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
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
Treatments tested in this trial
- MRG007
- 5-Fluorouracil / Leucovorin Calcium
- Bevacizumab
- Oxaliplatin
- PD-1/VEGF antibody
- Capecitabine
Treatment groups
316 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov