Clinical Trials for Squamous Cell Carcinoma Of The Skin

First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected 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: Adults with advanced or metastatic solid tumors (including NSCLC, triple-negative breast cancer, head and neck squamous cell carcinoma, gastric cancer, or melanoma), particularly those refractory or relapsed after immune checkpoint inhibitors, will receive the investigational anti-CCR8 monoclonal antibody BAY3375968 (which depletes tumor-infiltrating Tregs) as monotherapy or combined with pembrolizumab. Eligible patients must have measurable disease, ECOG 0-1, and be willing to undergo tumor biopsies.

ClinicalTrials.gov ID: NCT05537740

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

An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and/or Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation

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 unresectable, advanced, or metastatic solid tumors (including NSCLC, colorectal, HNSCC, pancreatic, ovarian, or breast cancer) that are both HLA-A*02:01 positive and harbor the TP53 R175H mutation, and who have progressed on prior therapy, may receive NT-175, an autologous T cell product genetically engineered with a TCR targeting TP53 R175H and rendered resistant to TGF-β mediated immunosuppression. Treatment includes leukapheresis, lymphodepletion (fludarabine/cyclophosphamide), NT-175 infusion, and short-course subcutaneous IL-2.

ClinicalTrials.gov ID: NCT05877599

A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants With Antigen-positive Locally Advanced (Unresectable) 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: This trial enrolls adults with unresectable or metastatic solid tumors expressing MAGE-A1, MAGE-A4, MAGE-C2, PRAME, or HPV16 antigens and specified HLA types, who have exhausted standard treatments. Participants receive autologous TCR-engineered T cells (TCR-T) targeting these antigens, as monotherapy or in combination, following lymphodepleting chemotherapy.

ClinicalTrials.gov ID: NCT05973487

A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers

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 selected advanced solid tumors—including NSCLC, renal cell carcinoma, melanoma, platinum-resistant ovarian cancer, nasopharyngeal carcinoma, and triple negative breast cancer—who have progressed after specific prior therapies, to evaluate the safety and dosing of KFA115 (a novel immunomodulatory small molecule, presumed to enhance anti-tumor immunity) as monotherapy and in combination with pembrolizumab. Exclusion criteria include significant cardiac, autoimmune, and interstitial lung diseases, as well as history of severe hypersensitivity to study drugs.

ClinicalTrials.gov ID: NCT05544929

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies

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 advanced unresectable or metastatic melanoma (non-uveal/mucosal), head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer, or classical Hodgkin lymphoma who have progressed on prior PD-1/PD-L1 therapy are eligible to receive CTX-8371, an investigational bispecific antibody targeting PD-1 and PD-L1 designed to overcome checkpoint inhibitor resistance, as monotherapy.

ClinicalTrials.gov ID: NCT06150664

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients 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: Eligible patients have advanced, unresectable, or metastatic solid tumors of multiple types that are refractory to standard therapy and have a tumor accessible for intratumoral injection or biopsy. This trial evaluates the investigational oncolytic immunotherapy VET3-TGI (a vaccinia-derived agent engineered to kill tumor cells and modulate the tumor microenvironment via CXCR3, IL-12, and TGF-β inhibition) given by intratumoral or intravenous administration, alone or with pembrolizumab.

ClinicalTrials.gov ID: NCT06444815

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in 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 unresectable, locally advanced or metastatic solid tumors expressing Nectin-4 who have progressed after or are ineligible for standard systemic therapy, excluding those with brain metastases or serious comorbidities. Patients receive IPH4502, a novel antibody-drug conjugate targeting Nectin-4 with an exatecan payload, administered as monotherapy.

ClinicalTrials.gov ID: NCT06781983

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

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: Enrolling adults with locally advanced or metastatic epithelial cancers (including multiple breast cancer subtypes, NSCLC, cervical, prostate, pancreatic, head and neck, endometrial, ovarian, gastric/GEJ, or urothelial carcinomas) who have progressed after ≥2 prior therapies and lack standard options, this study delivers IV DR-0202, a bispecific antibody targeting CLEC7A on myeloid cells and a tumor-associated antigen, aiming to activate myeloid-driven phagocytosis and antitumor immunity.

ClinicalTrials.gov ID: NCT06999187