A Study of AK146D1 for Injection in Advanced Solid Tumors

NCT07067567 | Recruiting Phase 1

• 1 other identifier: AK146D1-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities (DLTs)

  DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.

  During the first 3 weeks of treatment.

• Number of participants with adverse events (AEs)

  AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.

  From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.

Secondary Outcomes (8)

• Serum PK concentration of AK146D1

  From pre-dose to the end of the last dose, an average of 6 months.

• Anti-drug antibodies (ADA)

  From pre-dose to 30 days post end of treatment

• Objective Response Rate (ORR) assessed by investigator per RECIST v1.1

  Up to approximately 2 years

• Disease Control Rate (DCR) assessed per RECIST v1.1

  Up to approximately 2 years

• Duration of response (DoR) assessed by the investigator per RECIST v1.1

  Up to approximately 2 years

Study Arms (1)

AK146D1 for injection

EXPERIMENTAL

AK146D1 for injection will be administered in prespecified dose levels

Drug: AK146D1 for injection

Interventions

AK146D1 for injection DRUG

AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate

AK146D1 for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to understand and voluntarily sign the written informed consent form.
• Aged of ≥ 18 years and ≤75 years.
• ECOG PS 0 or 1.
• The expected lifespan is ≥3 months.
• Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
• At least one measurable lesion according to RECIST v1.1.
• Have sufficient organ function.
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception

You may not qualify if:

• Having other active malignancies within 3 years.
• Currently participating in another interventional clinical study.
• Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
• Having received any treatment targeting Trop2 or Nectin4.
• 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.
• Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
• Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
• Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
• Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
• Known to be positive for HIV and other infections.
• Previous history of severe hypersensitivity reactions.
• Live attenuated vaccines were received within 4 weeks.
• Subjects with a history of mental illness and incapacitated or limited capacity.
• Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

SunYat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Ting Liu

CONTACT

+86(0760)8987 3999; clinicaltrials@akesobio.com

Li Zhang, Study Principal Investigator

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 16, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): May 5, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

CN (1)