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

NCT07623356 | Not Yet Recruiting Phase 1

• 1 other identifier: AK138D1-201
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  Incidence and severity of subjects with adverse events

  Up to approximately 2 years

• 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.

  Up to approximately 2 years

Secondary Outcomes (7)

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

• Progression Free Survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

Study Arms (3)

AK138D1

EXPERIMENTAL

AK138D1 will be administered at pre-specified dose levels.

Drug: AK138D1

AK138D1+ Ivonescimab

EXPERIMENTAL

AK138D1 and ivonescimab will be administered at pre-specified dose levels.

Drug: AK138D1; Drug: Ivonescimab

AK138D1 + Ivonescimab + Carboplatin

EXPERIMENTAL

AK138D1, ivonescimab and carboplatin will be administered at pre-specified dose levels.

Drug: AK138D1; Drug: Ivonescimab; Drug: Carboplatin

Interventions

AK138D1 DRUG

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

AK138D1; AK138D1 + Ivonescimab + Carboplatin; AK138D1+ Ivonescimab

Ivonescimab DRUG

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

AK138D1 + Ivonescimab + Carboplatin; AK138D1+ Ivonescimab

Carboplatin DRUG

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

AK138D1 + Ivonescimab + Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Has Stage IIIB/IIIC or IV NSCLC (American Joint Committee on Cancer \[AJCC\]).
• Adequate organ function.

You may not qualify if:

• 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;
• Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
• Known active syphilis infection;
• Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
• Other reasons for ineligibility as evaluated by investigator.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Xufang Yu

CONTACT

+86 (0760) 89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): June 18, 2028
• Study Completion (Estimated): July 3, 2030
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (1)