Clinical trial · Interventional
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX07 | Drug | — | UNRESOLVED |
| HLX10 | Drug | Serplulimab | ALIAS |
| mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A：1L treatment
- description
- HLX07 \* 1000 mg+HLX10\* 200mg +mFOLFOX6, IV, Q2W
- interventionNames
- Drug: HLX07
- Drug: HLX10
- Drug: mFOLFOX6
- type
- EXPERIMENTAL
- label
- B：≥2L treatment
- description
- HLX07 \*1000 mg monotherapy,IV, Q2W
- interventionNames
- Drug: HLX07
Primary outcomes (2)
- measure
- ORR
- timeFrame
- up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>=18Y and ≤75Y * Good Organ Function * Expected survival time ≥ 3 months * mCRC that have been diagnosed histologically * KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue * ECOG score 0-1; Exclusion Criteria: * HIV infection * Active clinical severe infection; * A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
References
Publications (0)
Data not yet available