On September 14, 2026 Shanghai Allink Biotherapeutics Co.,Ltd ("Allink"), a clinical-stage biotechnology company dedicated to developing next-generation antibody-drug conjugates (ADCs) and multispecific antibodies for oncology and immunology, reported the presentation of initial data from the first-in-human Phase I clinical trial (NCT06707610) of ALK202, its internally discovered and potential best-in-class EGFR/c-MET bispecific ADC.The data were featured in a poster tour presentation (Abstract #PT2.01.03) on September 14, 2026, at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, South Korea.

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The study is led by Principal Investigator Professor Caicun Zhou of Shanghai East Hospital, Tongji University School of Medicine, with Professor Fei Zhou as first author, and is being conducted across multiple clinical sites in China, Australia and the United States.

Study Design and Patient Baseline

ALK202 is under investigation in an open-label, international, multicenter Phase I study in patients with advanced solid tumors refractory to standard therapy. The dose-escalation stage (Part A) evaluated ALK202 administered every three weeks (Q3W; 1.5–6.4 mg/kg) and on Days 1 and 8 of every three-week cycle (D1/D8 Q3W; 3.2–3.6 mg/kg). The dose-expansion stage (Part B) is further evaluating the safety and efficacy profile of selected doses (2.8 or 3.2 mg/kg D1/D8 Q3W) in patients with EGFR-mutant non-small cell lung cancer (NSCLC), EGFR wild-type c-MET–positive NSCLC, c-MET–positive colorectal cancer and other solid tumors.
At the June 24, 2026 data cutoff, 71 patients had received dosing. The enrolled group represented a heavily pretreated, refractory advanced population: the median age was 61 years (range, 33–80), 90% had metastatic disease and 82% had received two or more prior lines of therapy (including 54% with three or more).
Manageable Safety Profile
Safety analysis of the 71 patients showed that treatment-related adverse events (TRAEs) occurred in 96% of patients, with Grade ≥3 TRAEs in 31%. The most common adverse events were hematologic and gastrointestinal toxicities, which were generally manageable. Notably, EGFR target-associated toxicities were infrequent, with low rates of rash (4%) and pruritus (7%). Overall, the treatment demonstrated a favorable tolerability profile, only 3% of patients discontinued treatment due to TRAEs, and no treatment-related deaths or interstitial lung disease (ILD) events were reported.

Encouraging Efficacy Data
EGFR-mutant NSCLC population (n=20): The best objective response rate (ORR) was 40% and the disease control rate (DCR) was 85%. In the D1/D8 Q3W dose groups, the ORR reached 71% (5/7) .

c-MET–positive (IHC 2+/3+ ≥50%) solid tumor population (n=20): The ORR was 40% and the DCR was 95%. In the D1/D8 Q3W dose groups, the ORR reached 83% (5/6) .

"The Phase I data for ALK202 have demonstrated clear efficacy signals in patients with c-MET–positive solid tumors and EGFR-mutant NSCLC," said Dr. Hui Feng, Founder and Chief Executive Officer of Allink Biotherapeutics. "We will accelerate enrollment in the dose-expansion stage to further explore c-MET as a biomarker-driven population across EGFR wild-type NSCLC, colorectal cancer and additional solid tumors. At the same time, these monotherapy results in late-line NSCLC provide a stronger data foundation for advancing combination treatment strategies into first-line setting. We believe that, with its differentiated molecular design and growing body of international multicenter clinical evidence, ALK202 has the potential to become a best-in-class EGFR/c-MET bispecific ADC, bringing meaningful benefit to patients in China and around the world as early as possible."

About ALK202

ALK202 is Allink’s internally discovered first-in-class EGFR/c-MET bispecific antibody-drug conjugate, comprising the topoisomerase I inhibitor exatecan conjugated via a cleavable, highly hydrophilic linker. Its antitumor activity is mediated through multiple mechanisms: dual blockade of the EGFR and c-MET pathways, antibody-dependent cellular cytotoxicity (ADCC), targeted payload delivery, and a bystander killing effect. EGFR and c-MET are key oncogenic drivers and resistance-associated targets in NSCLC and multiple other solid tumors. ALK202 has the potential to offer a new treatment option for patients with EGFR-mutant NSCLC and solid tumors with high c-MET expression. A Phase I clinical study of ALK202 in advanced solid tumors (NCT06707610) is actively advancing, and a Phase II clinical study in lung cancer (NCT07603791) is also underway.

(Press release, Shanghai Allink Biotherapeutics, SEP 14, 2026, View Source [SID1234670857])