A Study of AK157D1 for Injection in Advanced Solid Tumors

NCT07847281 | Not Yet Recruiting Phase 1

• 1 other identifier: AK157D1-101
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 3

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 AK157D1 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 (13)

• Area under curve (AUC)

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

• Maximum Concentration (Cmax)

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

• Peak Time (Tmax)

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

• The terminal elimination half-life (t1/2)

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

• Clearance (CL)

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

Study Arms (1)

AK157D1 for injection

EXPERIMENTAL

AK157D1 for injection will be administered in prespecified dose levels

Drug: AK157D1 for injection

Interventions

AK157D1 for injection DRUG

IV infusion, administered on Day 1 of each cycle, Q3W, continuous treatment

AK157D1 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.
• 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.
• ECOG PS 0 or 1.
• The expected lifespan is ≥3 months.
• Have sufficient organ function.
• Females participants 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:

• Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
• Having other active malignancies within 3 years.
• Having received major surgical operations within 4 weeks before the first administration.
• Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
• Participants with a history of mental illness and incapacitated or limited capacity.
• Having received systemic anti-tumor treatment within 3 weeks.
• Having received any treatment targeting B7H3.
• Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
• Previous history of severe hypersensitivity reactions.
• Participants with active autoimmune diseases requiring systemic treatment within 2 years.
• Known to be positive for HIV and other infections.
• Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
• Live attenuated vaccines were received within 4 weeks.
• Currently participating in another interventional clinical study.
• Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.

Sponsors & Collaborators

• Akeso: lead

Study Sites (3)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Zhifang Yao, M.D.

CONTACT

+86-0760-89873999; clinicaltrails@akesobio.com

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: September 21, 2026
• First Posted: September 29, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): September 15, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

CN (3)