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

NCT06349408 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CIBI3001A101
• Study Type: interventional
• Target: 250
• Locations: 3 countries
• Sites: 27

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

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

  Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria

  24 months

• Number of subjects with clinically significant changes in physical examination results

  Clinically significant abnormal physical examination findings reported by the investigator.

  24 months

• Number of subjects with clinically significant changes in vital signs

  Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

  24 months

• MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)

  Dose limiting toxicity (DLT) to establish MTD or RP2D

  24 months

Secondary Outcomes (13)

• Plasma concentration (Cmax) of IBI3001

  24 months

• Area under the curve (AUC) of IBI3001

  24 months

• Time to maximum concentration (Tmax) of IBI3001

  24 months

• Clearance (CL) of IBI3001

  24 months

• Volume of distribution (V) of IBI3001

  24 months

Study Arms (1)

Open-label: IBI3001 monotherapy

EXPERIMENTAL

Drug: IBI3001

Interventions

IBI3001 DRUG

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)

Open-label: IBI3001 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants ≥ 18 years old;
• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
• Has an anticipated life expectancy of ≥ 12 weeks;
• Adequate bone marrow and organ function:
• 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.
• 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.

You may not qualify if:

• 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;
• 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;
• Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
• Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
• Known symptomatic central nervous system (CNS) metastases.
• History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
• History of endotracheal or gastrointestinal stent implantation;
• Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
• Esophageal or gastric varices requiring immediate intervention;
• Not eligible to participate in this study at the discretion of the investigator;
• Do not have adequate treatment washout period before study drug administration. -

Sponsors & Collaborators

• Fortvita Biologics (USA)Inc.: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (27)

START Center for Cancer Research

Los Angeles, California, 90025, United States

RECRUITING

START Center for Cancer Research

East Brunswick, New Jersey, 08816, United States

RECRUITING

NEXT Oncology

Dallas, Texas, 75039, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

ACTIVE NOT RECRUITING

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, 5000, Australia

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

First Affiliated Hospital, Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

The Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Anyang Cancer Hospital

Anyang, Henan, 455100, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

Nanjing, Jiangsu, 210029, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Fortvita Biologics CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CN (21); US (4)