A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer
NCT07669779 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 348
Last updated 2026-07-14
Summary
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.
Conditions
- Advanced Non Small Cell Lung Cancer (NSCLC)
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 is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-10
- Primary Completion
- 2027-08-30
- Completion
- 2029-05-30
Countries
- China
Study Locations
More Related Trials
-
Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.
NCT07603791 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer
NCT07623356 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC
NCT06769295 ·Status: RECRUITING ·Phase: PHASE2
-
Multidisciplinary Treatment of Stage III ALK+ NSCLC With Neoadjuvant Alectinib and Chemotherapy
NCT07573696 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
NCT05377658 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Combination Therapy in NSCLC
NCT04544644 ·Status: UNKNOWN ·Phase: PHASE2
-
AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment
NCT07158840 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
NCT05840016 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC
NCT05247684 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer
NCT03866980 ·Status: TERMINATED ·Phase: PHASE3
-
A Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC
NCT04736823 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
NCT07034391 ·Status: RECRUITING ·Phase: PHASE2
-
A Trial of AK104 Plus Anlotinib in NSCLC
NCT04646330 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Efficacy and Safety of KN046 Combined With Axitinib
NCT06020352 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer
NCT05420220 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2 Study of ABSK043 Combined With Osimertinib
NCT07710612 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Phase 3 Clinical Study of AK112 for NSCLC Patients
NCT05184712 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Adjuvant Chemotherapy for High-Risk Pathologic Stage I Non-Squamous NSCLC
NCT07250360 ·Status: COMPLETED
-
CM082 and JS001 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC).
NCT03848611 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)
NCT07640789 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer
NCT07172412 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLC
NCT06478043 ·Status: COMPLETED ·Phase: PHASE2
-
PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC
NCT07645222 ·Status: RECRUITING ·Phase: PHASE1
-
Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants.
NCT07742956 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%
NCT07215962 ·Status: ACTIVE_NOT_RECRUITING