Clinical trial NCT06057038: A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GEN1042 Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Japanese Subjects With Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Malignant Solid Tumor
Lead sponsor: Genmab
Sponsor class: INDUSTRY
Collaborators: name: BioNTech SE
First posted: 2023-09-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: During the first cycle (Cycle length = 21 days)
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: From first dose until the end of the treatment (approximately 3 years)
Secondary outcomes:
measure: Maximum (Peak) Plasma Concentration (Cmax) of GEN1042
timeFrame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
measure: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN1042
timeFrame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
measure: Time to Reach Cmax (Tmax) of GEN1042
timeFrame: Predose and postdose at multiple timepoints up to end of treatment (approximately 3 years)
measure: Number of Participants with Anti-drug Antibodies (ADA) to GEN1042
timeFrame: up to 3 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 3 years
measure: Duration of Response (DOR)
timeFrame: Up to 3 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 3 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: National Cancer Center East
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
Study officials:
affiliation: Genmab
name: Study Official
role: STUDY_DIRECTOR
References: