Malignant solid tumors: Patients with advanced and/or metastatic colorectal cancer (CRC), non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), gastric (incl. esophagogastric junction) cancer, pancreatic cancer or urothelial cancer. MedDRA version: 21.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 100000004864
Conditions
Interventions
Product Code: GEN1029
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not issued
CAS Number: 2109730-69-8
Current Sponsor code: 1029-01
Other descriptive name: Hexabody
Sponsors
Genmab B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Dose Escalation Part: Patients with advanced and/or metastatic CRC, NSCLC, TNBC, RCC, gastric (incl. esophagogastric junction), pancreas or urothelial cancer who have no available standard therapy likely to confer clinical benefit or who are not candidates for such available therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1029 may be beneficial. For Dose Expansion Part: Patients with advanced and/or metastatic cancer in up to seven of the following indications: CRC, NSCLC, TNBC, RCC, gastric, pancreas or urothelial cancer who have failed specific anticancer therapies for metastatic disease. - Patient must be = 18 years of age - Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 - Have an acceptable hematological status - Have an acceptable renal function - Have an acceptable liver function - Have an Eastern Cooperative Oncology Group performance status of 0 or 1 - Body weight = 40kg - Patients, both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after the last infusion of IMP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 390 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: - Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first IMP administration - Have clinically significant cardiac disease - Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg, despite optimal medical management - Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke - Have received a cumulative dose of corticosteroid = 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first IMP administration - History of = grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial - Radiotherapy within 14 days prior to first IMP administration - Any prior therapy with a compound targeting DR4 or DR5 - History of chronic liver disease or evidence of hepatic cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dose Escalation Part: - Determine the MTD and/or the recommended Phase 2 dose (RP2D) - Establish the safety profile of GEN1029 Dose Expansion Part: - To evaluate the Objective Response Rate (ORR) by indication;Secondary Objective: Dose Escalation Part: - Establish the PK profile and evaluate immunogenicity of GEN1029 after single and multiple infusions - Evaluate the anti-tumor activity of GEN1029 Dose Expansion Part: - Evaluate the anti-tumor activity of GEN1029 - To further describe the safety profile of GEN1029 - Evaluate the pharmacokinetic (PK) profile as feasible, evaluate immunogenicity of GEN1029 after single and multiple infusions;Primary end point(s): Dose Escalation Part: - Dose limiting Toxicities (DLTs) - Adverse events (AEs) and safety laboratory parameters (hematology and biochemistry) Dose Expansion Part: - Objective Response Rate (ORR) by indication;Timepoint(s) of evaluation of this end point: DLTs: dose limiting toxicities will be collected for the first two cycles i.e. DLT period of 28 days. AEs: screening; Day 1, 2, 3, 8 during Cycles 1-3; Days 1, 8 during subsequent Cycles (4-PD); EoT; 4, 13, 26, 39, 52 Weeks after last dosing. ORR: during the entire study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Dose Escalation Part: - PK parameters of GEN1029 - Immunogenicity of GEN1029 - Anti-tumor activity measured by tumor shrinkage - Objective Response, Progression-Free Survival (PFS), Overall Survival (OS), Duration of Response (DoR), and Time to Response (TTR) Dose Expansion Part: - Anti-tumor activity measured by tumor shrinkage - Objective Response, Progression-Free Survival (PFS), Overall Survival (OS), Duration of Response (DoR), and Time to Response (TTR) - Adverse events (AEs) and safety laboratory parameters - PK parameters - Immunogenicity of GEN1029;Timepoint(s) of evaluation of this end point: During the entire study | — |
Countries
France, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Genmab B.V.
Outcome results
None listed