- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03937024
Recruitment Status Not yet recruiting
First Posted May 3, 2019
Last update posted May 3, 2019
To evaluate the safety of GEN1042 in patients with malignant solid tumors
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.
|Experimental: Treatment Administered
GEN1042 will be administered every 21 days
GEN1042 will be administered intravenously every 21 days. The dose level will be determined by the starting dose and escalation steps in the trial
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
• Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or
unresectable and for whom there is no available standard therapy.
• Histologically or cytologically confirmed diagnosis of relapsed or refractory, advanced
and/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standard
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
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
- 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
- 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
- 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
Contact: Genmab A/S Trial Information +4570202728 email@example.com