Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.

Official Title

A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

Details

This is an open-label, multicenter phase 1/2 study designed to assess the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of GEN1042 administered as a monotherapy or in combination in subjects with metastatic or locally advanced solid tumors.

Keywords

Malignant Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC), Neoplasms, Squamous Cell Carcinoma of Head and Neck, Gemcitabine, Paclitaxel, Albumin-Bound Paclitaxel, Cisplatin, Carboplatin, Pembrolizumab, Pemetrexed, GEN1042, Nab paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

Monotherapy - Dose Escalation and Dose Expansion Parts

  • Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
  • Subjects with a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy

Combination Therapy - Dose Expansion Part

  • Subjects with unresectable Stage III or Stage IV melanoma with no prior systemic anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal melanoma is excluded.
  • Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation.
  • Subjects with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting and tumor demonstrating PD-L1 IHC CPS ≥1.
  • Subjects with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

General (all phases):

  • Must be age ≥ 18 years of age
  • Measurable disease according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Normal or adequate liver, renal, cardiac and bone marrow function

You CAN'T join if...

Monotherapy - Dose Escalation and Dose Expansion Parts

  • 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
  • Radiotherapy within 14 days prior to first GEN1042 administration
  • Toxicities from previous anti-cancer therapies that have not resolved

Combination Therapy - Dose Expansion Part

  • Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of the first dose of trial treatment.
  • Radiotherapy within 14 days of start of trial treatment or received lung radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.

General (all phases)

  • Subject has an active, known, or suspected autoimmune disease.
  • History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
  • History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
  • Subject with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • Moores Cancer Center at the UC San Diego Health not yet accepting patients
    San Diego California 92037 United States
  • Washington University School of Medicine accepting new patients
    Saint Louis Missouri 63110 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Genmab
ID
NCT04083599
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 647 study participants
Last Updated