Status:
NOT_YET_RECRUITING
Evaluation of ICP-B794 in Patients With Advanced Solid Tumors
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors
Eligibility Criteria
Inclusion
- Age ≥18 years and ≤75 years.
- Histologically confirmed other locally advanced or metastatic solid tumors.
- Life expectancy ≥3 months.
- Adequate organs function within 7 days prior to the first dose of ICP-B794
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。
- At least one measurable lesion per RECIST V1.1 criteria.
- Able to provide archived tumor tissue sample (within 2 years) or fresh tumor tissue sample.
- Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening.
- WOCBP and male participants must agree to use contraceptive method.
- Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose of investigational drug.
- Participants must be able to communicate effectively with investigators and comply with all study requirements.
- Participants voluntarily joined the study and signed the informed concent form (ICF).
Exclusion
- Other active primary malignancies within 3 years prior to the first dose of investigational product.
- Prior or current treatment with the similar drug or related treatment specified in the protocol.
- Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.
- Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).
- Major arterial or venous thrombotic events within 3 months prior to first dose.
- Active bleeding within 2 months prior to screening or history of clinically significant bleeding tendency.
- Major surgery within 28 days prior to first dose or minor surgery within 2 weeks prior to first dose.
- Requirement for systemic corticosteroid therapy within 14 days prior to first dose.
- History of severe hypersensitivity, or known severe hypersensitivity to the active pharmaceutical ingredient, inactive ingredients in the drug product, or antibody-based drugs, or hypersensitivity to recombinant human or murine proteins, or history of severe infusion reaction.
- Administration of any live vaccine within 4 weeks prior to first dose or history of hypersensitivity reactions of any grade.
- Female participants who are pregnant, lactating, or planning pregnancy during the study.
- Any psychiatric or cognitive disorder that may impair understanding or execution of the informed consent document and/or protocol compliance
- Other conditions determined by the investigator that render patients unsuitable for participation in this study.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT07136558
Start Date
August 1 2025
End Date
December 1 2030
Last Update
August 22 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000