First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
Recruiting
Phase 1
Phase 2
Interventional Study
Participants With Advanced Solid Tumor Malignancies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 310 (estimated)
- Sponsor
- VelaVigo Bio Inc · Industry
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About This Trial
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, followed by BOIN design to identify the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the se…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
* 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\. Hi…
Contacts