IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

Official title

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

Overview

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.

Interventions

• Drug IBI3014
  12 mg/kg D1 IV Q3W
• Drug IBI3014
  6 mg/kg D1 IV Q3W
• Drug IBI3014
  1 mg/kg D1 IV Q3W
• Drug IBI3014
  15 mg/kg D1 IV Q3W
• Drug IBI3014
  9 mg/kg D1 IV Q3W
• Drug IBI3014
  3 mg/kg D1 IV Q3W
• Drug IBI3014
  20 mg/kg D1 IV Q3W
• Drug IBI3014
  18 mg/kg D1 IV Q3W

Primary outcome measures

• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization [Time frame: 2 years after LPI]
• Dose limiting toxicity (DLT) of IBI3014 in Phase 1 dose escalation [Time frame: 21 days after LPI]
• ORR per RECIST v1.1 in Phase 1 dose expansion and Phase 2 dose optimization [Time frame: 2 years after LPI]
• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization [Time frame: 2 years after LPI]
• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization [Time frame: 2 years after LPI]
• The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization [Time frame: 2 years after LPI]

Secondary outcome measures (7)

• Efficacy of IBI3014 [Time frame: 2 years after LPI]
• PK profile of IBI3014 [Time frame: 2 years after LPI]
• Incidence and characterization of anti-IBI3014 antibodies [Time frame: 2 years after LPI]
• PK profile of IBI3014 [Time frame: 2 years after LPI]
• PK profile of IBI3014 [Time frame: 2 years after LPI]
• PK profile of IBI3014 [Time frame: 2 years after LPI]
• PK profile of IBI3014 [Time frame: 2 years after LPI]

Eligibility criteria

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;
• 11.Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;
• 12.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;
• 13.Tumor invasion of surrounding important structures (such as mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula;
• 14.Uncontrolled or clinically significant infections
• 15.History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
• 16.Had a history of organ transplantation, allogeneic bone marrow transplantation or hematopoietic stem cell transplantation;
• 17.Other uncontrolled active disease or acute or chronic diseases or abnormal laboratory test that may: increase risk of study participation or study drug administration, interfere with the interpretation of study results, and, disqualify the participant for study participation in the Investigator's judgment;
• 18.History of other primary malignant tumors;
• 19.Women who are considered pregnant or are lactating;
• 20.Under neurological, psychiatric disorder or social condition that affects compliance with study requirements, significantly increases the risk of adverse events, or affects participants' ability to provide written informed consent;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 3 centers

• Fujian cancer hospital — Fuzhou
• Hunan Cancer Hospital — Changsha
• Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT06974812 · CIBI3014A101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗