GEN1042 safety trial in patients with malignant solid tumors

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 147

Inclusion Criteria

For Both Dose Escalation and Expansion
• Subject must have measurable disease according to RECIST 1.1.
• Subject must have Eastern Cooperative Oncology Group (ECOG) 0-1.
• Subject must have adequate organ and bone marrow function as defined in protocol.
For Dose Escalation:
• Subjects must 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:
• Subjects must have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, CRC cancer for whom there are no alternative
treatment options.
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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

•Subject has uncontrolled intercurrent illness, including but not limited
to:
• Ongoing or active infection requiring intravenous treatment with antiinfective therapy that has been administered less than 2 weeks prior
to first dose
• 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.
• Subjects with a history of grade 3 or higher irAEs that led to
treatment discontinuation of a checkpoint inhibitor should be excluded.
Subjects with irAEs below grade 3 that led to discontinuation should be
discussed with the sponsor.
• History of liver disease (e.g., alcoholic hepatitis or non-alcoholic steatohepatitis (NASH), drug-related or auto-immune hepatitis.
• 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 GEN1042.
• Serious, non-healing wound, skin ulcer (of any grade), or bone
fracture.
• Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
• Prior therapy:
• Radiotherapy: Radiotherapy within 14 days prior to first GEN1042
administration. Palliative radiotherapy will be allowed.
• Unless otherwise noted, treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration. The use of RANK-L inhibitors and bisphosphonates (if on a stable dose for at least 4 weeks) is permitted while participating in this trial. However, the initiation of growth factors and bisphosphonates is not allowed during the first 4 weeks of GEN1042 treatment, unless agreed upon by the investigator and medical monitor.
• Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to grade 1 or less with the exception of alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia,
hyperthyroidism, hypothyroidism, and
peripheral neuropathy must have recovered to = grade 2.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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