VBC117First-in-Human Trial of VBC117 in Participants With Advanced Malignant Solid Tumors

Phase 1/2a Open-label Clinical Trial Evaluating VBC117, an EGFR and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors

Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.

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.

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 EGFR x CDH17 bispecific ADC.
4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
5. Has a medical history of interstitial lung diseases or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.