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NCT05548634 · ClinicalTrials.gov registry record · Phase 1

A Study of TAVO412 in Patients with Cancer

A Phase 1 study of Cancer, sponsored by Tavotek Biotherapeutics.

Active
Registry status
Phase 1
Development phase
50
Enrollment target
1
Study location

NCT05548634: Active Phase 1 study of Cancer, sponsored by Tavotek Biotherapeutics.

NCT05548634 is a Phase 1 study of Cancer that is active but no longer recruiting, run by Tavotek Biotherapeutics. The registered enrollment target is 50 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05548634, a Phase 1 study of Cancer, is active but no longer recruiting, sponsored by Tavotek Biotherapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of TAVO412. Part 1 will utilize a standard 3 + 3 design to determine the MTD/RP2D of TAVO412 in subjects with advanced or metastatic solid tumors who progressed on prior approved standard of care therapy. Part 2 will further evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacologic activity of TAVO412 in a new set of subjects with advanced or metastatic gastric cancer, non-small cell lung cancer (NSCLC), or subjects of other solid tumor types with best clinical responses (e.g., CR \> PR \> SD) from Part 1 that progressed on prior approved standard of care therapy.

Primary Outcome

According to the frequency, duration, and severity of Adverse Events (AEs). The Dose Limiting Toxicity (DLT) is based on drug related adverse events and includes unacceptable hematologic toxicity, non-hematologic toxicity of Grade 3 or higher, or elevations in hepatic enzymes suggestive of drug-induced liver injury. The Common Terminology Criteria for Adverse Events (CTCAE) v5.0 has a minimum value of Grade 1, or mild, and a maximum value of Grade 4, Life-threatening; pressor or ventilatory sup

Conditions Studied

Interventions

  • DRUG TAVO412

Study Locations (1)

New York

  • Tisch Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-05-08
Est. Completion 2026-06-01
Phase Phase 1
Tavotek Biotherapeutics

2 total trials

What the registry record for NCT05548634 still lists

NCT05548634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which TAVO412 is the first listed.

NCT05548634 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT05548634 about?

NCT05548634 is a clinical study titled "A Study of TAVO412 in Patients with Cancer". TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of TAVO412. Part 1 will utilize a standard 3 + 3 design to determine the MTD/RP2D of TAVO412 in subjects with advanced or metastatic...

What is the current status of trial NCT05548634?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2023-05-08. Estimated completion is 2026-06-01.

What conditions does trial NCT05548634 study?

This clinical trial studies the following conditions: Cancer.

What interventions are being tested in trial NCT05548634?

The interventions under investigation include: TAVO412 (DRUG).

Who is sponsoring clinical trial NCT05548634?

This trial is sponsored by Tavotek Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05548634 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05548634's enrollment target sits among peer trials

50 422nd of 615 higher than 179 of 615 other Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05548634, the US trial registry maintained by the National Library of Medicine. NCT05548634 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.