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Not yet recruiting NCT07136558

Evaluation of ICP-B794 in Patients With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICP-B794.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Drug ICP-B794
    Intravenous administration once every 3 weeks

Primary outcome measures

  • Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0 [Time frame: Up to 2 years]
  • Dose-limiting toxicities (DLT) [Time frame: Up to 2 years]
  • The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD) [Time frame: Up to 2 years]
  • Objective response rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (12)
  • Maximum Plasma Concentration (Cmax) [Time frame: Up to 2 years]
  • Time to Maximum Plasma Concentration (Tmax) [Time frame: Up to 2 years]
  • Half-life (T1/2) [Time frame: Up to 2 years]
  • Area under the concentration-time curve from zero time to infinity (AUC0-∞) [Time frame: Up to 2 years]
  • 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]
  • Apparent Clearance (CL/F) [Time frame: Up to 2 years]
  • Terminal Apparent Volume of Distribution (Vz/F) [Time frame: Up to 2 years]
  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
  • Disease control rate (DCR) [Time frame: Up to 2 years]
  • Duration of response (DOR) [Time frame: Up to 2 years]
  • Progression-Free Survival (PFS) [Time frame: Up to 2 years]
  • Radiographic progression-free survival (rPFS) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT07136558 · ICP-CL-01501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗