New cancer drug targets two proteins at once in early trial
NCT ID NCT07067567
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase study tests a new drug called AK146D1 in 200 adults with advanced solid tumors that have worsened after standard treatments. The drug is designed to attach to two proteins (Trop2 and Nectin4) on cancer cells and deliver a toxic payload. The main goals are to check safety and find the right dose, while also looking for signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK146D1 (a bispecific antibody-drug conjugate targeting Trop2 and Nectin4 proteins on cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial, so the drug may not be safe or effective. Side effects could be serious, and it is not yet known if it will shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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SunYat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors