NCT07623356 A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer
| NCT ID | NCT07623356 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Akeso |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 265 participants |
| Start Date | 2026-07-07 |
| Primary Completion | 2028-06-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 265 participants in total. It began in 2026-07-07 with a primary completion date of 2028-06-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07623356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07623356 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07623356 currently recruiting?
Yes, NCT07623356 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT07623356 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07623356 clinical trial?
NCT07623356 is sponsored by Akeso. The trial plans to enroll 265 participants.
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