GEN1046 Safety Trial in Patients With Malignant Solid Tumors
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03917381 |
|
Recruitment Status :
Recruiting
First Posted : April 17, 2019
Last Update Posted : June 2, 2021
|
Sponsor:
Genmab
Collaborator:
BioNTech SE
Information provided by (Responsible Party):
Genmab
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of the trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumors Non-small Cell Lung Cancer Urothelial Carcinoma Endometrial Carcinoma Triple Negative Breast Cancer Squamous Cell Carcinoma of the Head and Neck Cervical Cancer | Biological: GEN1046 Biological: GEN1046 in combination with docetaxel (in a single expansion cohort) | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 512 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | The starting dose is administered as a flat dose. Dose escalation steps are based on safety data |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors |
| Actual Study Start Date : | May 14, 2019 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
Drug Information available for:
Docetaxel
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm
GEN1046 Open label, single arm trial where GEN1046 will be administered (in one expansion cohort in combination with docetaxel)
|
Biological: GEN1046
GEN1046 will be administered intravenously once every 21 days. Biological: GEN1046 in combination with docetaxel (in a single expansion cohort) GEN1046 and docetaxel will be administered intravenously once every 21 days. |
Primary Outcome Measures :
- Dose limiting toxicity (DLT) [ Time Frame: DLTs are assessed during the first cycle (21 days) in each cohort] ]to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
- Adverse events [ Time Frame: AEs are collected throughout the study and up to 2 months after last subject last treatment ]Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
- Safety laboratory parameters (hematology, biochemistry, coagulation, endocrines) [ Time Frame: Safety laboratory data are collected throughout the study and up to 2 months after last subject last treatment ]Laboratory parameters graded by CTCAE v5.0
Information from the National Library of Medicine
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917381
Contacts
| Contact: Genmab Trial Information | +4570202728 | clinicaltrials@genmab.com |
Locations
Show 37 study locations
Sponsors and Collaborators
Genmab
BioNTech SE
| Responsible Party: | Genmab |
| ClinicalTrials.gov Identifier: | NCT03917381 |
| Other Study ID Numbers: |
GCT1046-01 |
| First Posted: | April 17, 2019 Key Record Dates |
| Last Update Posted: | June 2, 2021 |
| Last Verified: | June 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
|
Carcinoma Triple Negative Breast Neoplasms Squamous Cell Carcinoma of Head and Neck Endometrial Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Carcinoma, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Uterine Diseases Breast Neoplasms Breast Diseases Skin Diseases Head and Neck Neoplasms Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |