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NCT06929663 | NOT YET RECRUITING | Advanced Solid Tumors

A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors
Sponsor:

Akeso

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.

Condition or disease

Advanced Solid Tumors

Intervention/treatment

AK146D1 for injection

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 for Injection, an Anti-Trop2/Nectin4 Bispecific Antibody-drug Conjugate, in Patients With Advanced Solid Tumors
Actual Study Start Date : 2025-05-05
Estimated Primary Completion Date : 2026-11-05
Estimated Study Completion Date : 2027-05-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 or any treatment with topoisomerase I inhibitor agents.
  • 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.
A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors

Location Details

NCT06929663

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