Assessing the safety and effectiveness of GEN1057 for treating advanced cancer

A First-In-Human, Open-Label, Dose Escalation Trial to Evaluate the Safety and Antitumor Activity of GEN1057 in Subjects With Malignant Solid Tumors

This study is testing a new antibody called GEN1057 to see if it can safely help people with advanced cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Genmab (industry)
• Locations: 5 sites (Nashville, Tennessee and 4 other locations)
• Trial ID: NCT06573294 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and antitumor activity of the antibody GEN1057 as a single agent in patients with advanced or metastatic malignant solid tumors. It is a first-in-human, open-label, multicenter, and multinational study that will assess different dose levels to determine the optimal dose for further investigation. Participants will receive the active drug without a placebo, and the study will monitor safety, tolerability, pharmacokinetics, and immunogenicity over a treatment duration of up to four months, followed by a six-month follow-up period.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic malignant solid tumors who have not responded to standard therapies and have a life expectancy of at least three months.

Not a fit: Patients who have recently received investigational anticancer agents or have other treatment options available may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that have limited treatment alternatives.

How similar studies have performed: Other studies involving monoclonal antibodies for similar cancer types have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Key Inclusion Criteria:

* Advanced and/or metastatic malignant solid tumors, who have progressed on standard of care therapy for whom there is no available standard therapy likely to provide clinical benefit, or who are not candidates for available therapy, and for whom experimental therapy with GEN1057 may be beneficial, in the opinion of the investigator.
* Be at least 18 (or the legal age of consent in the jurisdiction in which the trial is taking place) years of age.
* Have measurable disease according to RECIST v1.1.
* Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at screening and on C1D1 pretreatment. Note: If screening ECOG PS is assessed within 3 days prior to C1D1, ECOG PS does not need to be reassessed at C1D1.
* Have a life expectancy of ≥3 months.

Key Exclusion Criteria:

* Has been exposed to any of the following prior therapies/treatments within the specified timeframes:

  * Treatment with an investigational anticancer agent within 28 days or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.
  * Treatment with an investigational drug, including investigational vaccines within 28 days before the planned first dose of trial treatment.
  * Prior treatment with live, attenuated vaccines within 28 days prior to initiation of GEN1057. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live, attenuated vaccines and are not allowed. Experimental and/or nonauthorized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations are not allowed.
  * Used an invasive investigational medical device within 28 days before the planned first dose of trial treatment.
* Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ grade 2. There is no limitation for alopecia and hearing impairment from previous therapies.
* Has known, symptomatic brain metastases. Asymptomatic brain metastases are allowed provided that they have been treated, have been stable for \>28 days as documented by radiographic imaging, and do not require prolonged (\>14 days) systemic corticosteroid therapy.
* Has a past or current malignancy other than inclusion diagnosis.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Where this trial is running

Nashville, Tennessee and 4 other locations

• SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
• South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States (RECRUITING)
• National Cancer Center, Tsukiji 5-1-1 — Tokyo, Japan (RECRUITING)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (RECRUITING)
• Start Madrid Centro Integral Oncologico Clara Campal CIOCC — Madrid, Spain (RECRUITING)

Study contacts

• Study coordinator: Genmab Trial Information

Conditions: Advanced Malignant Solid Tumor, Metastatic Malignant Solid Tumor