IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

NCT06974812 | Recruiting Phase 1

• 1 other identifier: CIBI3014A101
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Unresectable Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (6)

• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

  Number ofparticipants with adverse events (AEs)

  2 years after LPI

• Dose limiting toxicity (DLT) of IBI3014 in Phase 1 dose escalation

  The occurance of Dose limiting toxicity (DLT) per protocol to establish MTD or RDEs

  21 days after LPI

• ORR per RECIST v1.1 in Phase 1 dose expansion and Phase 2 dose optimization

  The investigator assessed ORR per RECIST v1.1

  2 years after LPI

• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

  Number ofparticipants with abnormal laboratorytests results

  2 years after LPI

• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

  Number ofparticipants with abnormal physical examination findings

  2 years after LPI

• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

  Number ofparticipants with abnormal vital signs

  2 years after LPI

Secondary Outcomes (7)

• Efficacy of IBI3014

  2 years after LPI

• PK profile of IBI3014

  2 years after LPI

• Incidence and characterization of anti-IBI3014 antibodies

  2 years after LPI

• PK profile of IBI3014

  2 years after LPI

• PK profile of IBI3014

  2 years after LPI

Study Arms (1)

IBI3014

EXPERIMENTAL

IBI3014 will be dosed until disease progression, toxicity intolerance, starting of new systemic anti-cancer treatment, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaching the maximum of 24 months, whichever occurs first.

Drug: IBI3014

Interventions

IBI3014 DRUG

12 mg/kg D1 IV Q3W

IBI3014

Eligibility Criteria

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

You may qualify if:

• 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;
• Male or female participants ≥ 18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
• Anticipated life expectancy of ≥ 12 weeks;
• 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).
• Adequate bone marrow and organ function:
• Has at least 1 measurable lesion per RECIST v1.1(at least 1 evaluable lesion for dose participants in dose escalation part);
• Not a candidate for curable surgical resection or radical chemoradiation;

You may not qualify if:

• Drugs and other treatments to be excluded;
• 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;
• 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.
• Allergic or hypersensitive to other monoclonal antibodies and/or Camptothecin Derivative based therapy, or any ingredients of IBI3014;
• 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;
• 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;
• Participants with a clinically significant (CS) cardiovascular disease or condition;
• Participants with a significant gastrointestinal disease or condition,
• 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;
• Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
• Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;
• Significant malnutrition, such as the need for intravenous fluids; Malnutrition corrected for more than 4 weeks prior to the first administration of study drug is allowed;
• Tumor invasion of surrounding important structures (such as mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula;
• Uncontrolled or clinically significant infections
• History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (3)

Fujian cancer hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Wei Zhang

CONTACT

15005136320; wei.zhang02@innoventbio.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 23, 2025
• First Posted: May 16, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (3)