A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
NCT ID: NCT06057038
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2023-11-24
2026-11-28
Brief Summary
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Detailed Description
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The purpose of Dose Escalation Part (phase 1a) is to evaluate GEN1042 as monotherapy in participants with non-central nervous system (non-CNS) malignant solid tumors.
The Combination Therapy Part (phase 1b) will evaluate GEN1042 in combination with pembrolizumab (pembro) or pembro along with the standard of care (SOC) chemotherapy in participants with head and neck squamous cell carcinoma (HNSCC) and non-small-cell lung cancer (NSCLC).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy (non-CNS Malignant Solid Tumors): GEN1042
GEN1042
Intravenous
Combination Therapy Cohort 1 [HNSCC]: GEN1042+Pembro+Chemotherapy
GEN1042
Intravenous
Pembrolizumab
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
5-Fluorouracil
Intravenous
Combination Therapy Cohort 2 [HNSCC and NSCLC]: GEN1042+Pembro
GEN1042
Intravenous
Pembrolizumab
Intravenous
Combination Therapy Cohort 3 [HNSCC]: GEN1042+Pembro+Chemotherapy
GEN1042
Intravenous
Pembrolizumab
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
5-Fluorouracil
Intravenous
Combination Therapy Cohort 4 [HNSCC and NSCLC]: GEN1042+Pembro
GEN1042
Intravenous
Pembrolizumab
Intravenous
Interventions
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GEN1042
Intravenous
Pembrolizumab
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
5-Fluorouracil
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
3. Acceptable organ and bone marrow function.
4. Participant must have a life expectancy of at least 3 months.
Exclusion Criteria
2. Has rapidly progressing disease.
3. Has a history of noninfectious pneumonitis/interstitial lung disease.
4. Has a history of liver disease.
5. Has had an allogeneic tissue/solid organ transplant or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042.
6. Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
7. Has had major surgery within 4 weeks before Screening.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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National Cancer Center East
Kashiwa, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Countries
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Other Identifiers
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jRCT2031230438
Identifier Type: REGISTRY
Identifier Source: secondary_id
GCT1042-03
Identifier Type: -
Identifier Source: org_study_id
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