Suspended

GEN1286 for Advanced Solid Tumors

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What is being tested

GEN1286

Drug
Who is being recruted

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorGenmab
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 13, 2024

Actual date on which the first participant was enrolled.

This clinical trial is designed to study a new medication called GEN1286 for people with advanced solid tumors. Solid tumors are abnormal masses of tissue that usually don't contain cysts or liquid areas, and they can occur in various parts of the body, like the breast, lung, or liver. The study aims to determine if GEN1286 is safe and tolerable for patients, how the body processes the drug, and its potential to fight tumors. Additionally, researchers will observe if the drug causes any immune response. This study is important because finding effective treatments for advanced tumors can improve outcomes and provide new options for patients. Participants in the study will receive GEN1286 in two main phases. In the first part, the dose of GEN1286 will be gradually increased to identify the safest and most effective amount. Once an optimal dose is found, the second part will focus on specific types of tumors to further explore the drug's effects. Participants will be closely monitored to see how their bodies react to the treatment, and any changes in their tumors will be documented. The study seeks to understand the drug's properties thoroughly, including any potential risks or unexpected reactions.

Official TitleA Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
NCT06685068
Principal SponsorGenmab
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
Participants must be ≥ 18 years of age at the time of informed consent

Participants must have measurable disease according to RECIST 1.1

Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1

Participants must have adequate organ, bone marrow, liver, coagulation, and renal function

Show More Criteria

1 exclusion criteria prevent from participating
Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
Suspended

START Midwest

Grand Rapids, United States
Suspended

START San Antonio

San Antonio, United States
Suspended

START Mountain Region

West Valley City, United States
Suspended4 Study Centers