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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JS212

    Drug

    Bispecific antibody-drug conjugate targeting EGFR and HER3

  • Capecitabine

    Drug

    Oral fluoropyrimidine chemotherapy

  • Bevacizumab

    Drug

    Humanized anti-VEGF monoclonal antibody

  • Oxaliplatin

    Drug

    Platinum-based chemotherapy administered intravenously

  • JS207

    Drug

    Bispecific antibody targeting PD-1 and VEGF

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: JS212 + CapecitabineExperimental treatment 2 interventions
Group B: JS212 +Capecitabine+ BevacizumabExperimental treatment 3 interventions
Group C: JS212 + XELOXExperimental treatment 3 interventions
Group D: JS212 + XELOX + JS207Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Investigator-assessed objective response rate (ORR)

Proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.

Time frame
Up to approximately 12 months
2

Safety and Tolerability(AEs)

Incidence and severity of adverse events (AEs) assessed according to CTCAE.

Time frame
From first dose up to approximately 90 days after last dose
3

Safety and Tolerability(SAEs)

Incidence and severity of serious adverse events (SAEs)assessed according to CTCAE.

Time frame
From first dose up to approximately 90 days after last dose
4

Safety and Tolerability(DLTs)

Incidence and severity dose-limiting toxicities (DLTs) assessed according to CTCAE.

Time frame
From first dose up to approximately 90 days after last dose

Secondary outcomes

1

Investigator-assessed objective response rate (DCR)

The DCR is defined as the proportion of subjects whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

Time frame
Up to approximately 12 months
2

Investigator-assessed Duration of Response (DoR)

The DoR is defined as the time from the first occurrence of CR or PR to the first occurrence of Progressive Disease (PD) or death (whichever occurs first). The DoR is only applicable to subjects whose BOR is CR or PR.

Time frame
Up to approximately 12 months
3

Investigator-assessed Progression-Free Survival (PFS)

The PFS is defined as the time from the first administration of the drug to the first documented disease progression (PD) according to the RECIST v1.1 criteria or death due to any disease (whichever occurs first).

Time frame
Up to approximately 12 months
4

Investigator-assessed overall survival (OS)

The OS is defined as the time from the first administration of the drug to death due to any cause.

Time frame
Up to approximately 20 months

Other outcomes

1

The potential biomarker EGFR

To explore the correlation between screening baseline levels of potential biomarker EGFR and clinical efficacy of JS212 combination therapy. Biomarkers will be assessed only at screening. Screening

Time frame
Up to approximately 1 months
2

The potential biomarker HER3

To explore the correlation between screening baseline levels of potential biomarker HER3 and clinical efficacy of JS212 combination therapy. Biomarkers will be assessed only at screening. Screening

Time frame
Up to approximately 1 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Junshi Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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