JS212 Combination Therapies in Metastatic Colorectal Cancer
Recruiting · NCT07503756 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Shanghai East Hospital - Shanghai, Shanghai Municipality, China