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

NCT07772934 | Not Yet Recruiting Phase 1

• 1 other identifier: VBC117-01-01
• Study Type: interventional
• Target: 260
• Locations: 2 countries
• Sites: 12

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; VBC117; Phase 1; Phase 2a; Dose Escalation

Outcome Measures

Primary Outcomes (5)

• Incidence of AEs

  Number of patients with Adverse Events（AEs）by system organ class and preferred term

  From time of Informed Consent to 30 days post last dose of VBC117

• Incidence of DLTs

  Incidence of dose-limiting toxicities (DLT) as defined in the protocol

  From time of first dose of VBC117 to end of DLT period (approximately 21 days)

• Incidence of SAEs

  Number of patients with Serious Adverse Events(SAEs)by system organ class and preferred term

  From time of Informed Consent to 30 days post last dose of VBC117

• Incidence of TEAE leading to dose modification or discontinuation

  Number of patients with treatment-emergent adverse event (TEAE) leading to dose modification or discontinuation by system organ class and preferred term

  From time of Informed Consent to 30 days post last dose of VBC117

• objective response rate (ORR)

  The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours

  From first dose of VBC117 to disease progression or death, up to approximately 2 years

Study Arms (6)

VBC117 Dose Level 1

EXPERIMENTAL

Phase 1 dose escalation and backfill: VBC117 at Dose Level 1

Drug: VBC117

VBC117 Dose Level 2

EXPERIMENTAL

Phase 1 dose escalation and backfill: VBC117 at Dose Level 2

Drug: VBC117

VBC117 Dose Level 3

EXPERIMENTAL

Phase 1 dose escalation and backfill: VBC117 at Dose Level 3

Drug: VBC117

VBC117 Dose Level 4

EXPERIMENTAL

Phase 1 dose escalation and backfill: VBC117 at Dose Level 4

Drug: VBC117

VBC117 Dose Level 5

EXPERIMENTAL

Phase 1 dose escalation and backfill: VBC117 at Dose Level 5

Drug: VBC117

VBC117 Dose Level RP2D

EXPERIMENTAL

Phase 2a expansion cohort: VBC117 at RP2D across tumor-specific cohorts

Drug: VBC117

Interventions

VBC117 DRUG

VBC117 is a epidermal growth factor receptor (EGFR)x Cadherin-17 (CDH17) bispecific antibody-drug conjugate (ADC).

VBC117 Dose Level 1; VBC117 Dose Level 2; VBC117 Dose Level 3; VBC117 Dose Level 4; VBC117 Dose Level 5; VBC117 Dose Level RP2D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
• Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
• At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
• Male or female adults (defined as ≥ 18 years of age).
• ECOG performance status 0-1.
• Life expectancy greater than 12 weeks.
• Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
• Adequate organ and bone marrow function.

You may not qualify if:

• Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
• Known or suspected brain metastases, or spinal cord compression.
• Prior treatment with an ADC targeting EGFR x CDH17 bispecific ADC.
• Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
• 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.

Sponsors & Collaborators

• VelaVigo Bio Inc: lead

Study Sites (12)

Macquarie University

Randwick, New South Wales, 2031, Australia

Location

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

Cancer Care Wollongong

Wollongong, New South Wales, 2500, Australia

Location

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, Hangzhou, 310009, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Liaoning Cancer Hospital & Institute

Shengyang, Liaoning, 110042, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Shanghai GoBroad Cancer Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study consists of two parts: Phase 1, which employs a sequential BOIN dose-escalation design to evaluate safety and determine the RP2D, and Phase 2a, a parallel-group expansion cohort to assess preliminary anti-tumor activity at the RP2D.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): February 27, 2029
• Study Completion (Estimated): May 28, 2029
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

AU (4); CN (8)