NCT07503756RecruitingPhase 2
JS212 Combination Therapies in Metastatic Colorectal Cancer
An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- 25 Apr 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT07503756
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 25 Apr 2026 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent major surgery, radiotherapy, or systemic anticancer therapy prior to study treatment
Other illness
- Active or uncontrolled infections or significant cardiovascular disease
- 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
Lab values
- Prior treatment with EGFR- or HER3-targeted antibody-drug conjugates or topoisomerase I inhibitor-based ADCs
Other
- Participants meeting any of the following criteria will be excluded
- Known active central nervous system metastases
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.