Clinical Trials/NCT06771921

NCT06771921

Terminated

Phase 1

First-in-Human, Open-Label, Dose-Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of GEN1078 in Subjects With Malignant Solid Tumors

Genmab6 sites in 2 countries3 target enrollmentJanuary 29, 2025

ConditionsMalignant Solid Tumor

InterventionsGEN1078

DrugsGEN1078

Overview

Phase: Phase 1
Intervention: GEN1078
Conditions: Malignant Solid Tumor
Sponsor: Genmab
Enrollment: 3
Locations: 6
Primary Endpoint: Dose Escalation: Number of Participants With Dose-limiting Toxicities (DLTs)
Status: Terminated
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to measure the following in participants with solid cancers who receive GEN1078.

The side effects seen with GEN1078
What the body does with GEN1078 once it is administered
What GEN1078 does to the body once it is administered
How well GEN1078 works against advanced solid tumors

Trial details include:

The estimated trial duration is 8 months for an individual participant (the trial duration may vary for each participant).
The treatment duration will be an estimated 3-month treatment period (the duration of treatment may vary for each participant).
The visit frequency will be daily or visits every few days for the first few months.

All participants will receive active drug; no one will be given placebo.

Registry

clinicaltrials.gov

Start Date

January 29, 2025

End Date

June 11, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Genmab

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have at least 1 measurable lesion per RECIST v1.1 assessed by the investigator.
•Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to
•Dose Escalation Only
•Participant must have histologically or cytologically confirmed solid tumor(s) for which there is no further available standard therapy likely to confer clinical benefit (or participant is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1078 may be beneficial.
•Must have either recurrence after, or progression on available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting.
•Expansion Only
•Participant must have advanced (unresectable) or metastatic, histologically confirmed diagnosis of selected solid cancers.

Exclusion Criteria

•Has significant cardiovascular impairment within 6 months prior to the first dose of trial drug, including presence of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] class III and IV), or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
•Known unstable central nervous system (CNS) metastases or any active or history of carcinomatous meningitis.
•Has been exposed to any of the following prior therapies within the specified timeframes:
•Prior therapy with a compound targeting the same targets as GEN1078 or any cell-based therapies.
•Radiotherapy within 14 days prior to C1D
•Palliative radiotherapy of bone metastases up to 7 days prior to C1D1 will be allowed.
•Treatment with any investigational or non-investigational anticancer agent (including investigational vaccines) or used an invasive investigational medical device within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the first dose of GEN
•Chemotherapy within 2 weeks prior to the first dose of GEN
•Prophylaxis with live, attenuated vaccines within 28 days prior to first dose of GEN1078; or prophylaxis with the first and/or subsequent injection(s) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid vaccine within 14 days prior to first dose of GEN
•Chronic systemic immunosuppressive treatment, including corticosteroids, ie, prednisone \&gt;10 milligrams (mg) daily (or equivalent) or a cumulative dose \&gt;140 mg prednisone within 14 days (or equivalent) before the first dose of GEN

Arms & Interventions

Dose-Escalation

GEN1078 will be administered as monotherapy until one of the treatment discontinuation criteria has been met.

Intervention: GEN1078

Dose Expansion

GEN1078 will be administered as monotherapy until one of the treatment discontinuation criteria has been met.

Intervention: GEN1078

Outcomes

Primary Outcomes

Dose Escalation: Number of Participants With Dose-limiting Toxicities (DLTs)

Time Frame: Up to 21 days

Toxicities will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0, except for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) which will be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

Dose Escalation: Number of Participants With Adverse Events (AEs)

Time Frame: From first dose until the end of the safety follow-up period (30 days after the last dose)

Dose Expansion: Confirmed Objective Response Rate (ORR)

Time Frame: Up to approximately 5 years

Confirmed ORR is defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by the investigator.

Secondary Outcomes

Dose-Escalation and Expansion: Clearance (CL) of GEN1078(Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Volume of Distribution (Vd) of GEN1078(Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-last) of GEN1078(Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of GEN1078(Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) of GEN1078(Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Time to Reach Cmax (Tmax) for GEN1078(Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Predose Concentration for GEN1078(Predose up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Terminal Half-life (t½) of GEN1078(Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months))
Dose-Escalation and Expansion: Number of Participants with Anti-drug Antibodies (ADAs)(Up to approximately 5 years)
Dose Escalation: Confirmed ORR(Up to approximately 5 years)
Dose-Escalation and Expansion: Duration of Response (DOR)(Up to approximately 5 years)
Dose-Escalation and Expansion: Disease Control Rate (DCR)(Up to approximately 5 years)
Dose-Escalation and Expansion: Time to Response (TTR)(Up to approximately 5 years)
Dose Expansion: Number of Participants With AEs(From first dose until the end of the safety follow-up period (30 or 60 days after the last dose))