NCT07281326 A Study of AK138D1 in Advanced Malignant Tumors
| NCT ID | NCT07281326 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Akeso |
| Condition | Solid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2026-10-22 |
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 200 participants in total. It began in 2025-10-22 with a primary completion date of 2026-10-22.
⚠ 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
This is a Phase I clinical trial testing the safety and effectiveness of AK138D1in patients with advanced cancer. The study will enroll up to 200 patients with various types of advanced solid tumors who haven't responded to standard treatments. Patients will receive AK138D1 to determine the safest dose and evaluate if the drug can help treat their cancer.
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. ECOG performance status score of 0 or 1; 4. Has a life expectancy of ≥ 3 months; 5. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement. 6. Adequate organ function. Exclusion Criteria: 1. Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others; 2. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study; 3. Presence of active central nervous system (CNS) metastases. 4. 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; 5. Untreated subjects with active hepatitis B or active hepatitis C; 6. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease; 7. Known active syphilis infection; 8. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies; 9. Other reasons for ineligibility as evaluated by the investigator.
Contact & Investigator
Wenting Li, MD
STUDY DIRECTOR
Akeso
Frequently Asked Questions
Who can join the NCT07281326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid 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 NCT07281326 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 NCT07281326 currently recruiting?
Yes, NCT07281326 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT07281326 trial being conducted?
This trial is being conducted at Harbin, China.
Who is sponsoring the NCT07281326 clinical trial?
NCT07281326 is sponsored by Akeso. The principal investigator is Wenting Li, MD at Akeso. The trial plans to enroll 200 participants.
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