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New treatment option for Solid Tumors
Official title Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
ClinicalTrials.gov ID: NCT06963281
What this study is testing
What is IBI3020?
IBI3020 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for 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
- The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
- 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 to 75
You may be able to join if
- Participants must satisfy all of the following criteria to be enrolled into the study:
- Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and...
- Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies...
- At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
You likely can't join if
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Previous treatment with CEACAM5-targeted therapy;
- Prior anti-cancer therapy within the wash-out period;
- Received live vaccines within 4 weeks or cancer vaccine within 3 months;
- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
- 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;
See the full eligibility criteria
- Participants must satisfy all of the following criteria to be enrolled into the study:
- Participants have 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. For Part 1, age ≥ 18 years and ≤ 75 years;
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or...
- At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Minimum life expectancy of 12 weeks;
- Adequate bone marrow and organ function confirmed at screening period;
- Participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study.
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Previous treatment with CEACAM5-targeted therapy;
- Prior anti-cancer therapy within the wash-out period;
- Received live vaccines within 4 weeks or cancer vaccine within 3 months;
- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
- 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;
- Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;
- Undergone major surgery within 4 weeks, or who have severe unhealed wounds;
- Known symptomatic central nervous system (CNS) metastases;
- Uncontrolled diseases or conditions;
- History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;
- History of thromboembolic event within 6 months;
- Under neurological, psychiatric or social condition;
- Women who are pregnant, have positive results in pregnancy test or are lactating;
- Not eligible to participate in this study at the discretion of the investigator;
- Participating in any other treatment clinical research.
The study team makes the final eligibility decision.
Where it's taking place
- Pheonix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Guangzhou, Guangdong, China
- Jinan, Shandong, China
- Taiyuan, Shanxi, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pheonix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; New York, New York, United States; Houston, Texas, United States; Irving, Texas, United States and 3 more location(s). 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.