Sym004 in Patients With Advanced Solid Tumors

Browse trials for

• Colorectal Neoplasms 5,599

Keywords

• Advanced solid tumors
• Metastatic colorectal Cancer

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 111 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Lead sponsor

Symphogen A/S is the lead sponsor of 14 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Study arms

• Experimental
  Sym004

  Drug: Sym004

Interventions

• DrugSym004

  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.

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.

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

Secondary outcomes

1. Antitumor Activity

   Best Overall Response (OR) on the Full Analysis Set (FAS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, based on central evaluation with confirmatory CT scan or MRI \[Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR): CR + PR\]. Baseline was defined as Visit 2 (pre-infusion). The outcome measure was measured from screening until PD.

   Time frame: Up to 62 weeks

2. Antitumor Activity Endpoints - Time-to-event Endpoints

   Median Progression Free Survival (PFS) was defined as the time interval without PD from start of first infusion until death or documented PD (i.e. at least a 20% increase in the sum of diameters of target lesions) according to RECIST v1.1. Patients who died without confirmed PD were considered as progressed. Patients who died or showed PD more than 21 days after last treatment were censored (i.e. were considered alive without progression on Day 21 after last treatment). Patients without events were censored at date of last scan or 22 days after last treatment, whichever occurred first. Median Overall Survival (OS) was defined as the time from start of first infusion until date of death from any cause. Patients alive at the time of the analysis or prematurely withdrawn from the trial (e.g. lost to follow-up or consent withdrawn) were censored for the OS analysis. In any case of censoring, the date of censoring was the last time point documenting survival status.

   Time frame: Up to 62 weeks

3. Terminal Half-Life (T½)

   For Part A, the endpoint was not calculated. For Parts B, C and F, the endpoint was calculated for each patient following the first and fourth Sym004 infusions. For Parts D and E, the endpoint was calculated for each patient following the first and third Sym004 infusions. T½ was estimated using non-compartmental methods and actual time points. Outcome Measure Time Frame: Parts B, C and F (Weekly dosing): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) until 1 week post-infusion (168-hours) and at Visit 5 (4th dose from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 1 week post-infusion (168-hours). Parts D, E (Dosing every second week): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) to end of 3rd dose (from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 2 weeks post-infusion (336 hours).

   Time frame: See Time Frame in the Outcome Measure Description

Baseline characteristics

Publications

• 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. PubMed 25962717 ↗

Individual participant data

Plan to share: No