Phase I/IIa Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors

Study Identifier:
VBC108-01-01
CT.gov Identifier:
NCT07700160
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 uses Bayesian optimal interval (BOIN) design to escalate and determine 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 VBC108.

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)
Pancreas
Gastric
Liver
Solid Tumor
Digestive & Intestinal
Anal
Gallbladder
Bile Duct
Small Intestine
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
Drug: Single-arm treatment with VBC108 for Injection, a lyophilized powder supplied as 100 mg per bottle. VBC108 is administered by intravenous infusion at the dosage specified in the protocol. Treatment continues until disease progression, intolerable toxicity, or no clinical benefit. No comparator treatment is reported.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • 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 .
  • 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
  • 4. Male or female adults (defined as ≥ 18 years of age).
  • 5. ECOG performance status 0-1.
  • 6. Life expectancy greater than 12 weeks.
  • 7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
  • 8. Adequate organ and bone marrow function.
  • 9. Participants must meet the minimum washout period requirements before the first dose of investigational drug. 1 The trial participant or their legally authorized representative is willing and able to provide a written ICF prior to the commencement of any trial procedure.
  • 2 Adult males or females (≥18 years old)
  • 3 Unresectable advanced/metastatic gastrointestinal tumors confirmed by histology or cytology, and meeting any of the following criteria: recurrence or progression during or after standard systemic therapy, intolerance to standard therapy, investigator's opinion that standard therapy is inapplicable/unsafe, or trial participant's refusal of standard therapy.
  • 4 Researchers assessed the presence of at least one measurable lesion using RECIST v1.1.
  • 5 Within 28 days prior to enrollment, LVEF was measured to be ≥50% using ECHO or MUGA.
  • 6 ECOG fitness status score is 0-1.
  • 7 Archived tumor tissue samples or biopsy samples can be obtained.
  • 8 Expected survival > 12 weeks
  • 9 Organs and bone marrow function fully
  • 10 Contraceptive practices used by both male and female trial participants complied with local clinical trial participant contraceptive management regulations.
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. Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.
  • 4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
  • 5. Prior treatment with CLDN18.2 targeting CAR-T. 1 Any unrelieved grade 2 or higher toxicity resulting from prior anticancer treatment
  • 2 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.
  • 3 Those with a history of interstitial lung disease (such as non-infectious interstitial pneumonia, pneumonia, pulmonary fibrosis, and severe radiation pneumonitis), or currently suffering from interstitial lung disease, or whose imaging examinations during the screening period suggest the presence of the above-mentioned diseases.
  • 4 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 resection).
  • 5 Documented unrelieved gastric outlet obstruction or persistent/recurrent vomiting
  • 6 Digestive system diseases that may cause bleeding, perforation, jaundice, or gastrointestinal obstruction
  • 7 A history of congestive heart failure, or a serious arrhythmia requiring treatment.
  • 8 Researchers judged it to be uncontrolled hypertension.
  • 9 A history of other primary malignancies within ≤2 years prior to starting the study drug, excluding adequately treated cancers (such as basal cell carcinoma of the skin, squamous cell carcinoma, or cervical carcinoma in situ).
  • 10 Uncontrolled complications
  • 11 Exclusion of participants from active viral hepatitis trials
  • 12 Known HIV infection
  • 13 Known allergy to the investigational drug or any of its excipients
  • 14 Researchers determined that they were unable or unwilling to comply with the trial procedures.
  • 15 Any condition or illness that the researcher or medical monitor believes may affect the safety of trial participants or interfere with the evaluation of drug safety.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Sreenivasa Chandana
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Pancreas
Gastric
Liver
Solid Tumor
Digestive & Intestinal
Anal
Gallbladder
Bile Duct
Small Intestine