Solid Tumor Cancer

Pediatric malignant solid tumors (including neuroblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, and germ cell tumors) account for approximately 60% of childhood malignancies. Despite multimodal therapy, children with relapsed or refractory disease have poor outcomes. Repeated lines of intensive salvage chemotherapy cause cumulative damage to the hematopoietic system, resulting in profound and prolonged myelosuppression (absolute neutrophil count \<0.5×10\^9/L or platelet count \<20×10\^9/L) that often fails to recover despite standard supportive care with short-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF) and recombinant human thrombopoietin (rhTPO). This leads to chemotherapy delays that compromise treatment continuity and intensity. Umbilical cord blood (UCB) contains hematopoietic progenitor cells, NK cells, T lymphocytes, and various hematopoietic and immunomodulatory factors. UCB infusion has been shown to accelerate hematopoietic recovery after chemotherapy and may enhance anti-tumor immune function. This is a single-center, single-arm, prospective exploratory study. Approximately 10 children (aged 1-18 years) with relapsed or refractory malignant solid tumors who develop severe post-chemotherapy myelosuppression with delayed hematopoietic recovery (persistent ANC \<1.0×10\^9/L and platelets \<50×10\^9/L despite ≥7 days of rhG-CSF/rhTPO support, resulting in chemotherapy delay) will receive UCB infusion in addition to continuing background anti-tumor therapy and standardized hematopoietic supportive care. Each patient may receive up to 3 UCB infusions. The follow-up period is 12 weeks from the first infusion. The study aims to: (1) evaluate the effect of UCB infusion on promoting hematopoietic recovery and on-schedule chemotherapy completion (compared with institutional historical controls); (2) evaluate immune reconstitution after UCB infusion, including dynamics of T-lymphocyte subsets, NK cells, B cells, and serum cytokines; (3) assess the safety of UCB infusion; and (4) explore differences in hematopoietic recovery and immune reconstitution across tumor types and treatment backgrounds.

This pilot randomized study will evaluate whether adding a brief, structured multidimensional risk-recognition tool to standard multidisciplinary assessment can improve treatment planning for adults who are about to start first-line systemic anticancer treatment for a solid tumor. Before systemic anticancer treatment begins, patients may have medical, symptom-related, nutritional, psychological, social, or functional problems that can affect treatment safety, feasibility, and continuity. In routine multidisciplinary care, these issues are usually assessed by different health care professionals using discipline-specific approaches. However, risks identified in different areas may not always be considered together in a standardized way. Participants will be randomly assigned to one of two groups. Both groups will receive the institution's standard multidisciplinary pre-treatment assessment and usual clinical care. In the intervention group, health care professionals will additionally complete the Common Multidimensional Assessment Tool (CMAT), which evaluates six areas: oncological/medical feasibility, symptom burden, nutritional risk, psychological risk, social risk, and functional/geriatric risk. Predefined criteria will be used to identify situations that require additional multidisciplinary discussion before the final treatment plan is documented. The main outcome of the study is whether the final treatment plan differs in a clinically meaningful way from the provisional treatment plan recorded before multidisciplinary assessment. Such changes may include modifications to the anticancer treatment regimen, dose, treatment timing, frequency or route, as well as the addition of supportive, nutritional, psychological, social, or geriatric interventions. The study will also evaluate whether the CMAT-supported approach is feasible and acceptable in routine clinical practice, how consistently different professionals identify patient risks, and whether the approach is associated with differences in early treatment-related outcomes such as severe toxicity, treatment delays or dose modifications, emergency department visits, hospital admissions, treatment discontinuation, and adherence problems. Approximately 60 participants will be enrolled, with about 30 participants in each study group. As a pilot study, the trial is intended primarily to assess feasibility, implementation, and preliminary effect estimates to inform the design of a future larger multicenter study.

The goal of this clinical trial is to learn whether changing the diet can help improve gut health and support recovery from immune-related side effects caused by immune checkpoint inhibitor (ICI) cancer treatment in adults with solid tumors who develop moderate to severe immune-related side effects that require steroid treatment. The main questions it aims to answer are: Does a high-fermented food diet or a high-fiber resistant starch supplement change the gut microbiome (the bacteria and other microorganisms that live in the digestive tract) during treatment? Does either dietary approach improve gut microbiome diversity and function by the end of the 7-week intervention period? Researchers will compare participants assigned to a high-fermented food diet with participants assigned to high-fiber resistant starch supplementation to see if one approach leads to greater improvements in the gut microbiome and related biological measures. Participants will: Be randomly assigned to 1 of 2 dietary intervention groups: High-fermented food diet High-fiber resistant starch supplement Follow their assigned diet for 7 weeks, starting when their ICI treatment is restarted. Provide stool samples before the intervention begins and regularly throughout the study. Have blood samples collected at the start of the study and approximately every 3 to 4 weeks during participation. Provide skin and mouth swab samples at the beginning of the study and again at Week 7. Complete food diaries and symptom assessments during the study. Participate in a 2-week follow-up period after completing the dietary intervention. Researchers will also evaluate the safety of the dietary interventions, whether immune-related side effects return, how the immune system responds, and how closely participants follow their assigned diet.

This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.

Use of samples from patients with solid cancer tumour diagnosis to assess chemistry

This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.

This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

This study aims to develop, train, and validate a machine learning-based prediction model (PROTEGER) to provide treatment decision recommendations for older adults diagnosed with solid tumor cancers. The study has a two-phase observational design: a retrospective cohort using anonymized data from an oncogeriatric telecommittee to train the predictive model, followed by a prospective multicenter cohort across Chile, Peru, and Brazil. Information from Comprehensive Geriatric Assessments (CGA), treatment decisions, and 3- and 6-month clinical outcomes will be collected to evaluate and validate the decision-support platform's performance in assisting oncology teams.

It is recommended that cancer centers screen patients for distress and refer them to mental health services when their distress levels reach a certain level. However, many cancer centers don't have distress screening and referral programs. This study will provide valuable information about one distress screening and referral program and whether it can be helpful for a large and diverse group of cancer patients that includes both English- and Spanish-speaking patients.

The goal of this clinical trial is to: * In Phase 1 (observational) to develop an algorithm for treatment of Duffy-null positive patients for chemotherapy dosing * In Phase 2 (interventional), use the algorithm created in phase 1 to adjust chemotherapy dosing for Duffy-null patients

This is a Phase I, multicenter, single-arm, open-label clinical study designed to evaluate the safety and tolerability of JL19001 Injection as monotherapy (Phase Ia) or in combination with standard therapy (Phase Ib) in patients with AST and r/r B-NHL. Only the Phase Ia protocol design is registered at this time. A total of 6 dose cohorts are planned for Phase Ia, i.e., 1, 5, 10, 15, 20, and 25 μg/kg, with the administration route being subcutaneous injection. A traditional 3 + 3 dose escalation design will be used. The MTD and Recommended Maximum Add-on Dose (RMAD) for JL19001 Injection will be determined.

This study entails enrolling participants that have been diagnosed with cancer to Olivia, a commercially available AI-enabled personal health platform developed by Tempus. Olivia will serve as the primary interface for eConsent and enrollment into the registry. The platform will also help create a retrospective and prospective registry by working with over 1,000 healthcare systems to combine electronic health records (EHR) and Patient Reported Outcomes (PROs) in a single spot. There may be sub-studies as an add-on to this parent protocol. The sub-studies will address specific goals of the targeted research activities and will usually include additional information specific to each research study.

The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC). A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.

The goal of this phase 1 clinical trial is to evaluate the safety, tolerability, and preliminary antitumor activity of a peptide-delivered IL-22BP biotherapy in patients with advanced solid tumors. The main questions it aims to answer are: Is the IL-22BP formulation safe and tolerable? Does the IL-22BP formulation show preliminary antitumor activity?

Purpose: This study is developing and validating an artificial intelligence (AI)-driven system to evaluate tumor response using changes in total tumor volume. The goal is to determine whether this AI-based approach can better predict patient survival compared with the current standard method (RECIST), which relies on linear measurements of a few selected tumors. Participants: The study includes both retrospective and prospective cohorts. The retrospective cohort includes approximately 6,000 patients with solid tumors who received non-surgical treatment between 2015 and 2025. The prospective cohort will enroll approximately 120 patients starting in mid-2026. Study details include: Study Duration: Approximately 3 years Participation Duration: Up to 6 months for prospective participants; retrospective participants contribute existing medical records only Visit Frequency: For prospective participants, follow-up visits occur every 3 months (up to 6 months) aligned with routine clinical care Intervention: None. This is an observational study using routine clinical imaging (CT/MRI) and medical records Primary endpoints: Overall survival (OS) and progression-free survival (PFS). The study will also evaluate the feasibility and impact of AI-assisted tumor response reporting on clinical workflow and patient understanding. Participants in the prospective cohort will receive either a standard RECIST report or an AI-assisted dynamic tumor response report. This comparison is for research purposes only and does not alter standard medical care.

The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer. The main questions it aims to answer are: What adverse events and toxicities (harmful side effects) are associated with different doses of PLT012? What are the blood levels of PLT012 in your body at different timepoints? What effect does PLT012 have on reducing tumor size and/or preventing the worsening of cancer? All participants will receive PLT012 and none will receive placebo (a look-alike substance that contains no drug). Participants will receive PLT012 by intravenous infusion once every 3 weeks. Treatment with PLT012 can continue until the participant's disease worsens or they cannot tolerate treatment. For the first 12 weeks, visits to the clinic will be more frequent (from 1 to 5 times over a 3-week period). After the first 12 weeks, visits will be reduced to once every 3 weeks.

This is an open label phase II study using metronomic low-dose gemcitabine and mitomycin c given intravenously, and thalidomide administered orally, for patients with advanced solid tumors.

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.

This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor

This study evaluates a non-cationic peptide-CD47 siRNA nanocomplex for refractory advanced solid tumors. The candidate blocks the CD47-SIRPα "don't eat me" signal, repolarizes tumor-associated macrophages, and restores antitumor immunity. Using a 3+3 dose-escalation design (25, 50, 100 μg), the investigators aim to define the MTD and RP2D, providing a novel therapeutic approach and clinical evidence for siRNA drug development.

The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works. Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment. * Have safety follow-up (SFU), and long-term follow-up. * Be followed until progression.

This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.

This is a multicenter, open-label, Phase Ib/II clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.

Earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. This project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor DNA (ctDNA) molecular residual disease (MRD) detection timepoint. Ultimately, the integration of ctDNA into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.