NCT07617493RecruitingPhase 1
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
Beijing InnoCare Pharma Tech Co., Ltd.1 site in 1 country539 target enrollmentStarted: July 3, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 539
- Locations
- 1
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •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;
- •Other circumstances that the researcher deems unsuitable for participation in this study.
Arms & Interventions
ICP-B208
Experimental
Intervention: ICP-B208 (Drug)
Investigators
Study Sites (1)
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