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A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer

ConditionAdvanced Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Biopharma Co., Ltd.

About this trial

This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Expected survival of ≥ 3 months.

Tumor tissue specimens must be provided for relevant biomarker testing. If archived tissue specimens are unavailable, a new biopsy must be performed.

Pathologically confirmed, unresectable locally advanced or metastatic colorectal adenocarcinoma.

At least one measurable lesion according to RECIST v1.1 criteria. Measurable lesions should not have received prior radiotherapy; however, measurable lesions located within a prior radiation field or after local therapy may be selected as target lesions if disease progression is confirmed.

Disqualifiers

Trial participants with known deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H).

Trial participants with synchronous or multiple primary malignancies.

Residual toxicity ≥ Grade 2 resulting from prior anti-tumor therapy.

Symptomatic central nervous system (CNS) metastases and/or leptomeningeal metastases.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MRG007

    Drug

    MRG007 will be administrated as specified in the protocol.

  • 5-Fluorouracil / Leucovorin Calcium

    Drug

    5-Fluorouracil / Leucovorin Calcium will be administrated as specified in the protocol.

  • Bevacizumab

    Drug

    Bevacizumab will be administrated as specified in the protocol.

  • Oxaliplatin

    Drug

    Oxaliplatin will be administrated as specified in the protocol.

  • PD-1/VEGF antibody

    Drug

    PD-1/VEGF antibody will be administrated as specified in the protocol.

  • Capecitabine

    Drug

    Capecitabine will be administrated as specified in the protocol.

Treatment groups

316 Participants
are divided into 4 treatment groups
Group A: MRG007 + 5-Fluorouracil / Leucovorin Calcium + BevacizumabExperimental treatment 3 interventions
Group B: MRG007 + 5-Fluorouracil / Leucovorin Calcium + Oxaliplatin + BevacizumabExperimental treatment 4 interventions
Group C: MRG007 + 5-Fluorouracil / Leucovorin Calcium + Oxaliplatin + PD-1/VEGF antibodyExperimental treatment 4 interventions
Group D: MRG007 + Capecitabine + Oxaliplatin + BevacizumabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity (DLT)

Time frame
From the first dose to 30 days after the last dose
2

Serious Adverse Events (SAEs)

Time frame
From the first dose to 30 days after the last dose
3

Adverse Event (AE)

Time frame
From the first dose to 30 days after the last dose
4

Recommended Phase 2 Dose(RP2D) and/or Maximum Tolerated Dose (MTD)

Time frame
From the first dose to 30 days after the last dose

Secondary outcomes

1

Serum Concentration

Serum Concentration of ADC, TAb, free payload will be measured.

Time frame
up to 2 years
2

Anti-Drug Antibody (ADA)

The proportion of patients with positive ADA results.

Time frame
up to 2 years
3

Neutralizing antibody (NAb)

The proportion of patients with positive NAb results.

Time frame
up to 2 years
4

Duration of Response (DOR)

Time frame
Through study completion, an average 2 years

Other outcomes

Sponsors and contacts

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

Lepu Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: