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

INTRODUCTION

  • Org Study ID: GCT1046-01
  • Secondary ID: N/A
  • NCT ID: NCT03917381
  • Sponsor: Genmab

BRIEF SUMMARY

The purpose of the trial is to evaluate the safety of acasunlimab (also known as 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 acasunlimab (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.

  • Overall Status
    Recruiting
  • Start Date
    May 14, 2019
  • Phase
    P, P
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose limiting toxicity (DLT)

Primary Outcome 1 - Timeframe: DLTs are assessed during the first cycle (21 days) in each cohort]

Primary Outcome 2 - Measure: Adverse events

Primary Outcome 2 - Timeframe: throughout the study and until end of safety follow-up period (60 days after last dose)

Primary Outcome 3 - Measure: Safety laboratory parameters (hematology, biochemistry, coagulation, endocrines)

Primary Outcome 3 - Timeframe: throughout the study and until end of safety follow-up period (60 days after last dose)

Primary Outcome 4 - Measure: For expansion cohort 1 only: Objective Response Rate (ORR)

Primary Outcome 4 - Timeframe: throughout the study until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months)

CONDITION

  • S
  • N
  • U
  • E
  • T
  • S
  • C

ELIGIBILITY

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 acasunlimab

- * 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 acasunlimab 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 acasunlimab 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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: S

Role: S

Affiliation: G

Overall Contact

Name: S

Phone: +

Email: c

LOCATION

Facility Status Contact
Facility: Mayo Clinic
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office
855-776-0015

Contact
Cassandra Moore, Dr.

Facility: Yale University Cancer Center
New Haven, Connecticut 06520-8028
United States
Status: Recruiting Contact: Contact
Patricia M LoRusso

Facility: Mayo Clinic
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office
855-776-0015

Contact
Yanyan Lou, Dr.

Facility: Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Suresh Ramalingam

Facility: University of Iowa Hospitals
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Muhammed Furqan

Facility: Norton Healthcare Inc
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
John Hamm

Facility: University of Michigan
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact
Erin Cobain

Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: Contact
Manish Sharma

Facility: Mayo Clinic
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office
855-776-0015

Contact
Ashish Chintakuntlawar, Dr.

Facility: Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Jeffrey Ward

Facility: NYU Langone
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Daniel Cho

Facility: UNC Chapel Hill
Chapel Hill, North Carolina 27514
United States
Status: Recruiting Contact: Contact
Jared Weiss

Facility: Levine Cancer Institute, Atrium Health
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: Contact
Daniel Haggstrom

Facility: University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Alberto Montero