Description:
To evaluate the safety of GEN1042 in patients with malignant solid tumors
To evaluate the safety of GEN1042 in patients with malignant solid tumors
Recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| GEN1042 | Treatment Administered |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Treatment Administered | Experimental | GEN1042 will be administered every 21 days |
|
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 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, or
progressive brain metastases or stroke.
Prior therapy:
- Radiotherapy within 14 days prior to first GEN1042 administration
- 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.
- History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
- Toxicities from previous anti-cancer therapies that have not resolved
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Dose Limiting Toxicity (DLT) |
| Time Frame: | First Cycle (21 days) |
| Safety Issue: | |
| Description: | Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Genmab |
August 16, 2021