Clinical trial · Interventional
Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancer
A Prospective, Open-label, Dose Escalation (Part A) and Cohort Expansion (Part B) Phase 1 Study to Investigate the Safety, Tolerability, and Immunogenicity and to Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancers
- 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)
The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2 Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous (IV) infusion to patients with stage IV solid tumors. The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118 and explore prognostic biomarkers and pharmacodynamic biomarkers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GC1118 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single group assignment
- description
- GC1118 recombinant human anti-EGFR antibody
- interventionNames
- Biological: GC1118
Primary outcomes (3)
- measure
- Occurrence of Dose Limiting Toxicity (DLT)
- timeFrame
- Approx. 6 months
- measure
- Frequency of Adverse Events
- timeFrame
- Approx. 6 months
- measure
- Changes in safety parameters, laboratory values, vital signs and physical examinations
- timeFrame
- Approx. 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to sign a written informed consent * Nineteen (19) years of age or older * For Part A and Part C, all stage IV advanced solid cancers For Part B, stage IV of gastric cancer, colorectal cancer or other cancer * Cohort1: Metastatic CRC (K-RAS wild), No prior treatment with EGFR antibody therapeutics * Cohort2: Metastatic CRC (K-RAS wild), Progressed over EGFR antibody therapeutics * Cohort3: Advanced gastric or gastroesophageal junction cancer(EGFR++ or +++ /HER2-) * For Part A and Part C, refractory solid tumors to conventional therapy (Progressive disease during or after previous conventional therapy) * Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1 * Life expectancy of greater than or equal to 3 months * Availability of a new tumor biopsy or able to obtain unstained slides of tumor within 3 years * For Part B, at least one measurable tumor mass by RECIST v1.1 * Acceptable laboratory parameters * If all AEs caused by the previous anti-cancer therapies including surgery, chemotherapy and radiation therapy have recovered to CTCAE grade 1 or below (except alopecia) Exclusion Criteria: * Has had any major surgery or any therapy within the last 4 weeks and/or not recovered from prior therapy * Has had chemotherapy, surgery or radiotherapy within the previous 4 weeks * Confirmed brain metastases * Chronic Hepatitis C or known HIV positive patients * Liver Cirrhosis or active hepatitis B virus (HBV) carrier * Clinically significant interstitial pulmonary disease * Has received prior treatment with cetuximab or anti-EGFR antibody therapy is not permitted in Part B(however, allowed in Part A and Part C) * Clinically significant cardiac disease or impaired cardiac function * Acute or subacute intestinal obstruction or Inflammatory bowel disease * Has had immunotherapy, chemotherapy or hormonal therapy prohibited as per study protocol * Has participated in any study using an investigational drug during the previous 4 weeks * Known hypersensitivity to the study drug * History of second primary malignancy within 3 years prior to starting study treatment (excluding early gastric cancer, thyroid cancer, cervical cancer or skin cancer) * Severe renal impairment * Severe hepatic impairment * Current active infection * Known KRAS-mutation for Part A and Part C, Known KRAS-mutation for Part B or BRAF matant * Medical or psychiatric illness that, in the opinion of the investigator, may affect compliance with scheduled visits * Pregnant (potentially fertile patients) or lactating women * Patients refuse to use acceptable forms of contraceptions from the time of consent through six months after the study drug administration
References
Publications (1)
- DERIVEDOh DY, Lee KW, Han SW, Kim JW, Shin JW, Jo SJ, Won J, Hahn S, Lee H, Kim WH, Bang YJ. A First-in-Human Phase I Study of GC1118, a Novel Anti-Epidermal Growth Factor Receptor Antibody, in Patients with Advanced Solid Tumors. Oncologist. 2019 Aug;24(8):1037-e636. doi: 10.1634/theoncologist.2019-0294. Epub 2019 Jun 4. PMID 31164456