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Not yet recruitingNCT07136558Updated Aug 22, 2025

Evaluation of ICP-B794 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of ICP-B794 in Advanced Solid Tumors, sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Beijing InnoCare Pharma Tech Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
410
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd. is the lead sponsor of 57 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years and ≤75 years.
  2. Histologically confirmed other locally advanced or metastatic solid tumors.
  3. Life expectancy ≥3 months.
  4. Adequate organs function within 7 days prior to the first dose of ICP-B794
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。
  6. At least one measurable lesion per RECIST V1.1 criteria.
  7. Able to provide archived tumor tissue sample (within 2 years) or fresh tumor tissue sample.
  8. Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening.
  9. WOCBP and male participants must agree to use contraceptive method.
  10. Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose of investigational drug.
  11. Participants must be able to communicate effectively with investigators and comply with all study requirements.
  12. Participants voluntarily joined the study and signed the informed concent form (ICF).

Exclusion criteria

Exclusion Criteria:

  1. Other active primary malignancies within 3 years prior to the first dose of investigational product.
  2. Prior or current treatment with the similar drug or related treatment specified in the protocol.
  3. Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.
  4. Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).
  5. Major arterial or venous thrombotic events within 3 months prior to first dose.
  6. Active bleeding within 2 months prior to screening or history of clinically significant bleeding tendency.
  7. Major surgery within 28 days prior to first dose or minor surgery within 2 weeks prior to first dose.
  8. Requirement for systemic corticosteroid therapy within 14 days prior to first dose.
  9. 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.
  10. Administration of any live vaccine within 4 weeks prior to first dose or history of hypersensitivity reactions of any grade.
  11. Female participants who are pregnant, lactating, or planning pregnancy during the study.
  12. Any psychiatric or cognitive disorder that may impair understanding or execution of the informed consent document and/or protocol compliance
  13. Other conditions determined by the investigator that render patients unsuitable for participation in this study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    ICP-B794

    Drug: ICP-B794

Interventions

  • DrugICP-B794

    Intravenous administration once every 3 weeks

06

What researchers measure

Primary outcomes

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

    Time frame: Up to 2 years

  2. Dose-limiting toxicities (DLT)

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

  4. Objective response rate (ORR)

    Time frame: Up to 2 years

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Up to 2 years

  2. Time to Maximum Plasma Concentration (Tmax)

    Time frame: Up to 2 years

  3. Half-life (T1/2)

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

  6. Apparent Clearance (CL/F)

    Time frame: Up to 2 years

  7. Terminal Apparent Volume of Distribution (Vz/F)

    Time frame: Up to 2 years

  8. Objective Response Rate (ORR)

    Time frame: Up to 2 years

  9. Disease control rate (DCR)

    Time frame: Up to 2 years

  10. Duration of response (DOR)

    Time frame: Up to 2 years

  11. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

  12. Radiographic progression-free survival (rPFS)

    Time frame: Up to 2 years

  13. Overall survival (OS)

    Time frame: Up to 2 years

  14. Number of participants with anti-drug antibodies (ADA) to ICP-B794

    Time frame: Up to 2 years

Other outcomes

  1. B7-H3 protein expression

    Time frame: Up to 2 years

07

Study locations

1 site
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07136558
Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Responsible party
Sponsor
First posted
Aug 22, 2025
Start date
Aug 2025 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Aug 22, 2025

Study contacts

Yilong Wu
Contact
syylwu@live.cn
13809775415
Yilong Wu
principal investigator · Guangdong Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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