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DYP688 for Metastatic Uveal Melanoma

Q: What positive outcomes does this clinical trial hope to bring about?

<p>The primary outcome of this trial will be evaluated over a 28 day period, and it is to Phase I (Dose Escalation): Frequency of dose interruptions, reductions, and discontinuations. Additionally, the secondary outcomes include Phase I and Phase II: PK profile of DYP688 - Total body clearance (CL), which is defined as Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of DYP688. Another secondary outcome is Phase I and Phase II: PK profile of DYP688 - Elimination half-life (t1/2), which is defined as Pharmac</p>

Q: Are researchers still recruiting participants for this trial?

<p>The clinical trial is actively recruiting participants, as indicated by the most recent update on October 10th, 2020. The study was originally posted on July 4th, 2020 and it is looking for 124 individuals total between 3 sites.</p>

Phase 1 & 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

ECOG performance status ≤ 1 for patients ≥ 18 years of age; Karnofsky performance status ≥ 70 for patients ≥ 16 and < 18 years of age; Lansky performance status ≥ 70 for patients ≥ 12 and < 16 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 months

Awards & highlights

Study Summary

This trial is testing a new drug, DYP688, to see if it is safe and effective at treating metastatic uveal melanoma, a type of skin cancer.

Who is the study for?

This trial is for patients with metastatic uveal melanoma or other melanomas with GNAQ/11 mutations. Adults and, in some cases, children over 12 can join if they weigh at least 40 kg and are healthy enough (good performance status). They must be willing to undergo biopsies unless medically inadvisable. Patients should not have active brain metastases, significant bleeding risks, recent cancer treatments that could interfere, other cancers, severe allergies to similar drugs, or uncontrolled heart disease.Check my eligibility

What is being tested?

The study is testing DYP688 as a single agent for its safety and effectiveness against certain types of advanced melanoma. It's an open-label trial meaning everyone knows what treatment they're getting. The first phase checks the right dose and the second phase sees how well it works on different groups including those who've had standard treatments or specific prior therapy.See study design

What are the potential side effects?

While specific side effects of DYP688 aren't listed here, common ones for cancer treatments like this may include fatigue, nausea, allergic reactions to the drug infusion itself (like fever or chills), potential bleeding issues due to biopsies especially in people with clotting problems.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am mostly active and can care for myself regardless of my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I (Dose Escalation): Frequency of dose interruptions, reductions, and discontinuations

Phase I (Dose Escalation): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Therapeutic procedure

+1 more

Secondary outcome measures

Phase I (Dose Escalation): Best Overall Response (BOR) per RECIST v1.1

Phase I (Dose Escalation): Overall Response Rate (ORR) per RECIST v1.1

Phase I and Phase II: PK profile of DYP688 - Area under the concentration-time curve (AUC)

+10 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase II: Tebe pre-treatedExperimental Treatment1 Intervention

Patients with metastatic uveal melanoma that have been previously treated with tebentafusp

Group II: Phase II: Tebe naive groupExperimental Treatment1 Intervention

Patients with metastatic uveal melanoma that has not received prior treatment with tebentafusp

Group III: Phase II: Non-uveal melanomaExperimental Treatment1 Intervention

Optional Arm: To explore patients with non-uveal melanoma that harbor GNAQ or 11 mutations, based on emerging data from dose escalation

Group IV: Phase I: Dose EscalationExperimental Treatment1 Intervention

Patients with metastatic uveal melanoma or other GNAQ/11 mutant melanomas

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,858 Previous Clinical Trials

4,197,719 Total Patients Enrolled

Media Library

Uveal Melanoma Research Study Groups: Phase I: Dose Escalation, Phase II: Tebe naive group, Phase II: Tebe pre-treated, Phase II: Non-uveal melanoma

Uveal Melanoma Clinical Trial 2023: DYP688 Highlights & Side Effects. Trial Name: NCT05415072 — Phase 1 & 2

DYP688 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415072 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What positive outcomes does this clinical trial hope to bring about?

"The primary outcome of this trial will be evaluated over a 28 day period, and it is to Phase I (Dose Escalation): Frequency of dose interruptions, reductions, and discontinuations. Additionally, the secondary outcomes include Phase I and Phase II: PK profile of DYP688 - Total body clearance (CL), which is defined as Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of DYP688. Another secondary outcome is Phase I and Phase II: PK profile of DYP688 - Elimination half-life (t1/2), which is defined as Pharmac"

Answered by AI

Are researchers still recruiting participants for this trial?

"The clinical trial is actively recruiting participants, as indicated by the most recent update on October 10th, 2020. The study was originally posted on July 4th, 2020 and it is looking for 124 individuals total between 3 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas

2022. "A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05415072.

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