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A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced breast cancer.

Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject must sign the written informed consent form (ICF) voluntarily;

At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;

ECOG performance status score of 0 or 1;

Has a life expectancy of ≥ 3 months;

Disqualifiers

Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;

Presence of active central nervous system (CNS) metastases.

Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;

Untreated subjects with active hepatitis B or active hepatitis C;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK138D1

    Drug

    Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.

  • Ivonescimab

    Drug

    Enrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort.

  • treatment of physician's choice

    Drug

    Enrolled subjects will receive treatment of physician's choice according to one of the protocol-specified regimens selected by the investigator, based on the investigator's decision.

Treatment groups

286 Participants
are divided into 3 treatment groups
Group A: AK138D1Experimental treatment 1 intervention
Group B: AK138D1+ivonescimabExperimental treatment 2 interventions
Group C: Treatment of Physician's ChoiceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Incidence and severity of participants with adverse events

Time frame
Up to approximately 2 years
2

Overall Response Rate (ORR) assessed by investigator per RECIST v1.1

ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

Time frame
Up to approximately 2 years

Secondary outcomes

1

Peak Plasma Concentration (Cmax)

Derum drug concentrations in subjects at different time points after administration.

Time frame
Up to approximately 2 years
2

Area under the plasma concentration versus time curve (AUC)

The definite integral of the concentration of AK138D1 in blood plasma as a function of time.

Time frame
Up to approximately 2 years
3

Anti-drug antibodies (ADA)

Number of subjects with detectable anti-drug antibodies (ADA).

Time frame
Up to approximately 2 years
4

Disease Control Rate (DCR) assessed by investigator per RECIST v1.1

Disease control rate (DCR) assessed according to RECIST v1.1.

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

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

Akeso

Lead sponsor

Source ClinicalTrials.gov

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