Advanced Solid TumorPhase 1/2NCT07617493
Evaluation of ICP-B208 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing ICP-B208 in people with Advanced Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 3 sites in China.
Trial summary
To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ICP-B208
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 551 participants
- Where
- 3 sitesChina
- Study dates
- 3 Jul 2026to Jun 2031
- Phase
- Phase 1/2
- 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
- 18 years old to 75 years old;
- Unresectable locally advanced or metastatic gastrointestinal tumors or other advanced solid tumors that have failed previous systemic treatment and have been confirmed by histopathology or cytology;
- The ECOG physical fitness score is 0 to 1 point.
- There is at least one measurable lesion;
- The organ function level must meet the prescribed standards;
- Effective contraceptive measures should be taken from the date of signing the informed consent form until at least 6 months after the use of the last dose of the study drug.
- Voluntarily enroll in the group and sign the informed consent form, and follow the trial treatment protocol and visit plan.
Who cannot join
- Other active malignant tumors occurred within 3 years before the first administration of the study drug;
- Received the anti-tumor treatment defined by the protocol within the time range before the first administration of the study drug specified in the protocol;
- Trial participants with unstable primary CNS tumors or CNS metastases;
- Uncontrollable or significant major cardiovascular diseases;
- Severe or uncontrollable systemic diseases; Or any unstable systemic disease;
- Active infection as defined in the plan;
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- Have a history of severe allergic reactions to active pharmaceutical ingredients, non-active components in drugs or antibody drugs;
- Those who are known to have a history of alcohol abuse or drug abuse;
- There is pleural effusion, ascites, pericardial effusion that requires clinical intervention;
- Severe arteriovenous thrombotic events occurred within 3 months before the first administration, or anticoagulant drugs are currently being taken;
- Other circumstances that the researcher deems unsuitable for participation in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Lin Shen, M.D., 010-88196561, doctorshenlin@sina.cn
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100000
Ming Lu, M.D., 15801292978, minglupku@126.com
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250000
Yuping Sun, M.D., 0531-67627156, 13370582181@163.com
About this study
Official title: An Open, Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of ICP-B208 in Participants of Advanced Solid Tumor Trials
To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors
- Conditions
- Advanced Solid Tumor
- Being tested
- ICP-B208
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-B208Drug
ICP-B208 will be administered by intravenous infusion every 3 weeks (Q3W) until disease progression (PD) or the occurrence of unacceptable toxicity or withdrawal from the study for other reasons (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| ICP-B208 | Experimental | Not described Receives: Drug: ICP-B208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events
Measured: 2 years
The types, severity and incidence of dose-limiting toxicity (DLT)
Measured: 1 year
The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD)
Measured: 1 year
Objective response rate (ORR) by researchers
Measured: 2 years
Secondary outcomes (13)
Maximum Plasma Concentration (Cmax)
Measured: 1 year
Time to Maximum Plasma Concentration (Tmax)
Measured: 1 year
Half-life (T1/2)
Measured: 1 year
Area under the concentration-time curve from zero time to infinity (AUC0-∞)
Measured: 1 year
Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)
Measured: 1 year
Apparent Clearance(CL/F)
Measured: 1 year
Terminal Apparent Volume of Distribution (Vz/F)
Measured: 1 year
The ORR evaluated by the researchers
Measured: 2 years
The Disease Control Rate (DCR) evaluated by the researchers
Measured: 2 years
The Duration of Response (DOR) evaluated by the researchers
Measured: 2 years
The Progression-Free Survival (PFS) evaluated by the researchers
Measured: 2 years
The Overall Survival (OS) evaluated by the researchers
Measured: 2 years
Number of participants with anti-drug antibodies (ADA) to ICP-B208
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start3 Jul 2026
- Primary completionDec 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 551 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617493
- Sponsor's protocol ID
- ICP-CL-01801
- Status last verified
- Nov 2026
- First submitted
- 14 May 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of ICP-B208 in Participants of Advanced Solid Tumor Trials
- ClinicalTrials.gov ID
- NCT07617493
- Acronym / sponsor ID
- ICP-CL-01801
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 551 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 1 Jun 2026 (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.
To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-B208 | Experimental | Drug: ICP-B208 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old to 75 years old;
- Unresectable locally advanced or metastatic gastrointestinal tumors or other advanced solid tumors that have failed previous systemic treatment and have been confirmed by histopathology or cytology;
- The ECOG physical fitness score is 0 to 1 point.
- There is at least one measurable lesion;
- The organ function level must meet the prescribed standards;
Key exclusion criteria (11 listed)
- Other active malignant tumors occurred within 3 years before the first administration of the study drug;
- Received the anti-tumor treatment defined by the protocol within the time range before the first administration of the study drug specified in the protocol;
- Trial participants with unstable primary CNS tumors or CNS metastases;
- Uncontrollable or significant major cardiovascular diseases;
- Severe or uncontrollable systemic diseases; Or any unstable systemic disease;
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 |
|---|---|---|
| ICP-B208ICP-B208 will be administered by intravenous infusion every 3 weeks (Q3W) until disease progression (PD) or the occurrence of unacceptable toxicity or withdrawal from the study for other reasons (whichever occurs first). | Drug | ICP-B208 |
Primary outcome
The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events
Time frame: 2 years
The types, severity and incidence of dose-limiting toxicity (DLT)
Time frame: 1 year
The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD)
Time frame: 1 year
Objective response rate (ORR) by researchers
Time frame: 2 years
13 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 1 year
Time to Maximum Plasma Concentration (Tmax)
Time frame: 1 year
Half-life (T1/2)
Time frame: 1 year
Area under the concentration-time curve from zero time to infinity (AUC0-∞)
Time frame: 1 year
Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)
Time frame: 1 year
Apparent Clearance(CL/F)
Time frame: 1 year
Terminal Apparent Volume of Distribution (Vz/F)
Time frame: 1 year
The ORR evaluated by the researchers
Time frame: 2 years
The Disease Control Rate (DCR) evaluated by the researchers
Time frame: 2 years
The Duration of Response (DOR) evaluated by the researchers
Time frame: 2 years
The Progression-Free Survival (PFS) evaluated by the researchers
Time frame: 2 years
The Overall Survival (OS) evaluated by the researchers
Time frame: 2 years
Number of participants with anti-drug antibodies (ADA) to ICP-B208
Time frame: 1 year
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 5 Nov 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ICP-B208 in people with Advanced Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 3 sites in China.
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 7 inclusion and 11 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jingnan Yang (010-66609990, CO-Clinicaltrial@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events (time frame: 2 years). The study lists 4 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 5 Nov 2026.