AK146D1 injection for adults with advanced solid tumors

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 first-in-human, Phase 1 interventional study of AK146D1 given by injection to adults with unresectable advanced solid tumors. The trial will enroll patients with measurable disease and good performance status (ECOG 0-1) who have progressed on or are intolerant of standard therapies, and will monitor safety, tolerability, pharmacokinetics, immunogenicity, and early signs of antitumor activity. Response will be measured using RECIST v1.1 and participants must have adequate organ function and agree to contraception if applicable. Patients with active central nervous system metastases or recent other active malignancies are excluded unless specified as stable or asymptomatic.

Why it matters

Who can join: the full rules

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.

Where it's running

• Scientia Clinical Research
  Sydney, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Hui Gan — Austin Health
• Study coordinator: Ting Liu
• Email: clinicaltrials@akesobio.com
• Phone: +86(0760)8987 3999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• AK157D1 injection for advanced solid tumors

  A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

  Recruiting Phase 1 Akeso · Harbin, Heilongjiang and 2 other locations · NCT07847281

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• MK-2010 alone or with other treatments for advanced solid tumors

  This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.

  Recruiting at 7 sites Phase 2 Merck Sharp & Dohme LLC · Belleville, New Jersey and 6 other locations · NCT07793942

• Whole-Body Infrared Heating for Advanced Solid Tumors

  This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.

  Recruiting Zhejiang Hospital · Hangzhou, Zhejiang · NCT07793214

• MK-2010 with Sac-TMT in advanced solid tumors

  This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

  Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

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.