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New treatment option for Locally Advanced Solid Tumor
Official title IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06349408
What this study is testing
What is IBI3001?
IBI3001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced solid tumor.
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 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.
- Phase 1: an early, usually small safety study
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
- Male or female participants ≥ 18 years old;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Has an anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function:
- At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable...
You likely can't join if
- Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that...
- Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must...
- Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
- Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical...
- Known symptomatic central nervous system (CNS) metastases.
- History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
See the full eligibility criteria
- Male or female participants ≥ 18 years old;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Has an anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function:
- 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.
- 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...
- 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;
- 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;
- Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
- Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
- Known symptomatic central nervous system (CNS) metastases.
- History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
- History of endotracheal or gastrointestinal stent implantation;
- Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
- Esophageal or gastric varices requiring immediate intervention;
- Not eligible to participate in this study at the discretion of the investigator;
- Do not have adequate treatment washout period before study drug administration. -
The study team makes the final eligibility decision.
Where it's taking place
- Wollongong, New South Wales, Australia
- Adelaide, South Australia, Australia
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, 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 Wollongong, New South Wales, Australia; Adelaide, South Australia, Australia; Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, 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.