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

Akeso

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Ivonescimab; Drug: AK138D1; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07623356

AK138D1-201

Details and patient eligibility

About

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.

Full description

This is a multicenter, open-label phase Ib/II study of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. The phase Ib portion is designed to evaluate the safety, tolerability, and preliminary antitumor activity of AK138D1 in combination with ivonescimab. The phase II portion is designed to evaluate the safety and efficacy of AK138D1 as monotherapy or in combination with ivonescimab.

Enrollment: 265 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject must sign the written informed consent form (ICF) voluntarily;
2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. Has a life expectancy of ≥ 3 months;
5. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
6. Has Stage IIIB/IIIC or IV non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer [AJCC]).
7. Adequate organ function.

Exclusion criteria

1. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
2. Presence of active central nervous system (CNS) metastases.
3. 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;
4. Untreated subjects with active hepatitis B or active hepatitis C;
5. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
6. Known active syphilis infection;
7. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
8. Other reasons for ineligibility as evaluated by investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

265 participants in 3 patient groups

AK138D1

Experimental group

Description:

AK138D1 will be administered at pre-specified dose levels.

Treatment:

Drug: AK138D1

AK138D1+ Ivonescimab

Experimental group

Description:

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

Treatment:

Drug: AK138D1

Drug: Ivonescimab

AK138D1 + Ivonescimab + Carboplatin

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: AK138D1

Drug: Ivonescimab