A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors

Genmab

Status and phase: Enrolling; Phase 1

Conditions: Malignant Solid Tumor

Treatments: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Biological: GEN1042; Drug: 5-Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT06057038

GCT1042-03

jRCT2031230438 (Registry Identifier)

Details and patient eligibility

About

This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants. The main purpose is to assess the safety and tolerability of GEN1042 monotherapy or GEN1042 in combination in Japanese study participants with cancer.

Full description

This is an open-label, trial to evaluate the safety and tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of GEN1042 in Japanese participants with malignant solid tumors. The trial consists of 2 parts: a GEN1042 Monotherapy Dose Escalation Part (phase 1a); and a Combination Therapy Part (phase 1b).

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).

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Must have measurable disease according to RECIST v1.1.
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.

Key Exclusion Criteria:

1. Has clinically significant toxicities from previous anticancer therapies.
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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

42 participants in 5 patient groups

Monotherapy (non-CNS Malignant Solid Tumors): GEN1042

Experimental group

Treatment:

Biological: GEN1042

Combination Therapy Cohort 1 [HNSCC]: GEN1042+Pembro+Chemotherapy

Experimental group

Treatment:

Drug: 5-Fluorouracil

Biological: GEN1042

Drug: Cisplatin

Drug: Carboplatin

Drug: Pembrolizumab

Combination Therapy Cohort 2 [HNSCC and NSCLC]: GEN1042+Pembro

Experimental group

Treatment:

Biological: GEN1042

Drug: Pembrolizumab

Combination Therapy Cohort 3 [HNSCC]: GEN1042+Pembro+Chemotherapy

Experimental group

Treatment:

Drug: 5-Fluorouracil

Biological: GEN1042

Drug: Cisplatin

Drug: Carboplatin

Drug: Pembrolizumab

Combination Therapy Cohort 4 [HNSCC and NSCLC]: GEN1042+Pembro

Experimental group

Treatment:

Biological: GEN1042

Drug: Pembrolizumab