VBC101 for Cancer

Recruiting at 3 trial locations

Overseen By Chen Li

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: VelaVigo Bio Inc

Must not be taking: Corticosteroids, Anticonvulsants, others

Disqualifiers: Brain metastases, Interstitial lung diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VBC101 for individuals with advanced solid tumors that have recurred or worsened after standard treatments. The trial aims to determine the optimal dose, assess safety, and evaluate effectiveness in treating these cancers. It seeks participants with inoperable solid tumors who have not succeeded with other treatments. Participants must have measurable tumors and must have discontinued previous treatments for a specified period before starting the trial. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

Do I have to stop taking my current medications to join the trial?

The trial requires a minimum washout period (time without taking certain medications) before starting the study drug, but it doesn't specify which medications this applies to. It's best to discuss your current medications with the trial team to understand what changes might be needed.

Is there any evidence suggesting that VBC101 is likely to be safe for humans?

Research shows that VBC101 is a specialized treatment designed to target cancer cells directly. It attaches to specific proteins on these cells and delivers a drug to them. Earlier studies have shown VBC101's potential in fighting cancer. However, as this treatment remains in the early testing stages, detailed safety information for humans is not yet available.

The trial is in its initial phases, focusing on how well participants tolerate the treatment and identifying possible side effects. These early trials usually involve small groups to ensure safety. While some safety information is gathered, it may not be as comprehensive as in later trials. Participants might experience side effects, but these trials help determine the right dose to minimize them.

In summary, VBC101 is still undergoing safety testing in humans. Prospective participants should discuss the potential risks and benefits with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

VBC101 is unique because it represents a novel approach to treating cancer by targeting specific molecular pathways that are not addressed by traditional chemotherapy or immunotherapy. Unlike most cancer treatments that work by killing rapidly dividing cells or boosting the immune system to attack cancer cells, VBC101 employs a different mechanism of action, possibly involving a targeted pathway or a unique biomarker that makes it highly specific to cancer cells. Researchers are excited about this treatment because it has the potential to be more effective and less toxic, offering a more personalized and precise option for cancer patients.

What evidence suggests that VBC101 might be an effective treatment for cancer?

Research has shown that VBC101, the investigational treatment in this trial, could be promising for certain solid tumors. This treatment is a specialized medicine that targets tumor cells by recognizing two specific proteins, EGFR and cMet, commonly found on these cells. VBC101 delivers a potent cancer-fighting drug directly to tumors, minimizing harm to healthy cells. Early results suggest that targeting these proteins may effectively slow or halt tumor growth. Although more information is needed, this method provides a focused approach to attacking cancer cells. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for people with advanced solid tumors who haven't had success with other treatments. Participants must be adults, able to follow the study procedures and give informed consent. Specific criteria will determine if someone can join.

Inclusion Criteria

Participant or their legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure

I am 18 years old or older.

I am fully active or can carry out light work.

Exclusion Criteria

I don't have serious side effects from cancer treatment, except for hair loss, nerve issues, or skin color changes.

I have or might have a lung condition like pneumonia or fibrosis.

I have been treated with a drug targeting EGFR or cMet before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation and Backfill

Participants receive VBC101 with accelerated titration to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

Approximately 3-6 months

Phase 2a: Dose Optimization and Cohort Expansion

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

Approximately 1-2 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

• VBC101

Trial Overview VBC101 is being tested in this trial. It's a first-in-human study which means it's the first time this drug is given to people. The study has two parts: finding the maximum dose patients can take without serious side effects (Phase 1) and then confirming that dose's safety and looking at how well it works (Phase 2a).

How Is the Trial Designed?

Group I: Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion） Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

VelaVigo Bio Inc

Lead Sponsor

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/84/7_Supplement/LB043/742184/Abstract-LB043-VBC101-F11-An-innovative-EGFR-cMet

Abstract LB043: VBC101-F11: An innovative EGFR/cMet ... VBC101-F11 is a bispecific anti-EGFR/cMet ADC engineered to deliver clinically validated cytotoxic agents to tumor cells with a drug-to antibody ratio (DAR) of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07136779

NCT07136779 | First-in-Human Trial of VBC101 in ... 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, ...

3. researchgate.net researchgate.net/publication/379630834_Abstract_LB043_VBC101-F11_An_innovative_EGFRcMet_bispecific_antibody_drug_conjugate_ADC_targeting_key_oncogenic_drivers_in_solid_tumors

VBC101-F11: An innovative EGFR/cMet bispecific antibody ... VBC101-F11 is a bispecific anti-EGFR/cMet ADC engineered to deliver clinically validated cytotoxic agents to tumor cells with a drug-to antibody ratio (DAR) of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12562412/

Bispecific Antibody and Antibody-Drug Conjugate as Novel ... According to recent Surveillance, Epidemiology, and End Results (SEER) data, the 5-year relative survival rate of PDAC remains approximately ...

5. sigma.larvol.com sigma.larvol.com/product.php?e1=1032173&tab=newstrac

tilatamig samrotecan (AZD9592) News AZD9592 was effective in mCRC PDX models that did not respond to irinotecan-based treatment. Ongoing research is evaluating whether multiple doses of AZD9592 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11279420/

The Evolving Paradigm of Antibody–Drug Conjugates ... MMAE-conjugated VBC101-F11 displayed superior TGI over ABBV-399 in lung cancer cell line xenografts (3 mg/kg), and conjugation to a novel, undisclosed DNA ...