Recruiting
Phase 1

IBI3001

Sponsor:

Fortvita Biologics (USA)Inc.

Code:

NCT06349408

Conditions

Locally Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IBI3001

Study Details

Brief summary:

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.

Conditions

Locally Advanced Solid Tumor

Study ID

NCT06349408

Start date

Jan 10, 2025

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Male or female participants ≥ 18 years old;
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Has an anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function:
5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Key Exclusion Criteria:

1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
5. Known symptomatic central nervous system (CNS) metastases.
6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
7. History of endotracheal or gastrointestinal stent implantation;
8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
9. Esophageal or gastric varices requiring immediate intervention;
10. Not eligible to participate in this study at the discretion of the investigator;
11. Do not have adequate treatment washout period before study drug administration. -

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label: IBI3001 monotherapy

Interventions

IBI3001

The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study.

IBI3001 is proposed to be administered by intravenous infusion (IV)

Primary outcome measure

  • Number of subjects with adverse events [ Time Frame: 24 months ]
  • Number of subjects with clinically significant changes in physical examination results [ Time Frame: 24 months ]
  • Number of subjects with clinically significant changes in vital signs [ Time Frame: 24 months ]
  • MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Fortvita Biologics CT.gov Call Center

650-370-0985ct.govNotifications@fortvitabio.com

Locations

START Center for Cancer Research

Recruiting

Los Angeles, California, United States, 90025

Contacts

Fortvita Biologics CT.gov Call Center

650-370-0985ct.govNotifications@fortvitabio.com

START Center for Cancer Research

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Fortvita Biologics CT.gov Call Center

650-370-0985ct.govNotifications@fortvitabio.com

NEXT Oncology

Recruiting

Dallas, Texas, United States, 75039

Contacts

Fortvita Biologics CT.gov Call Center

650-370-0985ct.govNotifications@fortvitabio.com

More Information

Sponsor

Fortvita Biologics (USA)Inc.

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Fortvita Biologics (USA)Inc. on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.