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IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study of IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

NCT06974812•Innovent Biologics (Suzhou) Co. Ltd.

Summary

This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1.Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
•2.Male or female participants ≥ 18 years old;
•3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
•4.Anticipated life expectancy of ≥ 12 weeks;
•5.Participants, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug).
•6.Adequate bone marrow and organ function:
•7.Has at least 1 measurable lesion per RECIST v1.1(at least 1 evaluable lesion for dose participants in dose escalation part);
•8.Not a candidate for curable surgical resection or radical chemoradiation;

Exclusion Criteria

•1.Drugs and other treatments to be excluded;
•2.Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigators' opinion) prior to first administration of the study drug;
•3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is severe and influence the safety assessment of participants.
•4.Allergic or hypersensitive to other monoclonal antibodies and/or Camptothecin Derivative based therapy, or any ingredients of IBI3014;
•5.Known symptomatic central nervous system (CNS) metastases. The following conditions could be considered enrollment: Participants with asymptomatic CNS metastases (which means no neural system syndromes, no need of corticosteroids treatment and diameter of metastases ≤ 1.5cm) or confirmed stable status according to Investigators' opinion after treatment, No midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord metastasis; and stable status for at least 4 weeks without new or enlarged metastases definitively confirmed by clinical evidence, and withdrawal of corticosteroids or anticonvulsant for at least 2 weeks prior to the first administration of study drug;
•6.History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g. Interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or who are suspected to have these diseases by imaging at screening period;
•7.Participants with a clinically significant (CS) cardiovascular disease or condition;
•8.Participants with a significant gastrointestinal disease or condition,
•9.Participants with biliary obstruction. Unless the blockage is treated locally, such as endoscopic stenting or percutaneous liver puncture and drainage, the total bilirubin is reduced below 1.5 times ULN;
•10.Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
+10 more criteria

Locations (3)

Fujian cancer hospital

Fuzhou, Fujian, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 18, 2025

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2027

Last Updated

January 29, 2026

Enrollment

250

ESTIMATED participants

Conditions

Unresectable Locally Advanced or Metastatic Solid Tumors

Interventions

IBI3014

DRUG

IBI3014

DRUG

IBI3014

DRUG

IBI3014

DRUG

IBI3014

DRUG

IBI3014

DRUG

IBI3014

DRUG

IBI3014

DRUG

Contacts

Wei Zhang

CONTACT

15005136320 wei.zhang02@innoventbio.com