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A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
EU CTIS ID: 2024-517150-10-00
What this study is testing
To evaluate the safety and tolerability, and define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab Part 3 Neoadjuvant Cohorts (Cohorts 3c and 3d): To evaluate the antitumor activity of TransCon TLR7/8 Agonist in combination with pembrolizumab
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Participants who have undergone treatment with anti-PD-1, anti-PDL1, or anti CTLA 4 antibody must have at least 4 weeks from the last dose of antibody and evidence of disease progression per investigator assessment before enrollment
- Part 3 HNSCC 1. Histologically confirmed squamous cell cancers, regardless of HPV or PD-L1 status. 2. Known HPV (for example, p16 IHC) status. 3. Participants must have received no more than 1 prior line of chemotherapy-based treatment for locally advanced, unresectable, recurrent or metastatic disease. a. Cetuximab is not considered chemotherapy in this protocol
- Part 3 Other HPV-Associated Tumor Types 1. Histologically confirmed anal, vulvar, cervical, penile or vaginal cancers. 2. Known HPV (for example, p16 IHC) status. 3. Participants must have received no more than 1 prior line of therapy (treatment regimen) for locally advanced, unresectable, recurrent or metastatic disease
- Part 3 Neoadjuvant Melanoma 1. Histologically or cytologically confirmed diagnosis of cutaneous melanoma belonging to one of the AJCC TNM stages. 2. No prior radiotherapy or systemic anticancer therapy for melanoma. 3. At least one measurable lesion per RECIST v1.1 that is ≥15 mm in the longest diameter at time of selection.
You likely can't join if
- Participants who have been previously treated with a TLR agonist (excluding topical agents for unrelated disease) are not eligible.
- Any uncontrolled bacterial, fungal, viral, or other infection.
- Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of first dosing on study is not allowed.
- Significant cardiac disease.
- A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated demonstration of a QTc interval >480 ms (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fredericia's QT correction formula.
- A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome).
See the full eligibility criteria
Who can join
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Participants who have undergone treatment with anti-PD-1, anti-PDL1, or anti CTLA 4 antibody must have at least 4 weeks from the last dose of antibody and evidence of disease progression per investigator assessment before enrollment
- Part 3 HNSCC 1. Histologically confirmed squamous cell cancers, regardless of HPV or PD-L1 status. 2. Known HPV (for example, p16 IHC) status. 3. Participants must have received no more than 1 prior line of chemotherapy-based treatment for locally advanced, unresectable, recurrent or metastatic disease. a. Cetuximab is not considered chemotherapy in this protocol
- Part 3 Other HPV-Associated Tumor Types 1. Histologically confirmed anal, vulvar, cervical, penile or vaginal cancers. 2. Known HPV (for example, p16 IHC) status. 3. Participants must have received no more than 1 prior line of therapy (treatment regimen) for locally advanced, unresectable, recurrent or metastatic disease
- Part 3 Neoadjuvant Melanoma 1. Histologically or cytologically confirmed diagnosis of cutaneous melanoma belonging to one of the AJCC TNM stages. 2. No prior radiotherapy or systemic anticancer therapy for melanoma. 3. At least one measurable lesion per RECIST v1.1 that is ≥15 mm in the longest diameter at time of selection.
- Part 3 Neoadjuvant Cutaneous Squamous Cell Carcinoma 1. Histologically or cytologically confirmed locally advanced (high-risk) cutaneous squamous cell carcinoma as defined as: NOTE: Patients are eligible for this trial either at initial presentation for cSCC with locally advanced and/or concurrent regional nodal metastasis, assuming the criteria are met per the cSCC-specific AJCC UICC 8th edition staging classification. 2. At least one lesion measurable per RECIST v1.1 that is ≥15 mm in the longest diameter at time of selection
- Participants who have previously received an immune checkpoint inhibitor prior to enrollment must have any immune related toxicities resolved to ≤Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible
- Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception
- Participants must have histologically confirmed locally advanced, recurrent or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of participants enrolling to the neoadjuvant cohorts
- Participants must have progressed on or be intolerant of available SOC treatment options or have disease for which there is no SOC treatment available, with the exception of participants enrolling to the neoadjuvant cohorts
- At least 2 lesions of measurable disease, unless specified otherwise in the selection criteria.
- Willingness to undergo biopsies
- Demonstrated adequate organ function within 28 days of Cycle 1 Day 1 (C1D1)
- Life expectancy >12 weeks as determined by the Investigator
What rules you out
- Participants who have been previously treated with a TLR agonist (excluding topical agents for unrelated disease) are not eligible.
- Any uncontrolled bacterial, fungal, viral, or other infection.
- Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of first dosing on study is not allowed.
- Significant cardiac disease.
- A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated demonstration of a QTc interval >480 ms (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fredericia's QT correction formula.
- A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval within 14 days of enrollment.
- Positive for HIV or with active hepatitis B or C infection.
- Part 3 Neoadjuvant Melanoma 1. Disease that is deemed unresectable is excluded. 2. Participants with acral/lentiginous, mucosal, or uveal melanoma are excluded.
- Part 3 Neoadjuvant Cutaneous Squamous Cell Carcinoma 1. Patients whose tumor burden, or pace of tumor growth, in the opinion of the Principal Investigator will not permit delaying surgery. 2. Previous solid organ transplantation or bone marrow transplantation.
- Other active malignancies within the last 2 years are excluded.
- Active autoimmune diseases, regardless of need for immunosuppressive treatment at the time of screening, with the exception of patients well controlled on physiologic endocrine replacement.
- Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation). Participants cannot start dosing on study until steroid dose is at or lower than 10 mg per day prednisone or equivalent.
- Women who are breastfeeding or have a positive serum pregnancy test during screening or within 72 hours prior to C1D1 are not eligible.
- Vaccination with live, attenuated vaccines within 4 weeks of enrollment.
- Symptomatic central nervous system metastases.
- Known bleeding disorder that is deemed to place the patient at unacceptable risk for bleeding complications from intratumoral injections or biopsies.
- Known hypersensitivity to any component of TransCon TLR7/8 Agonist or pembrolizumab.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United States
- Taiwan
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United States; Taiwan; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.