Solid TumorsPhase 1NCT06963281
Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
A Phase 1 study testing IBI3020 in people with Solid Tumors, run by Fortvita Biologics (USA)Inc. at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- IBI3020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 29 Apr 2025to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 contraindications;
- 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;
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- 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.
Who cannot join
- 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;
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- 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 interventional clinical research.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
NEXT Houston
Houston, Texas, 77054
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
NEXT Dallas
Irving, Texas, 75039
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Montefiore Cancer Center
New York, New York, 10461
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
China3 sites, 3 recruiting
- Recruiting
The sixth affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, 85054
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 85054
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 85054
Fortvita Biologics CT.gov Call Center, 650-370-0985, ct.govNotifications@fortvitabio.com
About this study
Official title: A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
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.
- Conditions
- Solid Tumors
- Being tested
- IBI3020
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3020Drug
Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection
| Study group | Role | What they receive |
|---|---|---|
| IBI3020 | Experimental | Not described Receives: Drug: IBI3020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of subjects with adverse events
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to 3 years
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in electrocardiogram
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Measured: Up to 3 years
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Measured: Up to 21 days
objective response rate (ORR)
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
Number of subjects with clinically significant changes in laboratory parameters
Clinically significant abnormal laboratory parameters findings reported by the investigator.
Measured: Up to 3 years
Secondary outcomes (13)
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3020
Measured: Up to 3 years
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3020
Measured: Up to 3 years
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3020
Measured: Up to 3 years
clearance (CL)
clearance (CL) of single and multiple doses of IBI3020
Measured: Up to 3 years
apparent volume of distribution (V)
apparent volume of distribution (V) of single and multiple doses of IBI3020
Measured: Up to 3 years
half-life (t1/2)
half-life (t1/2) of IBI3020 to the last administration of IBI3020
Measured: Up to 3 years
anti-drug antibody (ADA)
Incidence and characterization of anti-drug antibody (ADA).
Measured: Up to 3 years
objective response rate (ORR)
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
duration of response (DoR)
duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
time to response (TTR)
time to response (TTR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
progression free survival (PFS)
as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
disease control rate (DCR)
disease control rate (DCR)as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
overall survival (OS)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start29 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fortvita Biologics (USA)Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963281
- Sponsor's protocol ID
- "CIBI3020A101"
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06963281
- Acronym / sponsor ID
- "CIBI3020A101"
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Fortvita Biologics (USA)Inc.Industry (pharma, biotech, devices)
- Collaborators
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI3020 | Experimental | Drug: IBI3020 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 contraindications;
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3020Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection | Drug | IBI3020 |
Primary outcome
Numbers of subjects with adverse events
Time frame: Up to 3 years
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in physical examination results
Time frame: Up to 3 years
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram
Time frame: Up to 3 years
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Time frame: Up to 3 years
Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Dose limiting toxicities (DLTs)
Time frame: Up to 21 days
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
objective response rate (ORR)
Time frame: Up to 3 years
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Number of subjects with clinically significant changes in laboratory parameters
Time frame: Up to 3 years
Clinically significant abnormal laboratory parameters findings reported by the investigator.
13 secondary outcomes
area under the curve (AUC)
Time frame: Up to 3 years
maximum concentration (Cmax)
Time frame: Up to 3 years
time to maximum concentration (Tmax)
Time frame: Up to 3 years
clearance (CL)
Time frame: Up to 3 years
apparent volume of distribution (V)
Time frame: Up to 3 years
half-life (t1/2)
Time frame: Up to 3 years
anti-drug antibody (ADA)
Time frame: Up to 3 years
objective response rate (ORR)
Time frame: Up to 3 years
duration of response (DoR)
Time frame: Up to 3 years
time to response (TTR)
Time frame: Up to 3 years
progression free survival (PFS)
Time frame: Up to 3 years
disease control rate (DCR)
Time frame: Up to 3 years
overall survival (OS)
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3020 in people with Solid Tumors, run by Fortvita Biologics (USA)Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fortvita Biologics CT.gov Call Center (650-370-0985, ct.govNotifications@fortvitabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of subjects with adverse events (time frame: Up to 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.