NCT07503756 JS212 Combination Therapies in Metastatic Colorectal Cancer
| NCT ID | NCT07503756 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Condition | Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-25 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-04-25 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Zhenyu Xu, Doctor
STUDY DIRECTOR
Medical Director
Frequently Asked Questions
Who can join the NCT07503756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07503756 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07503756 currently recruiting?
Yes, NCT07503756 is actively recruiting participants. Contact the research team at ying_zhang2@junshipharma.com for enrollment information.
Where is the NCT07503756 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07503756 clinical trial?
NCT07503756 is sponsored by Shanghai Junshi Bioscience Co., Ltd.. The principal investigator is Zhenyu Xu, Doctor at Medical Director. The trial plans to enroll 80 participants.
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