Evaluation of ICP-B794 in Patients With Advanced Solid Tumors

NCT07136558 | Not Yet Recruiting Phase 1

• 1 other identifier: ICP-CL-01501
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0

  Up to 2 years

• Dose-limiting toxicities (DLT)

  Incidence, character, and severity of dose-limiting toxicities.

  Up to 2 years

• The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD)

  Up to 2 years

• Objective response rate (ORR)

  Up to 2 years

Secondary Outcomes (14)

• Maximum Plasma Concentration (Cmax)

  Up to 2 years

• Time to Maximum Plasma Concentration (Tmax)

  Up to 2 years

• Half-life (T1/2)

  Up to 2 years

• Area under the concentration-time curve from zero time to infinity (AUC0-∞)

  Up to 2 years

• Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)

  Up to 2 years

Other Outcomes (1)

• B7-H3 protein expression

  Up to 2 years

Study Arms (1)

ICP-B794

EXPERIMENTAL

Drug: ICP-B794

Interventions

ICP-B794 DRUG

Intravenous administration once every 3 weeks

ICP-B794

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Study Officials

• Yilong Wu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yilong Wu

CONTACT

13809775415; syylwu@live.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (1)