230 Participants NeededMy employer runs this trial

VBC108 for Cancer

Recruiting at 11 trial locations
JY
Overseen ByJun Yan
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: VelaVigo Bio Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VBC108, a potential drug for individuals with advanced or metastatic solid tumors. Researchers aim to determine the optimal dose and assess its safety and effectiveness. The trial includes different groups testing various doses to identify the most suitable one for further study. Individuals diagnosed with an advanced solid tumor that cannot be surgically removed and have at least one measurable tumor may qualify for this trial. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that VBC108 is likely to be safe for humans?

Research has shown that VBC108, a new treatment, is currently being tested for safety in people with solid tumors. No direct studies on humans have yet provided clear safety information. As this trial is in its early stages, researchers are still assessing how well people can tolerate the treatment.

Early-phase trials primarily focus on testing safety and determining the right dose. Researchers are closely studying VBC108 to identify and manage any side effects. Although a complete safety profile is not yet available, ongoing research indicates that the treatment is being thoroughly tested. Participants in these trials will be carefully monitored by healthcare professionals.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about VBC108 because it represents a novel approach to cancer treatment. Unlike traditional therapies that might target specific cellular mechanisms or pathways, VBC108 is being tested across various dosage levels to identify the most effective and safest option for patients. This dose escalation strategy is particularly promising as it allows researchers to fine-tune the treatment, potentially leading to more personalized and effective cancer care. By exploring different dose levels and ultimately determining a recommended Phase 2 dose, VBC108 could offer a new, targeted avenue of treatment, which is particularly vital in the fight against cancer.

What evidence suggests that VBC108 might be an effective treatment for cancer?

Research has shown that VBC108 has a promising design that could benefit patients with certain solid tumors. This treatment targets tumors with CDH17, a protein present in some cancers. Laboratory studies suggest that VBC108 could be effective for gastric cancer patients, regardless of the presence of a protein called CLDN18.2 in their tumors. This indicates potential effectiveness even without a specific protein in the tumor. The dual-target approach, more complex than single-target methods, aims to attack cancer cells more broadly. Early evidence supports the potential of VBC108 in effectively treating solid tumors.12345

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors (cancers that form lumps in organs or tissues) who have tried standard treatments without success. Participants must be healthy enough overall to join and meet specific medical requirements set by the study team.

Inclusion Criteria

I have waited the required time since my last treatment before starting this study drug.
At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria
Life expectancy greater than 12 weeks
See 6 more

Exclusion Criteria

I have been treated with a CLDN18.2x CDH17 bispecific ADC before.
I have previously received CLDN18.2 CAR-T cell therapy.
I do not have any lingering moderate or severe side effects from past cancer treatments.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Phase 1 dose escalation using Bayesian optimal interval (BOIN) design to determine MTD and/or RP2D with potential backfill cohorts

21 days for DLT period

Phase 2a Treatment

Dose optimization followed by cohort expansion to confirm safety, tolerability, and efficacy of the selected RP2D

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post last dose

What Are the Treatments Tested in This Trial?

Interventions

  • VBC108

Trial Overview

The study is testing a new drug called VBC108, given in multiple doses, to find the safest dose and see how well it works against advanced solid tumors. The trial has two parts: first finding the best dose, then checking its safety and effectiveness.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: VBC108 Dose Level recommended Phase 2 dose (RP2D)Experimental Treatment1 Intervention
Group II: VBC108 Dose Level 5Experimental Treatment1 Intervention
Group III: VBC108 Dose Level 4Experimental Treatment1 Intervention
Group IV: VBC108 Dose Level 3Experimental Treatment1 Intervention
Group V: VBC108 Dose Level 2Experimental Treatment1 Intervention
Group VI: VBC108 Dose Level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VelaVigo Bio Inc

Lead Sponsor

Citations

Pancreatic Cancer - 胰腺癌- 药物 - 新药情报- 智慧芽

Population ageing was the major cause of the increase in deaths from pancreatic cancer in China, accounting for 45.89%. CONCLUSIONS The burden of pancreatic ...

头颈部鳞状细胞癌- 药物、靶点、专利 - 新药情报库

The presence of TLS within 100 µm of the tumor was associated with improved overall (p = 0.04) and progression-free survival (p = 0.03). A ...

全球肿瘤研发趋势全景分析:靶点格局、机构布局与AI技术融合

“Preclinical proof-of-concept data for VBC108 dual-target ADC presented at AACR 2025.” CStone News, April 2025. [31] Junshi Biosciences ...

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根据AACR 2025年会公布的研究统计数据,实体瘤研究占比高达89.14%,远超血液系统肿瘤(8.34%)及其他疾病类别(如代谢性疾病0.89%、免疫性疾病0.66%)。这 ...