SCT200 / Sinocelltech - LARVOL DELTA

Patients with AML with an IDH2 R172K mutation have improved overall survival with venetoclax + azacitidine as compared to those with IDH2 R140Q mutations (ASH 2025) - "Investigating this further, we found that patients with R172K mutations received a SCT earlier in their disease course (R172K time to transplant 86 days, inter-quartile range (IQR) 71-124, versus R140Q time to SCT 200 days, IQR 111-280, Wilcoxon p-value 0.0077). Our results support prior evidence that the two predominant IDH2 mutations are biologically distinct; furthermore, we show they have a differential impact on outcomes with ven/aza. In contrast to recent findings with response to intensive chemotherapy, in our cohort, patients with R172K IDH2 mutations responded more quickly to ven/aza, had deeper responses, and were more likely to proceed to SCT. This result contrasts with a recent study showing patients with IDH2 R172K mutations had no difference in OS when treated with intensive chemotherapy (Salman et al Blood Advances 2025), suggesting an important difference compared with ven/aza in patients with IDH2 R172K mutations."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • DNMT3A • FLT3 • IDH1 • IDH2 • NPM1

An anti-PD-1 antibody (SCT-I10A) plus anti-EGFR antibody (SCT200) and chemotherapy for RAS/BRAF wild-type metastatic colorectal cancer: A phase Ib study. (PubMed, Cancer Lett) - "Immunotherapy has demonstrated limited efficacy against microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). Oxaliplatin may induce greater immune activation, with GZMA and CXCL13 serving as potential prognostic biomarkers. Thus, combining immunotherapy, EGFR inhibitors, and XELOX represents an optimal therapeutic strategy for mCRC."

IO biomarker • Journal • P1 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF • CXCL13 • GZMA

Anti-PD-1 antibody (SCT-I10A) plus anti-EGFR antibody (SCT200) in patients with advanced esophageal squamous cell carcinoma: A multicenter, open-label, phase 1b clinical trial. (PubMed, Cancer) - P1 | "SCT-I10A plus SCT200 demonstrated durable antitumor activity with a manageable safety profile in previously treated patients with advanced ESCC, even in patients who had previously failed anti-PD-(L)1 therapy."

Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody. (PubMed, Cancer Lett) - P1 | "SCT200 in combination with paclitaxel or docetaxel shows promising efficacy in patients with R/M HNSCC following platinum-based chemotherapy and PD-1 inhibitors, warranting further investigation. ClinicalTrials.gov identifier: NCT05552807."

Journal • P1 data • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy, safety and genomic analysis of SCT200, an anti-EGFR monoclonal antibody, in patients with fluorouracil, irinotecan and oxaliplatin refractory RAS and BRAF wild-type metastatic colorectal cancer: a phase Ⅱ study. (PubMed, EBioMedicine) - "SCT200 exhibited promising clinical efficacy and manageable safety profiles in RAS and BRAF wild-type mCRC patients progressed on fluorouracil, irinotecan and oxaliplatin treatment. The baseline ctDNA and ctDNA clearance status at the 7th week after the first dose of SCT200 administration before receiving SCT200 could be a potential prognostic biomarker for RAS and BRAF wild-type mCRC patients with SCT200 therapy."

Journal • Metastases • Colorectal Cancer • Dermatitis • Dermatology • Gastrointestinal Cancer • Immunology • Oncology • Solid Tumor • BRAF • MET • MYC • RAS

Phase Ib study of anti-EGFR antibody (SCT200) in combination with anti-PD-1 antibody (SCT-I10A) for patients with RAS/BRAF wild-type metastatic colorectal cancer. (PubMed, Cancer Biol Med) - P1 | "SCT200 combined with SCT-I10A demonstrated promising efficacy in previously treated RAS/BRAF wt mCRC patients with an acceptable safety profile. Further head-to-head studies with larger sample sizes are needed to validate whether the efficacy and safety of combined anti-EGFR and anti-PD-1 therapy are superior to anti-EGFR monotherapy in the third-line setting. (Registration No. NCT04229537)."

Combination therapy • Journal • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • RAS

Safety, pharmacokinetics and efficacy of SCT200, an anti-EGFR monoclonal antibody in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer: a phase I dose-escalation and dose-expansion study. (PubMed, BMC Cancer) - P1 | "SCT200 showed favorable safety, PK profile, and preliminary efficacy for patients with wild-type KRAS/NRAS/BRAF mCRC."

Journal • P1 data • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS • NRAS

SCT200 in Combination With SCT-I10A/Paclitaxel/Docetaxel in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Sinocelltech Ltd.

Combination therapy • IO biomarker • New P1 trial • Head and Neck Cancer • Immune Modulation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma. (PubMed, Cancer Biol Med) - "SCT200 monotherapy as the second- or further-line treatment for advanced ESCC showed favorable efficacy, with an acceptable safety profile. TP53 mutation abundance might serve as a potential predictive biomarker."

Clinical • IO biomarker • Journal • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • TP53

[VIRTUAL] Efficacy and safety of anti-EGFR monoclonal antibody (SCT200) as third-line or further treatment in advanced lung squamous cell cancer. (ASCO 2021) - P1 | "In this trial, a clinical benefit in OS was observed in the high dose group . SCT200 was shown to be safe and well tolerated in all patients . Our study indicated that SCT200 could serve as a potential single treatment or in combination with other therapy for advanced LSCC."

Clinical • Anemia • Hematological Disorders • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma

[VIRTUAL] Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell cancer. (ASCO 2021) - P1/2 | "SCT200 monotherapy as second- or further-line for advanced ESCC showed favorable efficacy, with an acceptable safety profile . TP53 mutation abundance might serve as potential predictive biomarkers."

Clinical • IO biomarker • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • TP53

Synthesis, characterization, and targeted chemotherapy of SCT200-linker-monomethyl auristatin E conjugates. (PubMed, Eur J Med Chem) - "Moreover, the novel linkers designed in this study can be linked with other antibodies to treat other types of cancer. Overall, these findings provide important insights into the application of SCT200-based linkers in ADCs."

Journal • Oncology • Solid Tumor • CTSB • EGFR

SCT200 Plus Platinum-based Chemotherapy in Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=25; Active, not recruiting; Sponsor: Sinocelltech Ltd.; Trial primary completion date: Mar 2020 ➔ Jun 2020

Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Sinocelltech Ltd.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Aug 2021 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date

Safety and Efficacy of SCT200 in Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=40; Active, not recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Active, not recruiting; Trial completion date: Feb 2020 ➔ May 2020; Trial primary completion date: May 2019 ➔ Feb 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

SCT200 Plus Platinum-based Chemotherapy in Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=25; Active, not recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P1 trial