AK138D1 alone or with Ivonescimab in advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase Ib/II trial evaluating AK138D1 as a standalone treatment or in combination with Ivonescimab for patients with advanced NSCLC. The phase Ib portion focuses on safety, tolerability, and preliminary antitumor activity, while the phase II portion assesses safety and efficacy of both AK138D1 strategies. Participants may receive AK138D1 alone, AK138D1 with Ivonescimab, or other allowable regimens including Carboplatin as part of the study framework. Safety assessments, tumor measurements, and clinical outcomes will be collected throughout treatment. Eligible patients are adults up to 75 with measurable disease and good performance status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xufang Yu
• Email: clinicaltrials@akesobio.com
• Phone: +86 (0760) 89873999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.