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An Open-label, Multi-center Phase I Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Sym004 in Patients With Advanced Solid Tumors

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

An Open-label, Multi-center Phase I Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Sym004 in Patients With Advanced Solid Tumors

Inclusion Criteria:

Part A:

1. Patients with refractory or recurrent advanced late stage solid tumors without
available therapeutic options .

Part B, C, D and E:

1. Patients with refractory or recurrent advanced mCRC and wild-type KRAS who have
progressed on EGFR Ab treatment.

2. No more than 4 previous chemotherapy regimens.

3. Patients must be willing to have a biopsy performed from a tumor lesion at screening
and at Visit 6.

Part A, B, C, D and E:

1. Histologically or cytologically confirmed diagnosis of cancer

2. Failure and/or intolerance to standard chemotherapy

3. Life expectancy of at least 3 months

4. ECOG performance status ≤2

Exclusion Criteria:

1. Patients with clinically symptomatic brain metastases.

2. Received the following treatments prior to Visit 2:

- Cytotoxic or cytostatic anti-cancer chemotherapy within 4 weeks

- Total resection or irradiation of the target lesion

- Antibody therapy within 4 weeks and vaccines within 12 weeks

- Tyrosin kinase inhibitors within 4 weeks

- Any investigational agent within 4 weeks

3. Diarrhea CTCAE >1

4. Skin rash CTCAE >1

5. Abnormal organ or bone marrow function.

6. Use of immunosuppressive agents for the past 4 weeks prior to trial start, including
systemic corticosteroids used at doses above 20mg/day of prednisolone or equivalent.

7. History of other malignancy within 5 years prior to trial start, with the exception
of basal cell carcinoma of the skin and carcinoma in situ of the cervix (not in Part

8. Active severe infection, any other concurrent disease or medical conditions that are
deemed to interfere with the conduct of the trial as judged by the investigator.

9. Known HIV positive

10. Known active hepatitis B or C

11. Patients with known uncontrolled allergic conditions or allergy to the study drug
and/or their components.

12. Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within six months from Visit 1, congestive heart failure, and arrhythmia
requiring therapy, with the exception of extra systoles or minor conduction
abnormalities and controlled and well treated chronic atrial fibrillation.

13. Significant concurrent, uncontrolled medical condition evaluated by the investigator
to interfere with effect of the trial drug.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events

Outcome Description:

DLTs (DLT period of 4 weeks after first dose in each patient) along with; incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) during the entire trial period.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Josep Tabernero, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Vall d'Hebron BCN ES


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

February 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • Advanced solid tumors
  • Metastatic colorectal Cancer
  • Colorectal Neoplasms



South Texas Accelerated Research Therapeutics (START)San Antonio, Texas  78229