Clinical Trials for Squamous Cell Carcinoma Of The Skin

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select 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.

TrialFetch AI summary: Adults with select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies

Active drug

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

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.

TrialFetch AI summary: Transplant recipients (solid-organ or hematopoietic cell) with recurrent, locally advanced, or metastatic cutaneous malignancies confined to skin/soft tissue/lymph nodes and with measurable injectable disease receive intratumoral RP1. RP1 is a modified HSV-1 oncolytic immunotherapy (ICP34.5/ICP47-deleted; expresses GM‑CSF and fusogenic GALV‑GP R‑) given every 2 weeks to induce tumor-selective lysis and antitumor immunity; patients with visceral/CNS metastases, recent rejection, active HSV, or uncontrolled viral infections are excluded.

ClinicalTrials.gov ID: NCT04349436

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

Active drug

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

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.

TrialFetch AI summary: This trial enrolls adult patients with advanced solid tumors, including NSCLC, who have progressed after anti-PD-1/PD-L1 therapy to evaluate MEM-288, an oncolytic adenovirus with immunostimulatory properties, alone and in combination with the PD-1 inhibitor nivolumab.

ClinicalTrials.gov ID: NCT05076760

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

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.

TrialFetch 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 Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

Active drug

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

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.

TrialFetch AI summary: This trial enrolls adults with metastatic or unresectable, PD-L1–expressing solid tumors (including NSCLC, HNSCC, esophageal SCC, TNBC, ovarian cancer, melanoma, and gastric cancer) who have failed or are ineligible for standard therapies. Patients receive either SGN-PDL1V, an antibody-drug conjugate targeting PD-L1 and delivering MMAE, or a combination of SGN-PDL1V plus pembrolizumab.

ClinicalTrials.gov ID: NCT05208762

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

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.

TrialFetch 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

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.

TrialFetch 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

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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