AK138D1 / Akesobio - LARVOL DELTA

A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=265 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Akeso IO2.0 + ADC2.0 Strategy Makes Another Advancement: First Patient Dosed in Phase Ib/II Study of HER3 ADC (AK138D1) Combined with Ivonescimab in Lung Cancer (PRNewswire) - "The study aims to evaluate the potential of Akeso's IO2.0 + ADC2.0 regimen across multiple settings in advanced NSCLC, including: first-line treatment, treatment after EGFR-TKI resistance, and treatment after immuno-chemotherapy resistance....The combination of AK138D1 with ivonescimab is expected to further amplify ivonescimab's immune-activating effects."

Trial status • Non Small Cell Lung Cancer

Akeso's Next-Generation HER3 ADC AK138D1 Combined with Ivonescimab: First Patient Enrolled in Phase Ib/II Breast Cancer Study, Advancing the IO2.0 + ADC2.0 Strategy (PRNewswire) - "The AK138D1-202 study focuses on the two major breast cancer subtypes with the greatest unmet need: hormone receptor-positive, HER2-negative (HR+/HER2-) disease, which accounts for approximately 65% of all breast cancers, and triple-negative breast cancer (TNBC), which represents 10-20% of cases."

Enrollment status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=265 | Not yet recruiting | Sponsor: Akeso

Monotherapy • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=286 | Not yet recruiting | Sponsor: Akeso

Monotherapy • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

Akeso, Inc…announced today that it has received clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate Phase II clinical trials for AK146D1, a first-in-class Trop2 /Nectin4 bispecific antibody-drug conjugate (ADC), and AK138D1, an innovative HER3-targeting ADC. (The Manila Times) - "The studies will evaluate these two novel ADC candidates in combination with the Company's pioneering immuno-oncology (IO) 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), as well as other proprietary high-potential anti-tumor assets, including AK117 (anti-CD47 monoclonal antibody) and AK109 (anti-VEGF monoclonal antibody), across a spectrum of advanced solid tumors....These Phase II studies will leverage the cadonilimab and ivonescimab as foundational backbone therapies, capitalizing on their validated clinical profiles in checkpoint blockades and dual VEGF/PD-1 inhibition."

New P2 trial • Solid Tumor

A Study of AK138D1 in Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Akeso

New P1 trial • Oncology • Solid Tumor

A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Akeso Announces First ADC Drug Clinical Trial, Marking a New Era for “IO 2.0 + ADC“ Strategy (PRNewswire) - "Akeso, Inc. (9926.HK) announced the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies in Australia. AK138D1, a self-developed and differentiated HER3-targeting ADC (antibody-drug conjugate), is Akeso's first ADC drug to enter clinical studies."

Trial status • Solid Tumor

A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Akeso

Metastases • New P1 trial • Oncology • Solid Tumor

Kangfang's semi-annual report: the first self-developed ADC surfaced [Google translation] (Sina Corp) - "Another highlight in the semi-annual report is that Kangfang announced its first self-developed ADC candidate drug AK138D1-an IND application has been submitted to CDE for the treatment of advanced malignant tumors....It is expected that in the second half of this year, AK138D1 will enter the Phase I clinical dose escalation."

New P1 trial • Oncology • Solid Tumor