Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

About this trial

This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able to understand and sign written informed consent to participate in this study, including all assessments and procedures specified in this protocol;

Male or female participants aged 18 years or older;

Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors;

Have at least one evaluable lesion (dose escalation) or measurable lesion (dose expansion) as per RECIST v1.1 within 28 days prior to the first dose of IBI3028;

Disqualifiers

Participation in any other interventional clinical study other than an observational (non-interventional) study or during the follow-up period of an interventional study;

Have received live vaccines within 4 weeks or tumor vaccines within 3 months prior to the first administration of the study drug, or plan to receive any live vaccines during the study;

Use of strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitors within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug;

Adverse reactions caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 or baseline level according to NCI CTCAE v5.0 before the first dose of the study drug (except for alopecia, fatigue, pigmentation, and other conditions with no safety implications per the Investigator's clinical judgement);

Trial design

Design model

Sequential

Treatments tested in this trial

  • Drug: IBI3028

    Drug

    Recombinant anti-EGFR(Epidermal growth factor receptor) and c-Met antibodies-dual-payload conjugate for injection

Treatment groups

493 Participants
are divided into 1 treatment group
Group A: Drug: IBI3028Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Numbers of subjects with adverse events

Defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

Time frame
Up to 3 years
2

Numbers of subjects with serious adverse events

Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

Time frame
Up to 3 years
3

Number of subjects with clinically significant changes in laboratory parameters

Clinically significant abnormal laboratory parameters findings reported by the investigator.

Time frame
Up to 3 years
4

Number of subjects with clinically significant changes in electrocardiogram

Clinically significant abnormal electrocardiogram findings reported by the investigator.

Time frame
Up to 3 years

Secondary outcomes

1

Area under the curve (AUC)

Area under the curve (AUC) of single and multiple doses of IBI3028

Time frame
Up to 3 years
2

Maximum concentration (Cmax)

Maximum concentration (Cmax) of single and multiple doses of IBI3028

Time frame
Up to 3 years
3

Time to maximum concentration (Tmax)

Time to maximum concentration (Tmax) of single and multiple doses of IBI3028

Time frame
Up to 3 years
4

Clearance (CL)

Clearance (CL) of single and multiple doses of IBI3028

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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