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.
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.
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