Clinical Trials for Squamous Cell Carcinoma Of The Skin

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial involves patients over 18 with advanced solid tumors expressing high levels of EphA2, testing the safety and efficacy of BT5528, a targeted Bicycle Toxin Conjugate linked to MMAE, as a monotherapy and in combination with the PD-1 inhibitor nivolumab, particularly in ovarian, urothelial, lung, breast, head and neck, and gastric cancers after progression on standard treatments.

ClinicalTrials.gov ID: NCT04180371

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors—including specific expansion cohorts for RCC, NSCLC, and PD-L1-negative NSCLC—who have progressed after or cannot tolerate standard therapies or are treatment naïve for metastatic disease without actionable mutations. Patients receive STK-012, an engineered IL-2 partial agonist that selectively stimulates CD25+ T cells with reduced toxicity risk, as monotherapy or in combination with pembrolizumab, and in NSCLC, with pembrolizumab plus pemetrexed and carboplatin.

ClinicalTrials.gov ID: NCT05098132

A Multicenter Phase I/Ib Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic renal cell carcinoma, melanoma, cutaneous squamous cell carcinoma, or PD-L1-positive non-small cell lung cancer who are relapsed/refractory to standard therapy or lack standard options, have ECOG 0/1, and meet organ function criteria; exclusions include prior IL-2, active autoimmune disease, and symptomatic brain metastases requiring steroids. Treatments include WTX-124, a conditionally activated IL-2 prodrug that targets the tumor microenvironment, as monotherapy or in combination with pembrolizumab (anti-PD-1).

ClinicalTrials.gov ID: NCT05479812

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Eligible adult patients have advanced, refractory HER2-positive solid tumors with at least one injectable lesion. The trial evaluates safety and preliminary efficacy of intratumoral CAdVEC, an oncolytic adenovirus expressing IL-12 and a PD-L1 blocker, alone or in combination with intravenous HER2-specific autologous CAR T cells at higher dose levels.

ClinicalTrials.gov ID: NCT03740256

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced EGFR-driven solid tumors, with expansion in squamous histologies (cSCC post/PD-1-ineligible, first-line R/M HNSCC by CPS strata, ICI-naïve SCAC after 1–2 lines, and stage IV squamous NSCLC post 1 line), receive BCA101 (ficerafusp alfa) alone or with pembrolizumab. BCA101 is a bifunctional anti-EGFR/TGF-β “trap” antibody designed to inhibit EGFR and locally neutralize TGF-β1/3; requires measurable disease and mandatory biopsies, excludes prior anti–TGF-β and certain recent anti-EGFR exposure.

ClinicalTrials.gov ID: NCT04429542

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced/metastatic solid tumors requiring at least one injectable lesion (ECOG 0–1) receive intratumoral T3011—an engineered oncolytic HSV‑1 expressing IL‑12 and an anti‑PD‑1 antibody—either as monotherapy in melanoma, HNSCC post‑platinum/PD‑(L)1, sarcoma, or cSCC, or combined with IV pembrolizumab in previously treated metastatic NSCLC without EGFR/ALK alterations. Excludes patients with uninjectable disease, high‑risk injection sites, active autoimmune disease requiring immunosuppression, active HSV, significant cardiopulmonary disease, CNS metastases, or active viral infections.

ClinicalTrials.gov ID: NCT04370587

Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with recurrent/metastatic HNSCC (oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal, or unknown primary) after ≥2 prior systemic lines and amenable to salvage surgery receive an autologous tumor membrane vesicle (TMV) vaccine derived from their resected tumor, alone or combined with pembrolizumab. TMV is a personalized intradermal vaccine presenting native tumor membrane antigens/neoantigens to prime T-cell responses; the combination adds anti–PD-1 checkpoint blockade.

ClinicalTrials.gov ID: NCT06868433

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with platinum-refractory recurrent/metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx), PD-L1 CPS ≥1, ECOG 0–2, and no prior systemic therapy for R/M disease are randomized to pembrolizumab alone vs pembrolizumab plus cetuximab. Pembrolizumab is an anti–PD-1 antibody; cetuximab is an anti-EGFR antibody, with the combination tested to enhance efficacy in this setting.

ClinicalTrials.gov ID: NCT06589804

Phase III Randomized Trial of Immunotherapy With or Without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with oligometastatic HNSCC (≤4 metastatic sites) who have not progressed after 3 cycles of pembrolizumab plus platinum/fluorouracil- or paclitaxel-based chemotherapy are randomized to maintenance pembrolizumab (PD-1 inhibitor) with consolidative radiotherapy to all disease sites versus pembrolizumab alone. Requires measurable disease, ECOG 0–1 at induction (0–2 at randomization), no prior head/neck RT, and no active autoimmune disease needing systemic therapy.

ClinicalTrials.gov ID: NCT05721755

A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with histologically confirmed, nonmetastatic recurrent cutaneous SCC, ECOG 0–2, with a single measurable lesion ≤7 cm not amenable to surgery or standard radiation and after failure of at least first-line therapy, receive intratumoral Alpha DaRT-224 seeds (Ra-224 alpha-emitter brachytherapy) placed for ~2–3 weeks to deliver short-range, high–linear energy transfer radiation for local tumor control. Excludes nodal/distant metastases, T4/perineural spread, mucosal/anogenital SCC, and lesions inaccessible for seed placement.

ClinicalTrials.gov ID: NCT05323253