Health TrialsbyHealthPanel

Evaluation of ICP-B208 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
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
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