GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Brief Title

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Official Title

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors

Brief Summary

      The purpose of the trial is to evaluate the safety of GEN1046 as monotherapy and in
      combination therapies in patients with malignant solid tumors

Detailed Description

      The trial is an open-label, multi-center safety trial of GEN1046. The trial consists of two
      parts, a dose escalation part (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.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Dose limiting toxicity (DLT)

Secondary Outcome

 PK parameters

Condition

Solid Tumors

Intervention

GEN1046

Study Arms / Comparison Groups

 Dose escalation

Description:  GEN1046 Open label, single arm trial where GEN1046 will be administered as monotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

May 14, 2019

Completion Date

December 2024

Primary Completion Date

June 2024

Eligibility Criteria

        Key Inclusion Criteria:

        For Dose Escalation:

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

        For Expansion:

        • Have histologically or cytological confirmed diagnosis of relapsed or refractory,
        advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not
        anymore candidates for standard therapy For separate expansion cohorts: metastatic NSCLC
        without prior systemic treatment regimens for metastatic disease.

        For Both Dose Escalation and Expansion

          -  Have measurable disease according to RECIST 1.1

          -  Have Eastern Cooperative Oncology Group (ECOG) 0-1

          -  Have an acceptable hematological status

          -  Have acceptable liver function

          -  Have an acceptable coagulation status

          -  Have acceptable renal function

        Key Exclusion Criteria:

          -  Have uncontrolled intercurrent illness, including but not limited to:

               -  Ongoing or active infection requiring intravenous treatment with antiinfective
                  therapy

               -  Symptomatic congestive heart failure (Grade III or IV as classified by the New
                  York Heart Association), unstable angina pectoris or cardiac arrhythmia

               -  Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or
                  diastolic blood pressure ≥ 100 mmHg, despite optimal medical management

               -  Ongoing or recent evidence of autoimmune disease

               -  History of irAEs that led to prior checkpoint treatment discontinuation

               -  Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any
                  grade

               -  History of chronic liver disease or evidence of hepatic cirrhosis

               -  History of non-infectious pneumonitis that has 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 GEN1046

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

          -  Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new
             (younger than 6 months) or progressive brain metastases or stroke

          -  Prior therapy:

               -  Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration.
                  Palliative radiotherapy will be allowed.

               -  Treatment with an anti-cancer agent (within 28 days or after at least 5
                  half-lives of the drug, whichever is shorter), prior to GEN1046 administration.
                  Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid,
                  etc.) and denosumab

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

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +4570202728, [email protected]

Location Countries

Czechia

Location Countries

Czechia

Administrative Informations

NCT ID

NCT03917381

Organization ID

GCT1046-01

Secondary IDs

2018-003402-63

Responsible Party

Sponsor

Study Sponsor

Genmab

Collaborators

 BioNTech SE

Study Sponsor

, ,

Verification Date

December 2022