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ORR of 71% in EGFR-mutant NSCLC and 83% in c-MET–positive solid tumors in the D1/D8 Q3W dose groups, with no treatment-related ILD or deaths reported in Phase I trial
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Phase I Part A dose escalation complete; Part B dose expansion actively enrolling EGFR-mutant NSCLC and c-MET biomarker–driven cohorts in EGFR wild-type NSCLC, colorectal cancer and beyond
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
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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) .
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.
About Shanghai Allink Biotherapeutics Co.,Ltd
AllinkBio is a clinical-stage biotechnology company dedicated to developing next-generation ADCs and multispecific antibodies for oncology and immunology. Leveraging its proprietary bispecific antibody and ADC technology platforms, the company’s core pipeline includes ALK201, an FGFR2b-targeting ADC, and ALK202, an EGFR/c-MET bispecific ADC, both of which are in global Phase I clinical development across Australia, the United States and China, while Phase II studies are being accelerated concurrently. AllinkBio is also advancing a next-generation ADC payload platform and a masked T-cell engager (TCE) platform, alongside multiple bispecific antibody programs in immunology diseases. Guided by its mission to bring innovative therapies to patients around the world, the company is committed to the relentless innovation of ADCs and multispecific antibodies.
