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Monoclonal Antibodies

GEN1046 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Both Dose Escalation and Expansion: Have Eastern Cooperative Oncology Group (ECOG) 0-1

For Both Dose Escalation and Expansion: Have acceptable coagulation status

Must not have

Have uncontrolled intercurrent illness, including but not limited to: History of irAEs that led to prior checkpoint treatment discontinuation

Have uncontrolled intercurrent illness, including but not limited to: History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of acasunlimab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, GEN1046, to see if it is safe to use alone or with other drugs to treat cancer.

Who is the study for?

This trial is for adults with certain advanced cancers (like lung, breast, bladder, or cervical cancer) that have relapsed or spread and can't be treated with standard therapies anymore. They should be in good physical condition (ECOG 0-1), have tumors that can be measured by scans, and their organs must function well. People who've had recent serious illnesses, infections needing IV drugs, severe side effects from immune treatments before, heart problems, uncontrolled blood pressure or autoimmune diseases cannot join.

What is being tested?

The trial tests acasunlimab alone and combined with other cancer drugs like docetaxel and pembrolizumab to see how safe they are for treating various solid tumors. It has two parts: dose escalation to find the right amount of drug to give safely and expansion where more people get the treatment at this dose to further check safety.

What are the potential side effects?

While specific side effects aren't listed here, typical ones for cancer immunotherapies may include fatigue, skin reactions, inflammation in different body parts like lungs or intestines (which might cause coughing or diarrhea), hormonal imbalances and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My blood clotting ability is within normal ranges.

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My blood test results are within normal ranges.

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I have a cancer that has spread and cannot be surgically removed, with no standard treatment options left.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I stopped a cancer treatment due to severe side effects.

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I haven't had any major organ or bone marrow transplants in the last 3 months.

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I do not have severe heart problems like heart failure, chest pain, or irregular heartbeat.

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I do not have any serious, non-healing wounds, skin ulcers, or bone fractures.

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I do not have any illnesses that are not under control, including high blood pressure.

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I do not have ongoing serious illnesses like myositis, Guillain-Barré syndrome, or myasthenia gravis.

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I do not have any ongoing infections requiring IV treatments.

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I do not have an ongoing illness like pneumonitis that needed steroids.

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I do not have chronic liver disease or cirrhosis.

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I do not have an active autoimmune disease.

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Side effects from my past cancer treatments have not fully gone away.

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I do not have any uncontrolled illnesses like recent brain issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT)

Expansion Cohort 1: Objective Response Rate (ORR)

Secondary study objectives

All Parts: Duration of Response (DoR)

All Parts: Number of Participants with Anti-drug Antibodies (ADAs)

Dose Escalation and Expansion Cohorts 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13: Disease Control Rate (DCR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ExpansionExperimental Treatment4 Interventions

Acasunlimab will be administered as monotherapy or in combination with either docetaxel, pembrolizumab, or pembrolizumab + standard chemotherapy in separate expansion cohorts.

Group II: Dose EscalationExperimental Treatment1 Intervention

Acasunlimab will be administered as monotherapy.

0 / 16Eligibility criteria met