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Evaluation of ICP-B208 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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).

Treatment groups

539 Participants
are divided into 1 treatment group
Group A: ICP-B208Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: