JS212 Combination Therapies in Metastatic Colorectal Cancer

Summary

This is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC). JS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3 with a topoisomerase I inhibitor payload. Preclinical and early clinical data suggest that dual targeting of EGFR and HER3 may enhance antitumor activity and overcome resistance mechanisms associated with EGFR- or HER2-directed therapies. This study will investigate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (XELOX: capecitabine and oxaliplatin), with or without the PD-1/VEGF bispecific antibody JS207, in patients with mCRC. The study will assess safety, determine the recommended Phase 3 dose (RP3D), and evaluate preliminary antitumor activity of the combination regimens.

Eligibility

Inclusion Criteria:

* 1Participants must meet the following key criteria
* Adults aged 18-75 years with histologically confirmed metastatic colorectal adenocarcinoma
* Microsatellite stable (MSS) or mismatch repair proficient (pMMR) disease
* No prior systemic therapy for advanced or metastatic disease
* At least one measurable lesion according to RECIST v1.1
* ECOG performance status 0-1
* Adequate hematologic, hepatic, renal, and coagulation function
* Life expectancy ≥12 weeks
* Willingness to provide tumor tissue samples for biomarker analyses
* Ability to provide written informed consent

Exclusion Criteria:

* Participants meeting any of the following criteria will be excluded
* Prior treatment with EGFR- or HER3-targeted antibody-drug conjugates or topoisomerase I inhibitor-based ADCs
* Recent major surgery, radiotherapy, or systemic anticancer therapy prior to study treatment
* Active or uncontrolled infections or significant cardiovascular disease
* Known active central nervous system metastases
* History of autoimmune disease requiring systemic therapy
* Significant bleeding disorders or high risk of hemorrhage
* Active viral infections such as uncontrolled hepatitis B, hepatitis C, or HIV
* Any other serious medical or psychiatric condition that may interfere with study participation

Conditions2

Interventions5

Related trials

• - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases — Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• 5FU/LV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer. — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer — Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies — Shanghai Junshi Bioscience Co., Ltd.
• A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma — BioNTech SE
• A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer — British Columbia Cancer Agency
• A Multi-Arm, Platform Trial For Relapsed Neuroblastoma — University of Birmingham
• A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients — Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Browse More Trials