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A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
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 non-small cell lung 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;

Has an Eastern Cooperative Oncology Group (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.

  • Carboplatin

    Drug

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

Treatment groups

265 Participants
are divided into 3 treatment groups
Group A: AK138D1Experimental treatment 1 intervention
Group B: AK138D1+ IvonescimabExperimental treatment 2 interventions
Group C: AK138D1 + Ivonescimab + CarboplatinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Incidence and severity of subjects with adverse events

Time frame
Up to approximately 2 years
2

Objective Response Rate (ORR)

Objective Response Rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR) , assessed by investigator according to RECIST v1.1.

Time frame
Up to approximately 2 years

Secondary outcomes

1

Disease Control Rate (DCR)

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

Time frame
Up to approximately 2 years
2

Duration of response (DoR)

Duration of response (DoR) assessed by investigator according to RECIST v1.1.

Time frame
Up to approximately 2 years
3

Time to response (TTR)

Time to response (TTR) is defined as the time to response assessed by investigator according to RECIST v1.1.

Time frame
Up to approximately 2 years
4

Progression Free Survival (PFS)

Progression Free Survival (PFS) is defined as the time from randomization to the first documented disease progression (per RECIST v1.1) assessed by investigator or death due to any cause, whichever occurs first.

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
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