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Recruiting Phase 1 Interventional

IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

ClinicalTrials.gov ID: NCT06349408

Public ClinicalTrials.gov record NCT06349408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 26, 2026, 12:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

Study identification

NCT ID
NCT06349408
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Fortvita Biologics (USA)Inc.
Industry
Enrollment
250 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 9, 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027
Last update posted
Sep 24, 2026

2025 – 2027

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
START Center for Cancer Research Los Angeles California 90025 Recruiting
START Center for Cancer Research East Brunswick New Jersey 08816 Recruiting
NEXT Oncology Dallas Texas 75039 Recruiting
Virginia Cancer Specialists Fairfax Virginia 22031 Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06349408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 24, 2026 · Synced Sep 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06349408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →