Non-CNS TumorPhase 1/2NCT05491317
A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors
A Phase 1/2 study testing GEN1042, Pembrolizumab and Radiotherapy in people with Non-CNS Tumor, run by Genmab at 2 sites in France.
Trial summary
The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-CNS Tumor
- What is being tested?
- GEN1042, Pembrolizumab and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Mar 2023to 11 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy.
- At least 18 years of age.
- Signed informed consent prior to any screening procedures.
- Measurable disease according to RECIST v1.1.
- Life expectancy of >3 months.
- Qualify for palliative radiotherapy as an available option for disease management.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Normal or adequate liver, renal, cardiac and bone marrow function.
Who cannot join
- Prior malignancy except for non-melanoma skin cancers and in situ cancers.
- Condition contraindicating radiotherapy.
- Rapidly progressing disease.
- Active, known or suspected autoimmune disease.
- History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
- Contraindications to the use of pembrolizumab.
Show all 10Show fewer
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment.
- Received an allogeneic tissue/solid organ transplant.
- Active infection requiring systemic therapy.
- Note: Other protocol defined inclusion and exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Leon Berard
Lyon, 69008
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors
The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.
Read the detailed description
The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization).
Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2.
Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1.
Participants in both parts are treated with one of the following combinations:
- Radiotherapy + GEN1042
- Radiotherapy + GEN1042 + Pembrolizumab
While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.
- Conditions
- Non-CNS Tumor
- Being tested
- GEN1042, Pembrolizumab, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN1042Biological
Intravenous
PembrolizumabDrug
Intravenous
RadiotherapyRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + GEN1042 | Experimental | Not described Receives: Biological: GEN1042; Radiation: Radiotherapy |
| Radiotherapy + GEN1042 + Pembrolizumab | Experimental | Not described Receives: Biological: GEN1042; Drug: Pembrolizumab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as any grade 5 toxicity, treatment-related toxicity that caused the participant to discontinue treatment during Cycle 1, febrile neutropenia grade 3 or grade 4, grade 3 thrombocytopenia associated with clinically significant bleeding, grade 4 thrombocytopenia of any duration, grade 4 anemia, any grade ≥3 non-hematologic clinical (non-laboratory) toxicity with exceptions per protocol, any grade 3 or grade 4 non-hematologic laboratory value if clinically significant medical intervention was required to treat the participant or the abnormality led to hospitalization, or the abnormality persisted for >7 days, and the abnormality resulted in a drug-induced liver injury (DILI) as defined by Hy's Law. Toxicities were graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
Measured: 21 days
Secondary outcomes (9)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) v1.1 as assessed by investigator. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lesions. PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to approximately 2 years 5 months
Duration of Response (DOR)
DOR was defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator.
Measured: Up to approximately 2 years 5 months
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with BOR of CR, PR, and stable disease (SD) according to RECIST v1.1 as assessed by investigator. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lesions. PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Measured: Up to approximately 2 years 5 months
Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by investigator.
Measured: Up to approximately 2 years 5 months
Overall Survival (OS)
OS was defined as the time from date of randomization (or date of first administration of GEN1042 ± pembrolizumab treatment for participants in Part 1) to date of death due to any cause.
Measured: Up to approximately 2 years 5 months
Number of Participants With Abscopal Response in Non-irradiated Target Lesions As Assessed by the Investigator
An abscopal response described radiotherapy (RT)-induced immune-mediated tumor regression at sites distant to the irradiated field. For the purpose of this trial, an abscopal response was defined as a reduction of at least 30% in diameter of the best responding unirradiated target lesion. Data are reported for the number of participants with abscopal response in non-irradiated target lesions as assessed by the investigator.
Measured: Up to approximately 2 years 5 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE was any AE that occurred or worsened after the first dose of trial treatment. A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Up to approximately 2 years 5 months
Blood Concentration of GEN1042 Over Time
Blood samples were collected for measurement of serum concentrations of GEN1042. Data are reported for Cycle (C)1 Day (D)1 pre-dose and end of infusion (EOI), C1D8, C1D15, C2D1 pre-dose and end of infusion, C2D8, C2D15, C3D1 pre-dose and end of infusion,C4D1 pre-dose and end of infusion,C4D8, C5D1 pre-dose and end of infusion, C7D1 pre-dose and end of infusion,C11D1 end of infusion,C12D1 end of infusion+2 hours,C15D1 end of infusion,C19D1 end of infusion,C23D1 end of infusion, End of Treatment (~D487) and Safety Follow Up (~D517). Cycles were 21 days in length.
Measured: At multiple timepoints (as described in the "Outcome Measure Description" field between Cycle 1 Day 1 up to Safety Follow Up [up to approximately Day 517]). Cycles were 21 days in length.
Number of Participants With Anti-drug Antibodies (ADAs)
Venous blood samples were drawn for analysis of ADAs. Data are reported for the number of participants with an on-treatment ADA status of positive. For on-treatment results, a participant was considered ADA positive if either 1) ADA was negative at baseline and at least one on-treatment result was positive 2) positive at baseline and at least one positive on-treatment result with at least one titer higher than baseline.
Measured: Up to approximately 2 years 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start8 Mar 2023
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Why it stopped: After reviewing all available data from Part 1 of the trial, the Sponsor has decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-CNS TumorStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 is sequential, Part 2 is parallel (randomized)
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491317
- Sponsor's protocol ID
- GCT1042-02
- Other IDs
- 2022-000509-29, 2023-508529-29-00, RECF-005058, 2023
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2022
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05491317
- Acronym / sponsor ID
- GCT1042-02
- Conditions
- Non-CNS Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After reviewing all available data from Part 1 of the trial, the Sponsor has decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.
Detailed description
The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization).
Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2.
Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1.
Participants in both parts are treated with one of the following combinations:
- Radiotherapy + GEN1042
- Radiotherapy + GEN1042 + Pembrolizumab
While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1 is sequential, Part 2 is parallel (randomized)
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + GEN1042 | Experimental | Biological: GEN1042, Radiation: Radiotherapy |
| Radiotherapy + GEN1042 + Pembrolizumab | Experimental | Biological: GEN1042, Drug: Pembrolizumab, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy.
- At least 18 years of age.
- Signed informed consent prior to any screening procedures.
- Measurable disease according to RECIST v1.1.
- Life expectancy of >3 months.
Key exclusion criteria (10 listed)
- Prior malignancy except for non-melanoma skin cancers and in situ cancers.
- Condition contraindicating radiotherapy.
- Rapidly progressing disease.
- Active, known or suspected autoimmune disease.
- History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEN1042Intravenous | Biological | Radiotherapy + GEN1042, Radiotherapy + GEN1042 + Pembrolizumab |
| PembrolizumabIntravenous | Drug | Radiotherapy + GEN1042 + Pembrolizumab |
| RadiotherapyRadiotherapy | Radiation | Radiotherapy + GEN1042, Radiotherapy + GEN1042 + Pembrolizumab |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: 21 days
A DLT was defined as any grade 5 toxicity, treatment-related toxicity that caused the participant to discontinue treatment during Cycle 1, febrile neutropenia grade 3 or grade 4, grade 3 thrombocytopenia associated with clinically significant bleeding, grade 4 thrombocytopenia of any duration, grade 4 anemia, any grade ≥3 non-hematologic clinical (non-laboratory) toxicity with exceptions per protocol, any grade 3 or grade 4 non-hematologic laboratory value if clinically significant medical intervention was required to treat the participant or the abnormality led to hospitalization, or the abnormality persisted for >7 days, and the abnormality resulted in a drug-induced liver injury (DILI) as defined by Hy's Law. Toxicities were graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years 5 months
Duration of Response (DOR)
Time frame: Up to approximately 2 years 5 months
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years 5 months
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years 5 months
Overall Survival (OS)
Time frame: Up to approximately 2 years 5 months
Number of Participants With Abscopal Response in Non-irradiated Target Lesions As Assessed by the Investigator
Time frame: Up to approximately 2 years 5 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years 5 months
Blood Concentration of GEN1042 Over Time
Time frame: At multiple timepoints (as described in the "Outcome Measure Description" field between Cycle 1 Day 1 up to Safety Follow Up [up to approximately Day 517]). Cycles were 21 days in length.
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to approximately 2 years 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results Summary in Plain LanguageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Official study director
Genmab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GEN1042, Pembrolizumab and Radiotherapy in people with Non-CNS Tumor, run by Genmab at 2 sites in France.
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 8 inclusion and 10 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.