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Recruiting NCT07617493

Evaluation of ICP-B208 in Patients With Advanced Solid Tumors

Phase I / Phase II Interventional Advanced Solid Tumor

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-B208.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors

Interventions

  • Drug ICP-B208
    ICP-B208 will be administered by intravenous infusion every 3 weeks (Q3W) until disease progression (PD) or the occurrence of unacceptable toxicity or withdrawal from the study for other reasons (whichever occurs first).

Primary outcome measures

  • The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events [Time frame: 2 years]
  • The types, severity and incidence of dose-limiting toxicity (DLT) [Time frame: 1 year]
  • The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD) [Time frame: 1 year]
  • Objective response rate (ORR) by researchers [Time frame: 2 years]
Secondary outcome measures (12)
  • Maximum Plasma Concentration (Cmax) [Time frame: 1 year]
  • Time to Maximum Plasma Concentration (Tmax) [Time frame: 1 year]
  • Half-life (T1/2) [Time frame: 1 year]
  • Area under the concentration-time curve from zero time to infinity (AUC0-∞) [Time frame: 1 year]
  • Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t) [Time frame: 1 year]
  • Apparent Clearance(CL/F) [Time frame: 1 year]
  • Terminal Apparent Volume of Distribution (Vz/F) [Time frame: 1 year]
  • The ORR evaluated by the researchers [Time frame: 2 years]
  • The Disease Control Rate (DCR) evaluated by the researchers [Time frame: 2 years]
  • The Duration of Response (DOR) evaluated by the researchers [Time frame: 2 years]
  • The Progression-Free Survival (PFS) evaluated by the researchers [Time frame: 2 years]
  • The Radiographic Progression-Free Survival (rPFS) evaluated by the researchers [Time frame: 2 years]

Eligibility criteria

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.

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
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07617493 · ICP-CL-01801

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗