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GEN1047 for Bladder Cancer

Yale University - Yale Cancer Center, New Haven, CT
Bladder Cancer+11 More ConditionsGEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive cells. - Biological
Eligibility
18+
All Sexes

Study Summary

This trial studies the safety and effectiveness of an antibody, GEN1047, in treating cancer. Participants will get GEN1047 in two parts to assess safety, dose and preliminary activity.

Eligible Conditions
  • Bladder Cancer
  • Head and Neck Cancer
  • Non-Small Cell Lung Cancer
  • Uterine Cancer
  • Squamous Cell Carcinoma of the Lung
  • Cervical Cancer
  • Ovarian Cancer
  • Bile Duct Cancer
  • Breast Cancer
  • Endometrial Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

7 Primary · 23 Secondary · Reporting Duration: Up to 5 years

Day 30
Escalation and expansion: Evaluate immunogenicity of GEN1047
Escalation and expansion: To characterize the PK properties of GEN1047
Escalation and expansion: To characterize the pharmacokinetic (PK) properties of GEN1047
Escalation: Number of participants with clinically significant shifts from baseline in clinical laboratory parameters
Expansion: AEs
Expansion: Number of participants with clinically significant shifts from baseline in clinical laboratory parameters
Day 21
Escalation: Dose Limiting Toxicities (DLTs)
Day 30
Escalation: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Expansion: Number of Participants with TEAEs
Day 21
Escalation: Number of Participants with Dose Limiting Toxicities
Day 21
Escalation and Expansion: Area Under the Concentration-time Curve from Time 0 to Time of Last Dose (AUClast)
Escalation and Expansion: Clearance
Escalation and Expansion: Elimination half-life (t 1/2)
Escalation and Expansion: Maximum (Peak) Plasma Concentration (Cmax)
Escalation and Expansion: Plasma Trough (Pre-dose) Concentrations (Cthrough)
Escalation and Expansion: Time to Reach Cmax (Tmax)
Escalation and Expansion: Volume of Distribution (Vd)
Year 5
Escalation and expansion: Evaluate preliminary anti-tumor activity of GEN1047 (efficacy)
Escalation: Evaluate anti-tumor activity of GEN1047
Expansion: Evaluate anti-tumor activity of GEN1047
Year 5
Expansion: Evaluate preliminary efficacy of GEN1047
Day 30
Escalation: Adverse Events (AEs)
Up to 5 years
Escalation and Expansion: Disease control rate (DCR)
Escalation and Expansion: Duration of Response (DOR)
Escalation and Expansion: Number of Participants with Anti-Drug Antibody (ADA)
Escalation and Expansion: Time to response (TTR)
Escalation: ORR
Expansion: Objective Response Rate (ORR)
Expansion: Overall Survival (OS)
Expansion: Progression Free Survival (PFS)

Trial Safety

Phase-Based Safety

1 of 3

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1
AG-01 treated group phase 1A
1
YL202 Dose escalation
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

GEN1047
1 of 2
Treatment
1 of 2

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: GEN1047 · No Placebo Group · Phase 1 & 2

GEN1047
Biological
Experimental Group · 1 Intervention: GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive cells. · Intervention Types: Biological
Treatment
Biological
Experimental Group · 1 Intervention: GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive cells. · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

GenmabLead Sponsor
51 Previous Clinical Trials
9,794 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must have an advanced or metastatic diagnosis of breast cancer, uterine cancer, ovarian cancer, NSCLC-SCC which is pathologically confirmed and for whom there is no more standard therapy that would be beneficial
You have experienced recurrence after, or progression on or lack of response to SOC anticancer therapies; are deemed intolerant to standard curative therapy in the recurrent setting; or ineligible for it.
References

Frequently Asked Questions

Is this particular trial actively seeking participants?

"According to clinicaltrials.gov, the search for participants is still ongoing - this trial was initially advertised on December 13th 2021 and has been regularly updated ever since its inception on April 19th 2023." - Anonymous Online Contributor

Unverified Answer

What is the participant count of this experiment?

"Affirmative. Clinicaltrials.gov data confirms that this research project, which was originally posted on December 13th 2021 is actively recruiting participants. Five hundred patients need to be enrolled at 8 different medical centres." - Anonymous Online Contributor

Unverified Answer

How many research sites are undertaking this trial?

"8 clinical sites, located in Nashville, Pamplona and Paris amongst other cities, are running this trial. When considering participation, it is best to select the nearest location so as to reduce travel time." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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