Sym004 in Patients With Advanced Solid Tumors

NCT01117428 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: Sym004-012009-017119-13
• Study Type: interventional
• Target: 111
• Locations: 3 countries
• Sites: 7

Brief Summary

This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.

Conditions

Metastatic Colorectal Cancer

Keywords

Advanced solid tumors; Metastatic colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  The AEs were used as a primary endpoint. AEs were summarized using descriptive statistics and presented overall by system organ class and preferred term. The frequencies of AEs were presented including number and percentages of participants with events and the total number of events.

  Visit 2 until first follow-up visit (up to 66 weeks)

Secondary Outcomes (3)

• Antitumor Activity

  Up to 62 weeks

• Antitumor Activity Endpoints - Time-to-event Endpoints

  Up to 62 weeks

• Terminal Half-Life (T½)

  See Time Frame in the Outcome Measure Description

Study Arms (1)

Sym004

EXPERIMENTAL

Drug: Sym004

Interventions

Sym004 DRUG

In part A, patients in all dose cohorts will continue weekly treatment with the assigned dose of Sym004 until disease progression. In Part B, patients will continue weekly treatment with the tolerated dose of Sym004 until disease progression. In Part C, patients will receive weekly doses of Sym004 at the dose level below 12 mg/kg i.e. 9 mg/kg until disease progression. In Part D and E, patients will receive doses of Sym004 administered every 2 weeks at dose level 12 mg/kg and 18 mg/kg, respectively until disease progression. In Part F, patients will receive a single loading dose of 9 mg/kg followed by weekly doses of 6 mg/kg.

Sym004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A:
• \. Patients with refractory or recurrent advanced late stage solid tumors without available therapeutic options .
• Part B, C, D, E and F:
• Patients with refractory or recurrent advanced mCRC and wild-type KRAS who have progressed on epidermal growth factor receptor (EGFR) Ab treatment.
• Patients wit confirmed response while on treatment anti-EGFR Ab treatment.
• Documented disease progression during or within 6 months after cessation of anti-EGFR Ab treatment.
• Patients must be willing to have a biopsy performed from a tumor lesion at screening and at Visit 6.
• Part A, B, C, D, E and F:
• Histologically or cytologically confirmed diagnosis of cancer
• Failure and/or intolerance to standard chemotherapy
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

You may not qualify if:

• Patients with clinically symptomatic brain metastases.
• 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
• Diarrhea CTCAE \>1
• Skin rash CTCAE \>1
• Abnormal organ or bone marrow function.
• 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.
• 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 A).
• 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.
• Known HIV positive
• Known active hepatitis B or C

Sponsors & Collaborators

• Symphogen A/S: lead

Study Sites (7)

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

UZ Brussel, Medische Oncologie

Brussels, 1090, Belgium

Location

UZ Gasthuisberg, Digestive Oncology Unit

Brussels, 3000, Belgium

Location

UZ Antwerp, Oncologie

Edegem, 2650, Belgium

Location

Medical Oncology Department, Vall d´Hebron University Hospital

Barcelona, 08035, Spain

Location

Servicio de Oncología Médica, Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• Dienstmann R, Patnaik A, Garcia-Carbonero R, Cervantes A, Benavent M, Rosello S, Tops BB, van der Post RS, Argiles G, Skartved NJ, Hansen UH, Hald R, Pedersen MW, Kragh M, Horak ID, Braun S, Van Cutsem E, Tolcher AW, Tabernero J. Safety and Activity of the First-in-Class Sym004 Anti-EGFR Antibody Mixture in Patients with Refractory Colorectal Cancer. Cancer Discov. 2015 Jun;5(6):598-609. doi: 10.1158/2159-8290.CD-14-1432. Epub 2015 May 11.

  PMID: 25962717 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

futuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

None reported

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Symphogen A/S

info@symphogen.com

+45 8838 2600

Study Officials

• Josep Tabernero, MD, PhD

  Vall d´Hebron University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 5, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 15, 2018
• Results First Posted: July 12, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); BE (3); US (1)