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Clinical Trials in China / NCT07503756
Recruiting Phase 2

JS212 Combination Therapies in Metastatic Colorectal Cancer

NCT07503756 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Junshi Bioscience Co., Ltd
Phase
Phase 2
Started
2026-04-25
Last updated
2026-05-05

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

JS212 →Capecitabine →Bevacizumab →Oxaliplatin →JS207 →

JS212: Bispecific antibody-drug conjugate targeting EGFR and HER3

Capecitabine: Oral fluoropyrimidine chemotherapy

Bevacizumab: Humanized anti-VEGF monoclonal antibody

Oxaliplatin: Platinum-based chemotherapy administered intravenously

JS207: Bispecific antibody targeting PD-1 and VEGF

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Investigator-assessed objective response rate (ORR) — Up to approximately 12 months
    Proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
  • Safety and Tolerability(AEs) — From first dose up to approximately 90 days after last dose
    Incidence and severity of adverse events (AEs) assessed according to CTCAE.
  • Safety and Tolerability(SAEs) — From first dose up to approximately 90 days after last dose
    Incidence and severity of serious adverse events (SAEs)assessed according to CTCAE.
  • Safety and Tolerability(DLTs) — From first dose up to approximately 90 days after last dose
    Incidence and severity dose-limiting toxicities (DLTs) assessed according to CTCAE.
  • Maximum Tolerated Dose (MTD) — Up to approximately 6 months
    Determination of MTD for JS212 combination therapy.
  • Recommended Phase 3 Dose (RP3D) — Up to approximately 6 months
    Determination of RP3D for JS212 combination therapy.

Trial sites (1)

FacilityCityRegionStatus
Shanghai East Hospital Shanghai Shanghai Municipality Recruiting

On this site

📄 Avastin (bevacizumab) drug profile →

More Shanghai Junshi Bioscience Co., Ltd. trials in China

JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. Recruiting
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour Recruiting
JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma Recruiting
A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC) Recruiting
A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer Recruiting

Other trials for the same condition

Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer Recruiting
A Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC) Recruiting
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer Recruiting
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Active, not recruiting
ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07503756 on ClinicalTrials.gov ↗ ← All trials in China