Evaluation of ICP-B208 in Patients With Advanced Solid Tumors

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: ICP-B208

• Study Type: Interventional
• Enrollment (Estimated): 539
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Aixia Lu; Phone Number: 010-66609745; Email: CO_HGRAC@innocarepharma.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Beijing Cancer Hospital
      • Contact: Lin Shen, M.D.; Phone Number: 010-88196561; Email: doctorshenlin@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years old to 75 years old;
2. 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;
3. The ECOG physical fitness score is 0 to 1 point.
4. There is at least one measurable lesion;
5. The organ function level must meet the prescribed standards;
6. 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.
7. Voluntarily enroll in the group and sign the informed consent form, and follow the trial treatment protocol and visit plan.

Exclusion Criteria:

1. Other active malignant tumors occurred within 3 years before the first administration of the study drug;
2. 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;
3. Trial participants with unstable primary CNS tumors or CNS metastases;
4. Uncontrollable or significant major cardiovascular diseases;
5. Severe or uncontrollable systemic diseases; Or any unstable systemic disease;
6. Active infection as defined in the plan;
7. Have a history of severe allergic reactions to active pharmaceutical ingredients, non-active components in drugs or antibody drugs;
8. Those who are known to have a history of alcohol abuse or drug abuse;
9. Other circumstances that the researcher deems unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-B208	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The types, severity, correlation with the investigational drug and incidence of adverse events and serious adverse events	2 years
The types, severity and incidence of dose-limiting toxicity (DLT)	1 year
The Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD)	1 year
Objective response rate (ORR) by researchers	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax)	1 year
Time to Maximum Plasma Concentration (Tmax)	1 year
Half-life (T1/2)	1 year
Area under the concentration-time curve from zero time to infinity (AUC0-∞)	1 year
Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)	1 year
Apparent Clearance(CL/F)	1 year
Terminal Apparent Volume of Distribution (Vz/F)	1 year
The ORR evaluated by the researchers	2 years
The Disease Control Rate (DCR) evaluated by the researchers	2 years
The Duration of Response (DOR) evaluated by the researchers	2 years
The Progression-Free Survival (PFS) evaluated by the researchers	2 years
The Radiographic Progression-Free Survival (rPFS) evaluated by the researchers	2 years
The Overall Survival (OS) evaluated by the researchers	2 years
Number of participants with anti-drug antibodies (ADA) to ICP-B208	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ICP-CL-01801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No