Two-Payload antibody aims at Hard-to-Treat solid tumors
NCT ID NCT06963281
First seen Sep 25, 2026 · Last updated Sep 25, 2026
Summary
Researchers are testing an experimental drug called IBI3020 in adults with solid tumors that have spread or cannot be removed by surgery. IBI3020 is an antibody-drug conjugate that targets the CEACAM5 protein on tumor cells and delivers two different payloads. The main goals are to find out whether the drug is safe, what side effects it causes, and the best dose to test in future studies. The trial also checks whether tumors shrink in response to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antibody-drug conjugate called IBI3020 that carries two payloads and targets the CEACAM5 protein on tumor cells
- What this could lead to
- If it works, this could point toward a new treatment option for several types of advanced solid tumors that share the CEACAM5 marker.
- What could go wrong
- This is a first-in-human phase 1 trial, so the main goal is safety, not cure. Many experimental cancer drugs fail at this stage because of side effects or because they do not shrink tumors enough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 285 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must satisfy all of the following criteria to be enrolled into the study: 1. 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; 2. Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years; 3. 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 contraindications; 4. At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1; 6. Minimum life expectancy of 12 weeks; 7. Adequate bone marrow and organ function confirmed at screening period; 8. 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. Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: 1. Previous treatment with CEACAM5-targeted therapy; 2. Prior anti-cancer therapy within the wash-out period; 3. Received live vaccines within 4 weeks or cancer vaccine within 3 months; 4. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives; 5. 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; 6. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients; 7. Undergone major surgery within 4 weeks, or who have severe unhealed wounds; 8. Known symptomatic central nervous system (CNS) metastases; 9. Uncontrolled diseases or conditions; 10. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases; 11. History of thromboembolic event within 6 months; 12. Under neurological, psychiatric or social condition; 13. Women who are pregnant, have positive results in pregnancy test or are lactating; 14. Not eligible to participate in this study at the discretion of the investigator; 15. Participating in any other interventional clinical research.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic - Arizona
RECRUITINGPhoenix, Arizona, 85054, United States
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Mayo Clinic - Florida
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic - Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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Montefiore Cancer Center
RECRUITINGNew York, New York, 10461, United States
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NEXT Dallas
RECRUITINGIrving, Texas, 75039, United States
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NEXT Houston
RECRUITINGHouston, Texas, 77054, United States
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Shandong Cancer Hospital
RECRUITINGJinan, Shandong, 85054, China
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Shanxi Cancer Hospital
RECRUITINGTaiyuan, Shanxi, 85054, China
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The sixth affiliated hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 85054, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new antibody pair unlock the immune system against Hard-to-Treat tumors?
- Can a single zap to the gut make immunotherapy work better against liver tumors?
- First-in-Human trial puts BA1203 to the test against advanced solid tumors
- Can an EGFR-Targeting antibody pair with chemotherapy? trial maps the Drug's path through the body
- Can a cheap mineral shield kidneys from chemotherapy damage?