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Malignant Solid TumorPhase 1/2NCT06771921

A First-in-Human Trial of Safety and Efficacy of GEN1078 in Participants With Solid Tumors

A Phase 1/2 study testing GEN1078 in people with Malignant Solid Tumor, run by Genmab at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Tumor
What is being tested?
GEN1078
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
6 sitesin 2 countries
Study dates
29 Jan 2025to 11 Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 1.
  • 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.

Who cannot join

  • 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 C1D1. 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 GEN1078.
Show all 13Show fewer
  • Chemotherapy within 2 weeks prior to the first dose of GEN1078.
  • 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 GEN1078.
  • Chronic systemic immunosuppressive treatment, including corticosteroids, ie, prednisone \>10 milligrams (mg) daily (or equivalent) or a cumulative dose \>140 mg prednisone within 14 days (or equivalent) before the first dose of GEN1078. Replacement therapy (eg, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.
  • Has received granulocyte colony-stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within 2 weeks prior to the first dose GEN1078 or being chronically transfusion dependent.
  • Has received other T-cell activating surface marker. Note: Prior treatment with anti-T-cell Ig and ITIM domain (aTIGIT), anti-programmed cell death protein 1 (aPD1), anti-programmed death-ligand 1 (aPDL1), anti-lymphocyte activation gene 3 protein (aLAG3), anti-cytotoxic T-lymphocyte-associated protein 4 (aCTLA-4) is allowed.
  • The initiation of growth factors and bisphosphonates is not allowed during the first 4 weeks of GEN1078 administration, unless agreed upon by the investigator and sponsor medical monitor. However, the use of receptor activator of nuclear factor kappa-Β ligand (RANK-L) inhibitors and bisphosphonates (if on stable dose for at least 4 weeks) is permitted while participating in this trial.
  • NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Centro Integral Oncologico Clara Campal

    Madrid

  • Hospital Universitary Fundacion Jimenez Diaz

    Madrid

  • NEXT Oncology Madrid

    Madrid

  • Clinica Universidad de Navarra

    Pamplona

Other trials in Spain

Denmark1 site

  • Righshospitalet (Copenhagen University Hospital)

    Copenhagen

Other trials in Denmark

About this study

Official title: 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

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
Read more

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.

Being tested
GEN1078

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEN1078Drug

    Specified dose on specified days.

Study groups in NCT06771921
Study groupRoleWhat they receive
Dose-EscalationExperimentalGEN1078 will be administered as monotherapy until one of the treatment discontinuation criteria has been met.
Receives: Drug: GEN1078
Dose ExpansionExperimentalGEN1078 will be administered as monotherapy until one of the treatment discontinuation criteria has been met.
Receives: Drug: GEN1078

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to 21 days

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

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

  3. Dose Expansion: Confirmed Objective Response Rate (ORR)

    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.

    Measured: Up to approximately 5 years

Secondary outcomes (14)

  1. Dose-Escalation and Expansion: Clearance (CL) of GEN1078

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months)

  2. Dose-Escalation and Expansion: Volume of Distribution (Vd) of GEN1078

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months)

  3. Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-last) of GEN1078

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months)

  4. Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of GEN1078

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months)

  5. Dose-Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) of GEN1078

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months)

  6. Dose-Escalation and Expansion: Time to Reach Cmax (Tmax) for GEN1078

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months)

  7. Dose-Escalation and Expansion: Predose Concentration for GEN1078

    Measured: Predose up to end of treatment (approximately 3 months)

  8. Dose-Escalation and Expansion: Terminal Half-life (t½) of GEN1078

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 months)

  9. Dose-Escalation and Expansion: Number of Participants with Anti-drug Antibodies (ADAs)

    Measured: Up to approximately 5 years

  10. Dose Escalation: Confirmed ORR

    Confirmed ORR is defined as the percentage of participants with confirmed BOR of CR or PR based on RECIST v1.1 as assessed by the investigator.

    Measured: Up to approximately 5 years

  11. Dose-Escalation and Expansion: Duration of Response (DOR)

    DOR is defined as the time from first documentation of response (CR or PR) to the date of the first documented progression or death whichever occurs earlier based on RECIST v1.1 as assessed by the investigator.

    Measured: Up to approximately 5 years

  12. Dose-Escalation and Expansion: Disease Control Rate (DCR)

    The DCR is defined as the percentage of participants with confirmed BOR of CR, PR, or Stable Disease (SD) according to RECIST v1.1 as assessed by investigator.

    Measured: Up to approximately 5 years

  13. Dose-Escalation and Expansion: Time to Response (TTR)

    TTR based on investigator assessment is defined as the time from Cycle 1, Day 1 (C1D1) to first documentation of objective response (CR or PR) in participants achieving PR or CR according to RECIST v1.1 as assessed by investigator.

    Measured: Up to approximately 5 years

  14. Dose Expansion: Number of Participants With AEs

    Measured: From first dose until the end of the safety follow-up period (30 or 60 days after the last dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start29 Jan 2025
  3. Primary completion11 Jun 2025
  4. Study completion11 Jun 2025

Why it stopped: The sponsor has made the decision to terminate further development of GEN1078 based on emerging safety observations and overall benefit-risk assessment of 1078

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
No randomization will be performed in the Dose-escalation part. In Dose-expansion part, if two expansion doses are identified, participants will be randomized to either Expansion Dose 1 or Expansion Dose 2.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771921
Sponsor's protocol ID
GCT1078-01
Other IDs
2024-515752-21-00
Status last verified
Jan 2026
First submitted
8 Jan 2025
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GEN1078 in people with Malignant Solid Tumor, run by Genmab at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The sponsor has made the decision to terminate further development of GEN1078 based on emerging safety observations and overall benefit-risk assessment of 1078). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: Up to 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06771921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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