GEN1042 Safety Trial in Subjects With Malignant Solid Tumors

Colorectal Cancer Clinical Trial

Official title:

A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects With Malignant Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03937024
• Other study ID #: GCT1042-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2019
• Est. completion date: July 2022

Study information

• Verified date: May 2019
• Source: Genmab
• Contact: Genmab A/S Trial Information
• Phone: +4570202728
• Email: clinicaltrials[@]genmab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety of GEN1042 in patients with malignant solid tumors

Description:

The trial is an open-label, multi-center, safety trial of GEN1042. The trial consists of two parts, a dose escalation (phase 1, first-in-human (FIH) and an expansion part (Phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: July 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Dose Escalation:

• Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.

Expansion:

• Histologically or cytologically confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standard therapy

Dose Escalation and Expansion:

• Measurable disease according to RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) 0-1

• Acceptable bone marrow and hematological, liver and renal functions

• Acceptable coagulation status

Exclusion Criteria:

Uncontrolled intercurrent illness, including but not limited to:

• Ongoing or active infection treated with intravenous anti-infective therapy less than 2 weeks prior to first dose

• Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.

• Uncontrolled hypertension despite optimal medical management.

• Evidence of significant autoimmune disease suggesting risk for immune-related adverse events (irAEs).

• History of irAEs that led to treatment discontinuation of prior ICP inhibitor

• History of myositis, Guillain-Barré syndrome, or myasthenia gravis (any grade)

• History of chronic liver disease or evidence of hepatic cirrhosis.

• History of non-infectious pneumonitis that required steroids or currently has pneumonitis.

• History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042.

• Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.

• Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (< 6 months) or progressive brain metastases or stroke.

Prior therapy:

• Radiotherapy within 14 days prior to first GEN1042 administration

• Treatment with an anti-cancer agent (within 28 days or after at least 4 half-lives of the drug, whichever is shorter), prior to GEN1042 administration.

• History of = grade 3 allergic reactions to monoclonal antibody (mAb) therapy

• Toxicities from previous anti-cancer therapies that have not resolved

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Colorectal Neoplasms
• Malignant Solid Tumor
• Melanoma
• Neoplasms
• Non Small Cell Lung Cancer

Intervention

Biological:
• GEN1042
GEN1042 will be administered intravenously every 21 days. The dose level will be determined by the starting dose and escalation steps in the trial

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genmab	Biontech AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)	Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)	First Cycle (21 days)
Primary	Adverse Events (AEs)	Incidence of adverse events as assessed by CTCAE v5.0	Throughout study until the end of the safety follow-up period (2 months after last dose)