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

ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVelaVigo Bio Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VBC117

    Drug

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

Treatment groups

260 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: VBC117 Dose Level 1Experimental treatment 1 intervention
Group B: VBC117 Dose Level 2Experimental treatment 1 intervention
Group C: VBC117 Dose Level 3Experimental treatment 1 intervention
Group D: VBC117 Dose Level 4Experimental treatment 1 intervention
Group E: VBC117 Dose Level 5Experimental treatment 1 intervention
Group F: VBC117 Dose Level RP2DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of AEs

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

Time frame
From time of Informed Consent to 30 days post last dose of VBC117
2

Incidence of DLTs

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

Time frame
From time of first dose of VBC117 to end of DLT period (approximately 21 days)
3

Incidence of SAEs

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

Time frame
From time of Informed Consent to 30 days post last dose of VBC117
4

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VelaVigo Bio Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: