Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07617493

Evaluation of ICP-B208 in Patients With Advanced Solid Tumors

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Lin Shen, M.D.

CONTACT

[email protected]

010-88196561

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICP-B208

Drug

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 outcomes

  1. The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events

    Time frame: 2 years

  2. The types, severity and incidence of dose-limiting toxicity (DLT)

    Time frame: 1 year

  3. The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD)

    Time frame: 1 year

  4. Objective response rate (ORR) by researchers

    Time frame: 2 years

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 1 year

  2. Time to Maximum Plasma Concentration (Tmax)

    Time frame: 1 year

  3. Half-life (T1/2)

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

  6. Apparent Clearance(CL/F)

    Time frame: 1 year

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

    Time frame: 1 year

  8. The ORR evaluated by the researchers

    Time frame: 2 years

  9. The Disease Control Rate (DCR) evaluated by the researchers

    Time frame: 2 years

  10. The Duration of Response (DOR) evaluated by the researchers

    Time frame: 2 years

  11. The Progression-Free Survival (PFS) evaluated by the researchers

    Time frame: 2 years

  12. The Radiographic Progression-Free Survival (rPFS) evaluated by the researchers

    Time frame: 2 years

  13. The Overall Survival (OS) evaluated by the researchers

    Time frame: 2 years

  14. Number of participants with anti-drug antibodies (ADA) to ICP-B208

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Aixia Lu

CONTACT

[email protected]

010-66609745

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 1, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.