Clinical Trials for Squamous Cell Carcinoma Of The Skin

Phase 2 Study of Afatinib in Advanced 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.

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: Single-arm study of afatinib 40 mg PO daily in adults with unresectable locally advanced or metastatic cutaneous SCC, requiring prior anti–PD‑1/PD‑L1 therapy if eligible; includes immunosuppressed and transplant recipients, and allows treated/stable brain metastases. Afatinib is an irreversible ErbB (EGFR/HER2/HER4) inhibitor; treatment continues until progression/toxicity with imaging every 8 weeks.

ClinicalTrials.gov ID: NCT05070403

A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Adults with unresectable stage III/IV solid tumors (e.g., melanoma, BCC, SCC) refractory to prior anti–PD‑1/PD‑L1 therapy receive an oral, precision‑engineered live biotherapeutic (R‑5780) added to their ongoing PD‑1 pathway inhibitor. R‑5780 is designed to modulate gut–immune pathways to enhance anti‑tumor T‑cell responses and potentiate checkpoint inhibition; key exclusions include recent broad‑spectrum antibiotics, active infections, significant autoimmune disease, untreated brain mets, and >4 prior systemic therapies.

ClinicalTrials.gov ID: NCT06398418

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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.

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.

HealthScout AI summary: This trial involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: The trial is for adult patients with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma who have no remaining standard treatment options, and it evaluates the safety, tolerability, and dosing of the investigational drug LB-LR1109, administered intravenously.

ClinicalTrials.gov ID: NCT06332755

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This trial enrolls adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express EGFR and have lost HLA-A*02 expression, including types such as CRC, NSCLC, HNSCC, TNBC, and RCC, and tests A2B395, a logic-gated Tmod™ CAR T-cell therapy designed to selectively target these tumor cells while sparing healthy cells. Participants receive a preconditioning lymphodepletion regimen followed by a single intravenous dose of A2B395.

ClinicalTrials.gov ID: NCT06682793

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with locally advanced or metastatic solid tumors harboring oncogene amplifications who have progressed on or are ineligible for standard therapies may receive oral BBI-355, a selective CHK1 inhibitor, either as monotherapy or combined with erlotinib (EGFR inhibitor) or futibatinib (FGFR inhibitor) in cohorts defined by specific gene amplifications. Key exclusions include certain oncogenic mutations, prior targeted therapies, CNS involvement, and serious comorbidities.

ClinicalTrials.gov ID: NCT05827614

A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients with Advanced Solid Tumors or Lymphomas

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors or designated lymphomas (with confirmed CD161 expression) who have failed or are intolerant to standard therapies, to receive the investigational anti-CD161 monoclonal antibody IMT-009 (which blocks an inhibitory NK/T cell pathway) as monotherapy or in combination with fruquintinib.

ClinicalTrials.gov ID: NCT05565417

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This trial enrolls adults with advanced, recurrent, or metastatic solid tumors (including platinum-resistant ovarian cancer, triple-negative breast cancer, squamous cell carcinoma of the anus or head and neck, non-small cell lung cancer, and uterine serous cancer) who have progressed on all standard therapies, to receive SMP-3124LP, a novel liposomal CHK1 inhibitor given by intravenous infusion. SMP-3124LP targets the DNA damage response pathway and is being assessed for safety, tolerability, and preliminary efficacy.

ClinicalTrials.gov ID: NCT06526819

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This study enrolls adults with unresectable, locally advanced, or metastatic antigen-rich solid tumors—including TMB-H, MSI-H/dMMR, virally associated, metastatic colorectal, triple negative breast, platinum-resistant ovarian, metastatic castration-resistant prostate, and NSCLC—who lack standard treatment options. Patients receive STAR0602 (invikafusp alfa), a bifunctional bispecific antibody that selectively activates and expands Vβ6/Vβ10 T cell subsets to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT05592626

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors who have progressed after standard therapies to receive DB-1310, a HER3-targeting antibody-drug conjugate with a topoisomerase I inhibitor payload, as monotherapy or in combination with trastuzumab (HER2+ breast cancer) or osimertinib (EGFR-mutant NSCLC). Key eligibility includes measurable disease, ECOG 0-1, and no prior HER3-ADC or topoisomerase I inhibitor exposure.

ClinicalTrials.gov ID: NCT05785741