Evaluation of ICP-B208 in Patients With Advanced Solid Tumors

NCT07617493 | Recruiting Phase 1

• 1 other identifier: ICP-CL-01801
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• 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

Study Arms (1)

ICP-B208

EXPERIMENTAL

Drug: ICP-B208

Interventions

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).

ICP-B208

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

Aixia Lu

CONTACT

010-66609745; CO_HGRAC@innocarepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 1, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CN (1)