Clinical trial · Interventional
Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies
An Open-label, Multicenter, Phase 1a/2a Trial Investigating the Safety, Tolerability and Antitumor Activity of Multiple Doses of Sym013, a mAb Mixture Targeting EGFR, HER2 and HER3, in Patients With Advanced Epithelial Malignancies
NCT02906670CI-TRIAL-00046843terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study is to see if Sym013 is safe and effective for patients with advanced epithelial malignancies without available therapeutic options.
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 |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sym013 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (14)
- type
- EXPERIMENTAL
- label
- 1 mg/kg Q1W
- description
- Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
- interventionNames
- Drug: Sym013
- type
- EXPERIMENTAL
- label
- 2 mg/kg Q1W
- description
- Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.
- interventionNames
- Drug: Sym013
- type
- EXPERIMENTAL
- label
- 4 mg/kg Q1W
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Main inclusion criteria all patients, Part 1 and Part 2: * Male or female, at least 18 years of age at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 * Life expectancy \>3 months assessed during Screening * Documented (histologically- or cytologically-proven) epithelial malignancy that is locally advanced or metastatic, having received all therapy known to confer clinical benefit Additional inclusion criteria applicable to Part 2 ONLY: * Epithelial malignancy (tumor types to be determined), measurable according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to C1/D1 * Willingness to undergo a pre-and post-dosing biopsy (total of 2 biopsies) from primary or metastatic tumor site(s) considered safe for biopsy Exclusion Criteria: * Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives (whichever is shortest) prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1. * Part 2 ONLY: Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following radiotherapy * Immunosuppressive or systemic hormonal therapy (\>10 mg daily prednisone equivalent) within 2 weeks prior to C1/D1 with exceptions * Use of hematopoietic growth factors within 2 weeks prior to C1/D1 * Active second malignancy or history of another malignancy within the last 3 years, with allowed exceptions * Central nervous system (CNS) malignancies including: 1. Primary malignancies of the CNS 2. Known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS metastatic involvement for which treatment is required * Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy * Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure * Non-healing wounds on any part of the body * Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to C1/D1, unless adequately treated and stable * Active uncontrolled bleeding or a known bleeding diathesis * Significant gastrointestinal abnormalities * Significant cardiovascular disease or condition * Abnormal hematologic, renal or hepatic function
References
Publications (1)
- DERIVEDBerlin J, Tolcher AW, Ding C, Whisenant JG, Horak ID, Wood DL, Nadler PI, Hansen UH, Lantto J, Skartved NJO, Pedersen MW, Patnaik A. First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies. Invest New Drugs. 2022 Jun;40(3):586-595. doi: 10.1007/s10637-022-01217-7. Epub 2022 Feb 3. PMID 35113285