First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
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This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors
What are basal cell and squamous cell skin cancer?
Both start in keratinocytes, the main cells of the outer skin, and both are caused mostly by ultraviolet light from the sun and tanning beds, which is why they appear on the face, ears, neck, scalp, and hands of people with light skin, usually after 60. Basal cell carcinoma, the most common cancer of any kind, grows slowly, almost never spreads, and typically looks like a pearly bump, a pink patch, or a sore that bleeds and does not heal. Squamous cell carcinoma looks like a firm red nodule, a scaly patch, or a wart like growth; it can spread if neglected, especially in people whose immune systems are suppressed after a transplant. Melanoma is a different, more dangerous cancer of pigment cells and has its own melanoma clinical trials page.
Treatment is surgery for the vast majority, including Mohs surgery, in which thin layers are removed and checked under the microscope until the margins are clear. For the small share of cancers that are too advanced to remove, medicines now exist: hedgehog pathway inhibitors for basal cell carcinoma since 2012, and immunotherapy for advanced squamous cell carcinoma, with cemiplimab approved in 2018 and a second antibody, cosibelimab, in December 2024. The most interesting trials go in the other direction, testing whether immunotherapy injected directly into an early squamous cell tumor can replace surgery, whether a cheap form of vitamin B3 can prevent new cancers in people who keep getting them, and whether new imaging can diagnose skin cancer without a biopsy. There is still no routine screening program: the US Preventive Services Task Force says evidence is insufficient to recommend for or against full body skin checks in people without symptoms, which is itself a research question.
Types of skin cancer clinical trials
Surgery sparing treatment trials. Immunotherapy injected into early squamous cell tumors and compared with surgery in a Phase 3 study, and drug coated microneedle patches.
Advanced disease trials. Immunotherapy combinations for basal cell and squamous cell cancers that cannot be removed or have spread, including in transplant recipients who cannot take standard immunotherapy.
Prevention trials. Nicotinamide and other agents in people with a history of multiple skin cancers, and sun safety programs for teenagers and families.
Diagnosis and screening studies. Optical imaging and AI tools to tell cancer from benign spots, and studies of who benefits from skin checks.
Supportive care trials. Reducing pain and side effects from surgery and radiation, including large studies of nerve pain medicines during treatment.
Rare skin cancers. Merkel cell carcinoma and other uncommon types, often grouped with squamous cell trials.
New to research? Read how informed consent works.
Who can participate in skin cancer clinical trials?
Treatment trials enroll adults with a biopsy confirmed basal cell or squamous cell carcinoma at the stage the study targets, from a single early tumor suitable for a surgery sparing trial to advanced disease that has spread. Prevention trials usually want people who have had two or more skin cancers in recent years, the group most likely to get another. Screening and imaging studies enroll people with suspicious spots awaiting biopsy, and sometimes healthy volunteers. Sun safety studies enroll families and teenagers with no cancer at all. Many immunotherapy trials exclude people on immune suppressing medicines, while some are designed specifically for transplant recipients. Eligibility always varies by study.
Is skin cancer screening recommended?
Not routinely for people without symptoms: the US Preventive Services Task Force found the evidence insufficient to recommend for or against full body skin checks. People at high risk, with many past skin cancers, a transplant, or fair skin and heavy sun exposure, are usually checked regularly by a dermatologist, and studies of who benefits from screening are ongoing.
How skin cancer is classified, and why it matters for trials
Low risk, early. Small tumors in low risk locations, cured by simple removal. The target of surgery sparing and prevention trials.
High risk, local. Large tumors, those on the face, ears, or lips, recurrent tumors, or those in immunosuppressed people. Treated with Mohs surgery and sometimes radiation; trials test adding medicines.
Locally advanced or metastatic. Rare; tumors that cannot be removed or have spread to lymph nodes or beyond. Treated with hedgehog inhibitors or immunotherapy, and where most drug trials recruit.
Pathology reports name the type and whether it is high risk, and study titles say "early stage," "locally advanced," or "metastatic." That report tells you which studies fit.
How to enroll in a skin cancer clinical trial
Identify your trial. Use the filters and search "basal cell," "squamous cell," or "keratinocyte" as well as "skin cancer." Titles name the type and stage.
Select your preferred location. Enter your city or state. Treatment trials run at dermatology and cancer centers; prevention and sun safety studies often run remotely.
Explore study details. Click "Learn More" for the type and stage required, immune suppression rules, and whether a biopsy is needed.
Complete the health profile. Click "Get started" to begin the 5-step application. Have three things ready: your biopsy result naming the type, how many skin cancers you have had, and whether you take immune suppressing medicines.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.