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GNS561 + Trametinib for Bile Duct Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Genfit

Eligibility Criteria Checklist

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

Must have

Patients greater than or equal to 18 years of age.

Performance status (ECOG) 0-1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 42 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called GNS561 in combination with trametinib for people with advanced KRAS mutated cholangiocarcinoma. The trial will look at the safety,

Who is the study for?

This trial is for adults over 18 with advanced bile duct cancer (cholangiocarcinoma) that has a KRAS mutation and has worsened despite chemotherapy. Participants must have at least one measurable disease, be in good physical condition (ECOG 0-1), and have normal organ function. Women of childbearing age must test negative for pregnancy and use birth control; men must agree to contraception methods.

What is being tested?

The study tests the combination of two drugs, GNS561 and Trametinib, on patients with cholangiocarcinoma who've had no success with first-line therapy. It's an early-phase trial assessing safety, how the body processes the drugs, their effects on the body, and their effectiveness against this type of cancer.

What are the potential side effects?

Potential side effects may include issues related to liver function due to GNS561's targeting mechanism as well as skin rash or heart problems from Trametinib since it affects cell growth pathways.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My bile duct cancer has a KRAS mutation.

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My condition cannot be cured with current treatments.

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My blood counts and organ functions are within normal ranges.

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I have undergone at least one chemotherapy treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 42 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b)

Objective response rate (ORR) of the combination of GNS561 with trametinib (Phase 2a)

Secondary study objectives

Disease Control Rate (DCR)

Duration of response (DoR)

Incidence and severity of treatment emergent adverse event (TEAEs), incidence of serious adverse events (SAEs), incidence of TRAEs, incidence of adverse events of special interest (AESIs), rate of treatment discontinuation or interruption for TRAEs

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: GNS561+TrametinibExperimental Treatment1 Intervention

Phase 1b Dose Finding Patients will receive GNS561 (50mg QD; 100mg QD; 150mg; 200mg QD) and trametinib (2mg QD; 1.5mg QD; 1mg QD) in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD) of the combination. Experimental: Phase 2a Patients will receive GNS561 and trametinib at the recommended dose of the combination determined during Phase 1b

0 / 6Eligibility criteria met