ICP-B208 in people with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined Phase 1/2 interventional study evaluating ICP-B208 in adults with unresectable or metastatic solid tumors. It will assess safety, tolerability, efficacy, and pharmacokinetics of the therapy. Eligible participants have measurable disease, adequate organ function, and a good performance status, and must have exhausted prior systemic treatment. The study is conducted at sites in Beijing and Jinan, under a lead sponsor in collaboration with Beijing InnoCare Pharma Tech. Enrollment will follow a protocol with defined visit plans and monitoring. Exclusion criteria include recent other active malignancies or recent anti-tumor treatment outside protocol allowances.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years old to 75 years old;
2. 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;
3. The ECOG physical fitness score is 0 to 1 point.
4. There is at least one measurable lesion;
5. The organ function level must meet the prescribed standards;
6. 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.
7. Voluntarily enroll in the group and sign the informed consent form, and follow the trial treatment protocol and visit plan.

Exclusion Criteria:

1. Other active malignant tumors occurred within 3 years before the first administration of the study drug;
2. 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;
3. Trial participants with unstable primary CNS tumors or CNS metastases;
4. Uncontrollable or significant major cardiovascular diseases;
5. Severe or uncontrollable systemic diseases; Or any unstable systemic disease;
6. Active infection as defined in the plan;
7. Have a history of severe allergic reactions to active pharmaceutical ingredients, non-active components in drugs or antibody drugs;
8. Those who are known to have a history of alcohol abuse or drug abuse;
9. There is pleural effusion, ascites, pericardial effusion that requires clinical intervention;
10. Severe arteriovenous thrombotic events occurred within 3 months before the first administration, or anticoagulant drugs are currently being taken;
11. Other circumstances that the researcher deems unsuitable for participation in this study.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing GoBroad Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cancer Hospital of Shandong First Medical University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Jingnan Yang
• Email: CO-Clinicaltrial@innocarepharma.com
• Phone: 010-66609990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.