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

ClinicalTrials.gov ID: NCT06349408

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ClinicalTrials.gov public records Last synced Nov 13, 2026, 6:30 PM EST

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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

Conditions

Locally Advanced Solid Tumor

Interventions

IBI3001 Drug

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 10, 2025 (Actual)
Primary completion: Dec 31, 2026 (Estimated)
Completion: Dec 31, 2027 (Estimated)
Last update posted: Sep 25, 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 25, 2026 · Synced Nov 13, 2026