Metastatic Uveal MelanomaPhase 1/2NCT05415072
A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas
A Phase 1/2 study testing DYP688 in people with Metastatic Uveal Melanoma, run by Novartis Pharmaceuticals at 11 sites in 7 countries.
Trial summary
This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas harboring GNAQ/11 mutations. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metastatic Uveal Melanoma
- What is being tested?
- DYP688
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 4 Jul 2022to 1 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the dose escalation part must be ≥ 18 years of age at the time of informed consent (ICF) signature. In the phase II part, patients ≥ 12 years of age at the time of informed consent may be eligible for enrollment (not applicable in countries where enrollment is restricted by the local health authority to patients ≥ 18 years of age). Patients must have a minimum weight of 40 kg.
- 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
- Patients must be suitable and willing to undergo study required biopsies according to the treating institution's own guidelines and requirements. If a biopsy is not medically feasible, exceptions may be considered after documented discussion with Novartis.
- For all patients in Dose Escalation
- MUM: uveal melanoma with histologically or cytologically confirmed metastatic disease. Patient must be either treatment naive or have received any number of prior lines and progressed on most recent therapy
- Non-MUM: advanced cutaneous or mucosal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following all standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 mutation based on local data
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- For patients in Phase II
- Tebentafusp naïve group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies
- Tebentafusp pre-treated group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease. Patients must be previously treated with tebentafusp and have progressed
- Non-MUM: patients with diagnosis of cutaneous or mucosal melanomas harboring GNAQ/11 mutations based on local data, with histologically or cytologically confirmed metastatic disease that has progressed following all standard therapies or that has no satisfactory alternative therapies
Who cannot join
- Malignant disease, other than that being treated in this study.
- Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease.
- Evidence of active bleeding or bleeding diathesis or significant coagulopathy (including familial) or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
- History of anaphylactic or other severe hypersensitivity / infusion reactions to ADCs or monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
- Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
- 2 weeks for fluoropyrimidine therapy
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- 4 weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment.
- 4 weeks or ≤ 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
- 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosoureas and mitomycin C.
- 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.
- Clinically significant and / or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA grade ≥ 2) or clinically significant arrhythmia despite medical treatment.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Columbia University Medical Center
New York, New York, 10032
Memorial Sloane Ketterin Cancer Ctr
New York, New York, 10065
Australia2 sites
Novartis Investigative Site
Melbourne, Victoria, 3000
Novartis Investigative Site
Westmead, New South Wales, 2145
Germany2 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Heidelberg, 69120
Netherlands1 site
Novartis Investigative Site
Leiden, South Holland, 2333 ZA
About this study
Official title: A Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas
This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas harboring GNAQ/11 mutations.
Read the detailed description
This is a First in Human (FIH), phase I/II, open label, multi-center study of DYP688 as a single agent. There will be two parts to this study: a phase I, dose escalation part followed by a phase II part. Dose escalation will be conducted in patients with MUM and other melanomas harboring GNAQ/11 mutations. Once the MTD and/or RD(s) is determined in the dose escalation part, the study may continue with a phase II part. The phase II part will be conducted in two groups of patients with MUM, a prior tebentafusp-treated group and a tebentafusp-naïve group. In addition to MUM, a third group of patients with non-uveal GNAQ/11 mutant melanomas may also be explored. This cohort may be opened based on emerging data from the dose escalation part of the study.
- Conditions
- Metastatic Uveal Melanoma
- Being tested
- DYP688
- Keywords
- Phase I/II, DYP688, melanoma, GNAQ/11 mutations, cancer, malignant melanoma, eye cancer, ocular melanoma, uveal melanoma, cutaneous melanoma, mucosal melanoma, neoplasms, eye
- Medical subject headings
- Uveal Melanoma, Melanoma, Neoplasms, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DYP688Drug
Single agent DYP688
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation | Experimental | Patients with metastatic uveal melanoma or other GNAQ/11 mutant melanomas Receives: Drug: DYP688 |
| Phase II: Tebe naive group | Experimental | Patients with metastatic uveal melanoma that has not received prior treatment with tebentafusp Receives: Drug: DYP688 |
| Phase II: Tebe pre-treated | Experimental | Patients with metastatic uveal melanoma that have been previously treated with tebentafusp Receives: Drug: DYP688 |
| Phase II: Non-uveal melanoma | Experimental | Optional Arm: To explore patients with non-uveal melanoma that harbor GNAQ or 11 mutations, based on emerging data from dose escalation Receives: Drug: DYP688 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I (Dose Escalation): Incidence and severity of dose limiting toxicities (DLTs) during the first 28 days of treatment.
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with DYP688. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Measured: 28 days
Phase I (Dose Escalation): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Assessment of safety of DYP688 as a single agent
Measured: 9 months
Phase I (Dose Escalation): Frequency of dose interruptions, reductions, and discontinuations
Assessment of tolerability of DYP688 as a single agent
Measured: 9 months
Phase II: Overall Response rate (ORR) per RECIST 1.1
ORR in Phase II will be evaluated by central review per RECIST 1.1.
Measured: 17 months
Secondary outcomes (13)
Phase I and Phase II: PK profile of DYP688 - Area under the concentration-time curve (AUC)
Pharmacokinetic (PK) parameters will be determined by non-compartmental methods using pharmacokinetic profile of DYP688.
Measured: 26 months
Phase I and Phase II: PK profile of DYP688 - Peak concentration (Cmax)
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of DYP688.
Measured: 26 months
Phase I and Phase II: PK profile of DYP688 - Total body clearance (CL)
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of DYP688.
Measured: 26 months
Phase I and Phase II: PK profile of DYP688 - Elimination half-life
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of DYP688.
Measured: 26 months
Phase I and Phase II: Prevalence and incidence of anti-DYP688 antibodies
Assess of immunogenicity (IG) of DYP688 as a single agent
Measured: 26 months
Phase I (Dose Escalation): Best Overall Response (BOR) per RECIST v1.1
Evaluation of preliminary anti-tumor activity of DYP688 as a single agent
Measured: 9 months
Phase I (Dose Escalation): Overall Response Rate (ORR) per RECIST v1.1
Evaluation of preliminary anti-tumor activity of DYP688 as a single agent
Measured: 17 months
Phase II: Duration of response (DoR) per RECIST v1.1
Evaluation of anti-tumor activity of DYP688 as a single agent
Measured: 17 months
Phase II: Progression free survival (PFS) per RECIST v1.1
Evaluation of anti-tumor activity of DYP688 as a single agent
Measured: 17 months
Phase II: Disease Control Rate (DCR) per RECIST v1.1
Evaluation of anti-tumor activity of DYP688 as a single agent
Measured: 17 months
Phase II: Overall Survival (OS)
Evaluation of the effect of DYP688 as a single agent on overall survival
Measured: 17 months
Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Assessment of safety of DYP688 as a single agent
Measured: 17 months
Phase II: Frequency of dose interruptions, reductions, and discontinuations
Assessment of tolerability of DYP688 as a single agent
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start4 Jul 2022
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415072
- Sponsor's protocol ID
- CDYP688A12101
- Other IDs
- 2021-003380-95
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carlino MS, Kapiteijn E, Piperno-Neumann S, Sullivan RJ, Carvajal R, Dummer R, Gromke T, Hassel JC, Kee D, Ramelyte E, Shoushtari AN, Wei AZ, Enk A, Handel EE, Montazeri K, Ramon-Patino J, Richly H, Rodrigues M, Sandhu S, Smithy J, Speetjens FM, Milanez-Almeida P, Chaudhury A, Hoffmaster K, Ising M, Otero JA, RamKumar T, Reynolds A, Sharaby S, Werner L, Yerramilli-Rao P, Calvo E. An anti-PMEL antibody-drug conjugate with a Gq/11 inhibitor payload in GNAQ/GNA11-mutant melanomas: a phase 1 trial. Nat Med. 2026 Jul 13. doi: 10.1038/s41591-026-04518-z. Online ahead of print.
PubMed 42443515
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas
- ClinicalTrials.gov ID
- NCT05415072
- Acronym / sponsor ID
- CDYP688A12101
- Conditions
- Metastatic Uveal Melanoma
- Keywords
- Phase I/II, DYP688, melanoma, GNAQ/11 mutations, cancer, malignant melanoma, eye cancer, ocular melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas harboring GNAQ/11 mutations.
Detailed description
This is a First in Human (FIH), phase I/II, open label, multi-center study of DYP688 as a single agent. There will be two parts to this study: a phase I, dose escalation part followed by a phase II part. Dose escalation will be conducted in patients with MUM and other melanomas harboring GNAQ/11 mutations. Once the MTD and/or RD(s) is determined in the dose escalation part, the study may continue with a phase II part. The phase II part will be conducted in two groups of patients with MUM, a prior tebentafusp-treated group and a tebentafusp-naïve group. In addition to MUM, a third group of patients with non-uveal GNAQ/11 mutant melanomas may also be explored. This cohort may be opened based on emerging data from the dose escalation part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Escalation | Experimental | Drug: DYP688Patients with metastatic uveal melanoma or other GNAQ/11 mutant melanomas |
| Phase II: Tebe naive group | Experimental | Drug: DYP688Patients with metastatic uveal melanoma that has not received prior treatment with tebentafusp |
| Phase II: Tebe pre-treated | Experimental | Drug: DYP688Patients with metastatic uveal melanoma that have been previously treated with tebentafusp |
| Phase II: Non-uveal melanoma | Experimental | Drug: DYP688Optional Arm: To explore patients with non-uveal melanoma that harbor GNAQ or 11 mutations, based on emerging data from dose escalation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients in the dose escalation part must be ≥ 18 years of age at the time of informed consent (ICF) signature. In the phase II part, patients ≥ 12 years of age at the time of informed consent may be eligible for enrollment (not applicable in countries where enrollment is restricted by the local health authority to patients ≥ 18 years of age). Patients must have a minimum weight of 40 kg.
- 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
- Patients must be suitable and willing to undergo study required biopsies according to the treating institution's own guidelines and requirements. If a biopsy is not medically feasible, exceptions may be considered after documented discussion with Novartis.
- For all patients in Dose Escalation
- MUM: uveal melanoma with histologically or cytologically confirmed metastatic disease. Patient must be either treatment naive or have received any number of prior lines and progressed on most recent therapy
Key exclusion criteria (12 listed)
- Malignant disease, other than that being treated in this study.
- Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease.
- Evidence of active bleeding or bleeding diathesis or significant coagulopathy (including familial) or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
- History of anaphylactic or other severe hypersensitivity / infusion reactions to ADCs or monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
- Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DYP688Single agent DYP688 | Drug | Phase I: Dose Escalation, Phase II: Non-uveal melanoma, Phase II: Tebe naive group, Phase II: Tebe pre-treated |
Primary outcome
Phase I (Dose Escalation): Incidence and severity of dose limiting toxicities (DLTs) during the first 28 days of treatment.
Time frame: 28 days
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with DYP688. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Phase I (Dose Escalation): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 9 months
Assessment of safety of DYP688 as a single agent
Phase I (Dose Escalation): Frequency of dose interruptions, reductions, and discontinuations
Time frame: 9 months
Assessment of tolerability of DYP688 as a single agent
Phase II: Overall Response rate (ORR) per RECIST 1.1
Time frame: 17 months
ORR in Phase II will be evaluated by central review per RECIST 1.1.
13 secondary outcomes
Phase I and Phase II: PK profile of DYP688 - Area under the concentration-time curve (AUC)
Time frame: 26 months
Phase I and Phase II: PK profile of DYP688 - Peak concentration (Cmax)
Time frame: 26 months
Phase I and Phase II: PK profile of DYP688 - Total body clearance (CL)
Time frame: 26 months
Phase I and Phase II: PK profile of DYP688 - Elimination half-life
Time frame: 26 months
Phase I and Phase II: Prevalence and incidence of anti-DYP688 antibodies
Time frame: 26 months
Phase I (Dose Escalation): Best Overall Response (BOR) per RECIST v1.1
Time frame: 9 months
Phase I (Dose Escalation): Overall Response Rate (ORR) per RECIST v1.1
Time frame: 17 months
Phase II: Duration of response (DoR) per RECIST v1.1
Time frame: 17 months
Phase II: Progression free survival (PFS) per RECIST v1.1
Time frame: 17 months
Phase II: Disease Control Rate (DCR) per RECIST v1.1
Time frame: 17 months
Phase II: Overall Survival (OS)
Time frame: 17 months
Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 17 months
Phase II: Frequency of dose interruptions, reductions, and discontinuations
Time frame: 17 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Derived from this study: PubMed 42443515Carlino MS, Kapiteijn E, Piperno-Neumann S, Sullivan RJ, Carvajal R, Dummer R, Gromke T, Hassel JC, Kee D, Ramelyte E, Shoushtari AN, Wei AZ, Enk A, Handel EE, Montazeri K, Ramon-Patino J, Richly H, Rodrigues M, Sandhu S, Smithy J, Speetjens FM, Milanez-Almeida P, Chaudhury A, Hoffmaster K, Ising M, Otero JA, RamKumar T, Reynolds A, Sharaby S, Werner L, Yerramilli-Rao P, Calvo E. An anti-PMEL antibody-drug conjugate with a Gq/11 inhibitor payload in GNAQ/GNA11-mutant melanomas: a phase 1 trial. Nat Med. 2026 Jul 13. doi: 10.1038/s41591-026-04518-z. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DYP688 in people with Metastatic Uveal Melanoma, run by Novartis Pharmaceuticals at 11 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, Germany, France, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I (Dose Escalation): Incidence and severity of dose limiting toxicities (DLTs) during the first 28 days of treatment. (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.