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Clinical Trials in China / NCT06349408
Recruiting Phase 1

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

NCT06349408 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Phase 1
Started
2025-01-10
Last updated
2025-01-27

Condition(s) studied

Locally Advanced Solid Tumor

Investigational drug(s) / intervention(s)

IBI3001

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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. -

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Wollongong Public Wollongong New South Wales Recruiting
Cancer Research SA Adelaide South Australia Recruiting
Chinese PLA General Hospital Beijing Beijing Municipality Not Yet Recruiting
Shanghai East Hospital Shanghai Shanghai Municipality Not Yet Recruiting
The First Affiliated Hospital of zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting

More Innovent Biologics (Suzhou) Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06349408 on ClinicalTrials.gov ↗ ← All trials in China