NCT07067567 A Study of AK146D1 for Injection in Advanced Solid Tumors
| NCT ID | NCT07067567 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Akeso |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2026-11-05 |
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 2025-08-07 with a primary completion date of 2026-11-05.
⚠ 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 an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Be able to understand and voluntarily sign the written informed consent form. 2. Aged of ≥ 18 years and ≤75 years. 3. ECOG PS 0 or 1. 4. The expected lifespan is ≥3 months. 5. Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available. 6. At least one measurable lesion according to RECIST v1.1. 7. Have sufficient organ function. 8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception Exclusion Criteria: 1. Having other active malignancies within 3 years. 2. Currently participating in another interventional clinical study. 3. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included. 4. Having received any treatment targeting Trop2 or Nectin4. 5. Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration. 6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower. 7. Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks. 8. Subjects with active autoimmune diseases requiring systemic treatment within 2 years. 9. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose. 10. Known to be positive for HIV and other infections. 11. Previous history of severe hypersensitivity reactions. 12. Live attenuated vaccines were received within 4 weeks. 13. Subjects with a history of mental illness and incapacitated or limited capacity. 14. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07067567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumors. 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 NCT07067567 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 NCT07067567 currently recruiting?
Yes, NCT07067567 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT07067567 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07067567 clinical trial?
NCT07067567 is sponsored by Akeso. The trial plans to enroll 200 participants.