subjects had a history of congestive heart failure (CHF) classified as New York Heart Association (NYHA) NYHA functional class II-IV or a history of serious arrhythmias requiring treatment.
  • Researchers determined that the patient had uncontrolled hypertension.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Jose Pacheco
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Gastric
Liver
Solid Tumor
Mesothelioma
Endometrial