BridgeMD
New treatment option for Unresectable Locally Advanced or Metastatic Solid Tumors
Official title IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06974812
What this study is testing
What is IBI3014?
IBI3014 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unresectable locally advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1.Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and...
- 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...
You likely can't join if
- 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...
- 3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is...
- 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...
- 6.History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g. Interstitial lung disease...
See the full eligibility 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...
- 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;
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Changsha, Hunan, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.