JS212 Combination Therapies in Metastatic Colorectal Cancer
ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- JS212
- Capecitabine
- Bevacizumab
- Oxaliplatin
- JS207
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov