First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies

VelaVigo Bio Inc

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Participants With Advanced Solid Tumor Malignancies

Treatments

Drug: VBC101

Study type

Interventional

Funder types

Industry

Identifiers

NCT07136779

VBC101-01-01

Details and patient eligibility

About

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by 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 VBC101.

Enrollment

310 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 for which no standard treatment is available
3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
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
10. Participants must meet the minimum washout period requirements before the first dose of investigational drug

Exclusion criteria

1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.

2. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
3. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
4. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
5. 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.