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Recruiting NCT07669779

A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer

Phase II Interventional Advanced Non Small Cell Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AK146D1 for injection, AK112 Injection, Platinum chemotherapy, Osimertinib.
Who it may be relevant to
Registry conditions: Advanced Non Small Cell Lung Cancer (NSCLC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of AK146D1 in Combination With AK112 or Other Anticancer Therapies in Patients With Advanced Non-Small Cell Lung Cancer

Overview

This is a phase II clinical study evaluating the safety, tolerability, pharmacokinetics and antitumor efficacy of AK146D1 in combination with AK112 or other anticancer therapies in patients with advanced Non-Small Cell Lung Cancer.

Interventions

  • Drug AK146D1 for injection
    AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate.
  • Drug AK112 Injection
    AK112 is a PD-1/VEGF bispecific antibody.
  • Drug Platinum chemotherapy
    Carboplatin or cisplatin will be administered.
  • Drug Osimertinib
    Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

Primary outcome measures

  • Number of participants with dose limiting toxicities (DLTs) [Time frame: During the first 3 weeks of treatment in Safety Run-in Phase.]
  • Number of participants with adverse events (AEs) [Time frame: 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.]
  • Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years.]
Secondary outcome measures (7)
  • Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years.]
  • Disease Control Rate (DCR) assessed per RECIST v1.1 [Time frame: Up to approximately 2 years.]
  • Duration of response (DoR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years.]
  • Time to response (TTR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years.]
  • Overall survival (OS) [Time frame: Up to approximately 2 years.]
  • Serum PK concentration of AK146D1 and AK112 [Time frame: From pre-dose to the end of the last dose, an average of 6 months.]
  • Anti-drug antibodies (ADA) [Time frame: From pre-dose to 30 days post end of treatment.]

Eligibility criteria

Inclusion criteria

  • 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.
  • Patients with histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) who are not eligible for curative surgical resection and cannot receive definitive concurrent or sequential chemoradiotherapy.
  • At least one measurable non-brain 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.

Exclusion criteria

  • NSCLC mixed with a component of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma.
  • 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.
  • Prior chemotherapy or antibody-drug conjugate (ADC) therapy targeting topoisomerase I inhibitors.
  • Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks (or 5 half-lives of the drug, whichever is longer) prior to the first dose.
  • Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 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.
  • Receipt of systemic anti-infective therapy within 2 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • SunYat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT07669779 · AK146D1-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗