GEN1042 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cancer+5 MoreGEN1042 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how safe and effective GEN1042 is in treating patients with metastatic or locally advanced solid tumors.

Eligible Conditions
  • Cancer
  • Non-Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Pancreatic Cancer
  • Colorectal Cancer
  • Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 19 Secondary · Reporting Duration: From the start of study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial.

Day 90
Dose Expansion: Incidence of ADA response to GEN1042
Dose Expansion: Percentage of Participants with Incidence of ADA response to GEN104
Day 90
Dose Escalation: Incidence of ADA response to GEN1042
Dose Escalation: Percentage of Participants with Incidence of anti-drug antibody (ADAs) responses to GEN1042
Month 36
Incidence of Adverse Events and Serious Adverse Events as assessed by NCI CTCAE V5.0 for GEN1042 administered alone (phase 1a) and in combination regimen (phase 1b)
Incidence of Adverse Events and Serious Adverse Events as assessed by NCI CTCAE V5.0 for dose expansion as monotherapy (phase 2a) and in combination (phase 2b)
Percentage of Subjects with Adverse Events and Serious Adverse Events
Month 36
Best Overall Response Rate (ORR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for dose expansion as monotherapy (phase 2a) and in combination (phase 2b)
Duration of Object Response (DOR) determined by Investigator per RECIST 1.1. for dose expansion as monotherapy (phase 2a) and in combination (phase 2b)
Progression-Free Survival (PFS) determined by Investigator using RECIST 1.1 for dose expansion as monotherapy (phase 2a) and in combination (phase 2b)
Day 21
Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042
Dose Expansion: Maximum Concentration (Cmax) of GEN1042
Day 21
Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042
Day 21
Dose Escalation: Half-life (t1/2) of GEN1042
Dose Escalation: Maximum Concentration (Cmax) of GEN1042
First Cycle (21 days)
Dose Limiting Toxicity (DLT)
Percentage of Subjects With Dose-Limiting Toxicities (DLT)
Month 36
Maximum Tolerated Dose (MTD) assessed as the highest dose of GEN1042 administered alone (phase 1a) or in combination regimen (phase 1b)
Occurrence of Dose-Limiting Toxicities (DLT) assessed by the Investigator to be possibly, probably or definitely related to GEN1042 (phase 1a) and GEN1042 combination regimen (phase 1b)
Recommended Phase 2 Dose (RP2D) based on available safety and dosing information of GEN1042 administered alone (phase 1a) and in combination regimen (phase 1b)
Month 36
Overall survival assessed from the start of study treatment to death for dose expansion as monotherapy (phase 2a) and in combination (phase 2b)
Month 36
Overall survival (OS)
Month 10
Progression-Free Survival (PFS)
Month 10
Disease Control Rate (DCR)
Duration of Object Response (DOR)
Objective Response Rate (ORR)
Month 2
Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

12 Treatment Groups

Combination Therapy - Dose Expansion Part
1 of 12
Monotherapy - Dose Escalation and Dose Expansion parts
1 of 12
Combination therapy expansion (phase 2b) for PDAC
1 of 12
Combination safety run-in (phase 1b) for HNSCC
1 of 12
Combination therapy expansion (phase 2b) for HNSCC with pembrolizumab + chemothe...
1 of 12
GEN1042 monotherapy expansion (phase 2a)
1 of 12
GEN1042 monotherapy dose escalation (phase 1a)
1 of 12
Combination therapy expansion (phase 2b) for NSCLC
1 of 12
Combination safety run-in (phase 1b) for NSCLC, HNSCC and Melanoma
1 of 12
Combination safety run-in (phase 1b) for PDAC
1 of 12
Combination therapy expansion (phase 2b) for Melanoma
1 of 12
Combination therapy expansion (phase 2b) for HNSCC with pembrolizumab
1 of 12

Experimental Treatment

647 Total Participants · 12 Treatment Groups

Primary Treatment: GEN1042 · No Placebo Group · Phase 1 & 2

Combination Therapy - Dose Expansion PartExperimental Group · 9 Interventions: Paclitaxel, 5-FU, Nab paclitaxel, Pemetrexed, Pembrolizumab, Cisplatin, Gemcitabine, GEN1042, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Biological, Drug
Monotherapy - Dose Escalation and Dose Expansion parts
Biological
Experimental Group · 1 Intervention: GEN1042 · Intervention Types: Biological
Combination therapy expansion (phase 2b) for PDACExperimental Group · 4 Interventions: Pembrolizumab, Gemcitabine, GEN1042, Nab-Paclitaxel · Intervention Types: Drug, Drug, Biological, Drug
Combination safety run-in (phase 1b) for HNSCCExperimental Group · 5 Interventions: 5-FU, Pembrolizumab, Cisplatin, GEN1042, Carboplatin · Intervention Types: Drug, Drug, Drug, Biological, Drug
Combination therapy expansion (phase 2b) for HNSCC with pembrolizumab + chemotherapyExperimental Group · 5 Interventions: 5-FU, Pembrolizumab, Cisplatin, GEN1042, Carboplatin · Intervention Types: Drug, Drug, Drug, Biological, Drug
GEN1042 monotherapy expansion (phase 2a)
Biological
Experimental Group · 1 Intervention: GEN1042 · Intervention Types: Biological
GEN1042 monotherapy dose escalation (phase 1a)
Biological
Experimental Group · 1 Intervention: GEN1042 · Intervention Types: Biological
Combination therapy expansion (phase 2b) for NSCLCExperimental Group · 2 Interventions: Pembrolizumab, GEN1042 · Intervention Types: Drug, Biological
Combination safety run-in (phase 1b) for NSCLC, HNSCC and MelanomaExperimental Group · 2 Interventions: Pembrolizumab, GEN1042 · Intervention Types: Drug, Biological
Combination safety run-in (phase 1b) for PDACExperimental Group · 4 Interventions: Pembrolizumab, Gemcitabine, GEN1042, Nab-Paclitaxel · Intervention Types: Drug, Drug, Biological, Drug
Combination therapy expansion (phase 2b) for MelanomaExperimental Group · 2 Interventions: Pembrolizumab, GEN1042 · Intervention Types: Drug, Biological
Combination therapy expansion (phase 2b) for HNSCC with pembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, GEN1042 · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~6440
5-FU
2006
Completed Phase 3
~4000
Pemetrexed
2014
Completed Phase 3
~5050
Pembrolizumab
FDA approved
Cisplatin
FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the start of study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial.

Who is running the clinical trial?

BioNTech SEIndustry Sponsor
51 Previous Clinical Trials
90,301 Total Patients Enrolled
GenmabLead Sponsor
44 Previous Clinical Trials
8,232 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are receiving a combination therapy regimen with a dose expansion component.
You have unresectable Stage III or IV melanoma without prior systemic anticancer therapy for inoperable or metastatic disease, excluding primary ocular and mucosal melanomas.
Subjects must have a confirmed diagnosis of metastatic Pancreatic Ductal Adenocarcinoma who have not undergone radiotherapy, surgery, chemotherapy or any other investigational therapy for the treatment of their metastasis.
You are receiving monotherapy at a dose that is escalating or expanding.
Individuals with non-central nervous system solid tumors that are both metastatic and unresectable, for whom there is no available conventional treatment.
You have a diagnosed case of relapsed or intractable, advanced and/or metastatic melanoma, NSCLC, or CRC for which there is no available customary treatment.
You have Stage IV metastatic or recurrent non-small cell lung cancer, with no prior systemic anticancer treatment and without any mutations that can be targeted.
You have recurrent or metastatic head and neck squamous cell carcinoma with no prior systemic therapy in the recurrence/metastasis setting, and you show programmed death ligand-1 immunohistochemistry combined positive score of 1 or greater.
Your disease can be accurately measured according to the Response Evaluation Criteria in Solid Tumors 1.1 criteria.
You must be 18 years of age or older.