First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumors

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; 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: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864

• Registration Number: EUCTR2017-001394-16-GB
• Lead Sponsor: Genmab B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-02
• Study Completion: 2021-10-12
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified