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

Sponsor
Akeso
Study ID
NCT07669779
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 25, 2026
Start date
Jul 10, 2026
Status verified
Jul 2026
Primary completion
Aug 30, 2027
Completion
May 30, 2029

Study Design

Enrollment
348 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants in this group will receive AK146D1 combined with AK112 and platinum as i.v. infusion.
  • Experimental: Arm B
    Participants in this group will receive AK146D1 combined with osimertinib.
  • Experimental: Arm C
    Participants in this group will receive AK146D1 combined with AK112 as i.v. infusion.

Primary Outcome Measure

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. ]

Central Contacts