GEN1042 safety trial in patients with malignant solid tumors

A first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety and anti-tumor activity of GEN1042 in subjects with malignant solid tumors

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003716-47-DK

Enrollment

647

Registered

2019-05-02

Start date

2019-07-02

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant solid tumors: Patients with relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC) who are not anymore candidates for standard therapy MedDRA version: 21.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: DuoBody- CD40xCD137 Product Code: GEN1042 Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: GEN1042 (DuoBody-CD40x4-1BB) CAS Number: 2253891-70-0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Monotherapy - Combination Therapy As defined in the protocol section exclusion criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 301 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 346

Exclusion criteria

Exclusion criteria: - Monotherapy - Combination Therapy As defined in the protocol section exclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: For dose escalation and safety run-in: • To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 administered alone or in combination with pembrolizumab with or without chemotherapy For dose expansion as monotherapy and in combination: • To evaluate the anti-tumor activity of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy;Secondary Objective: • To evaluate the safety and tolerability of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy • To evaluate the anti-tumor activity of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy • To characterize the pharmacokinetics (PK) and immunogenicity of GEN1042 administered as monotherapy or in combination with pembrolizumab with or without chemotherapy;Primary end point(s): For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment;Timepoint(s) of evaluation of this end point: As defined in the protocol section primary endpoint	—

Measure

Time frame

Main Objective: For dose escalation and safety run-in: • To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 administered alone or in combination with pembrolizumab with or without chemotherapy For dose expansion as monotherapy and in combination: • To evaluate the anti-tumor activity of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy;Secondary Objective: • To evaluate the safety and tolerability of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy • To evaluate the anti-tumor activity of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy • To characterize the pharmacokinetics (PK) and immunogenicity of GEN1042 administered as monotherapy or in combination with pembrolizumab with or without chemotherapy;Primary end point(s): For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment;Timepoint(s) of evaluation of this end point: As defined in the protocol section primary endpoint

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Secondary

Measure	Time frame
Secondary end point(s): - Adverse events (AEs) and safety laboratory parameters - ORR per RECIST 1.1 by investigator assessment (for dose escalation only) • Duration of response (DOR) per RECIST 1.1 by investigator assessment • Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment • Progression-free survival (PFS) per RECIST 1.1 by investigator assessment • OS - PK parameters and anti-drug antibodies (ADAs);Timepoint(s) of evaluation of this end point: As defined in the protocol section secondary endpoint	—

Measure

Time frame

Secondary end point(s): - Adverse events (AEs) and safety laboratory parameters - ORR per RECIST 1.1 by investigator assessment (for dose escalation only) • Duration of response (DOR) per RECIST 1.1 by investigator assessment • Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment • Progression-free survival (PFS) per RECIST 1.1 by investigator assessment • OS - PK parameters and anti-drug antibodies (ADAs);Timepoint(s) of evaluation of this end point: As defined in the protocol section secondary endpoint

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Countries

Australia, Denmark, Germany, Israel, Italy, Korea, Republic of, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Genmab A/S

clinicaltrials@genmab.com+4570202728

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026