Anal Cancer

Researchers are evaluating the safety and effectiveness of Papillex4, a dietary supplement, in women diagnosed with cervical intraepithelial neoplasia CIN grades 1 or 2 caused by HPV infection. The study aims to determine whether Papillex4 leads to regression of abnormal cervical cells compared to a placebo over a 180-day period. This randomized, triple-blind, placebo-controlled trial focuses on cervical cell changes confirmed by histology or cytology. Participants will take either Papillex4 or a placebo, each given as two capsules twice daily with food, one dose with the first meal and one with the last meal. The supplement contains various vitamins and natural extracts. The treatment period lasts 180 days, during which participants also complete questionnaires and undergo tests including a PAP smear, HPV testing, and colonoscopy if applicable. Throughout the study, participants are asked to maintain their usual lifestyle habits and attend clinic visits for sample collection and assessments. Researchers will monitor changes in cervical cell status, HPV clearance, immune markers, micronutrient levels, symptom scores, and quality of life measures up to 360 days. Safety is assessed by tracking adverse events during and after the treatment period, with study completion expected by December 2026.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of HS-20110 combination therapies in patients with advanced colorectal cancer. This multicenter, open-label Phase IbII study uses a Rolling 6 design for dose escalation in Phase Ib, followed by Phase II to further assess these treatments in patients with metastatic colorectal cancer mCRC. The study includes three treatment groups receiving different HS-20110 combinations one with Bevacizumab and 5-FUleucovorin every two weeks, another with Bevacizumab, Oxaliplatin, and 5-FUleucovorin every two weeks, and a third with Bevacizumab, Oxaliplatin, and Capecitabine every three weeks. The treatments are given via intravenous infusion in cycles, with doses adjusted during the study. Participants will be monitored for safety, side effects, drug levels, and response to treatment. Assessments include tumor response using RECIST v1.1 criteria, adverse events, antibody formation against HS-20110, and survival outcomes. Monitoring continues from the first dose until up to three years after the last dose. The study aims to determine the best dose and evaluate the impact on disease control and patient survival over time.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus HPV vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccines ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia CIN and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of EVOLVE104 in adults with advanced or metastatic urothelial and squamous cell carcinomas who have progressed after or cannot undergo standard treatments. This first-in-human Phase 1a1b study includes participants with various advanced solid tumors such as bladder, lung, esophageal, tongue, skin, and anogenital squamous cell carcinomas. The study aims to determine safe dosage levels and gather early data on treatment effects and safety. Participants receive EVOLVE104 as an intravenous infusion in a dose-escalation Phase 1a stage followed by a dose-expansion Phase 1b stage, where dosing for expansion cohorts is based on earlier findings. Treatment continues until disease progression, unacceptable side effects, participant or investigator decision, withdrawal of consent, or death. The expected treatment duration averages about 10 months depending on individual progression. During the study, participants will have regular safety and pharmacokinetic assessments including blood tests, tumor imaging by CT or MRI, and biopsies. Researchers will monitor for treatment-related adverse events, dose-limiting toxicities, and drug levels in the body during 28-day cycles. Effectiveness is also evaluated throughout treatment. Participants must agree to use contraception during and for 120 days after treatment. The total participation time aligns with treatment duration and follow-up for safety and efficacy assessments.

Researchers are evaluating the effectiveness of FOLFIRI chemotherapy with or without Bevacizumab compared to Irinotecan CPT-11 with or without Bevacizumab as a second-line treatment for patients with metastatic colorectal cancer. This Phase III study aims to determine whether overall survival with FOLFIRI is not worse than with Irinotecan. Key goals include assessing progression-free survival, overall survival, time to treatment failure, response rates, disease control, and safety. The study involves two experimental treatment groups. One group receives Bevacizumab intravenously on day 1 of a two-week cycle, combined with CPT-11, l-LV or dl-LV, and 5-FU given as both a bolus and continuous infusion over 46 hours. The other group receives Bevacizumab with CPT-11 only, also on day 1 of a two-week cycle. These infusions are repeated every two weeks during the treatment period. Participants will undergo regular monitoring including assessments of tumor progression and response at scheduled intervals, laboratory tests to check organ function, and recording of any adverse events up to 24 weeks. The primary outcome, progression-free survival, is tracked until 1.5 years after the last patient is enrolled. Secondary outcomes such as overall survival and time to treatment failure are also measured during this period. This study requires informed consent and includes safety follow-up to ensure participant well-being throughout the trial.

Researchers are evaluating a urine test called the 3-metabolite biosensor to detect colorectal cancer CRC and precancerous polyps in adults living in Ghana, Tanzania, and South Africa. The study focuses on participants who either have symptoms of colorectal cancer, are undergoing screening colonoscopy, or have had recent colonoscopy or pathology results related to CRC or polyps. Participants will be observed using the 3-metabolite biosensor, which is designed to identify colorectal cancer and precancerous polyps from urine samples. The study includes individuals with various colonoscopy findings, including those with diagnosed CRC, adenomatous polyps, or no malignancy, and those presenting symptoms such as rectal bleeding. During the study, participants will provide urine samples for testing with the biosensor. Researchers will measure the sensitivity of the biosensor in detecting colorectal cancer and precancerous polyps over up to one year. Participants are asked to be willing to participate and meet the age criteria of 18 years or older. The study is observational and does not involve treatment interventions.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early antitumor effects of IDP-001 in adults with advanced or metastatic squamous and non-squamous non-small cell lung cancer and other squamous cell solid tumors such as head and neck, esophageal, cervical, and cutaneous cancers. This is a Phase 12 open-label study focused on these advanced cancers where standard treatments are limited or no longer effective. Participants will receive IDP-001 as an intravenous infusion. The study includes two parts Phase 1 Part 1 involves dose escalation to determine safety and tolerability over 3-week cycles, while Phase 1 Part 2 focuses on indication selection, evaluating response rates and duration over approximately 6 months. The study is non-randomized and open-label, with all participants receiving the investigational drug. During the study, participants will undergo tumor biopsies and regular assessments including imaging to measure tumor response using RECIST criteria. Safety monitoring includes tracking adverse events and dose modifications. Pharmacokinetic measurements and antibody levels against the drug will be collected. The study duration varies but includes up to 6 months of treatment evaluation and longer-term follow-up for survival outcomes up to 18 months.

This research aims to study the immune response to the nonavalent HPV 9vHPV vaccine in women living with HIV WLWH, a group particularly vulnerable to HPV and cervical cancer. There is limited data on reduced-dose schedules of the 9vHPV vaccine in this population, which is important as the previously used quadrivalent HPV vaccine has been discontinued. The study seeks to inform global strategies for cervical cancer elimination by evaluating different dosing schedules in WLWH aged 18 to 45 years. Participants will be randomly assigned to one of two groups one group will receive three doses of the 9vHPV vaccine following the routine schedule at 0, 2, and 6 months, while the other group will receive two doses at 0 and 6 months, with a third dose at month 12. This design follows current recommendations and allows comparison of immune responses between the routine and extended dosing schedules. During the two-year follow-up, participants will undergo regular assessments to measure immune responses, specifically anti-HPV1618 antibody levels at months 7 and 24. Researchers will also evaluate vaccine safety, effectiveness, and attitudes toward self-collected HPV samples. Surveys will assess vaccine acceptability and comfort. The study includes monitoring for adverse events and aims to provide data to improve HPV vaccination programs for WLWH globally.

Researchers are evaluating whether using lower doses of radiation can reduce side effects when combined with standard chemotherapy in people with HPV-positive throat cancer. This Phase 2 study focuses on patients with hypoxia negative human papilloma virus HPV associated oropharyngeal carcinoma, aiming to improve treatment tolerability while maintaining effectiveness. Chemotherapy drugs involved include cisplatin, carboplatin, 5-fluorouracil 5-FU, paclitaxel, and Abraxane albumin-bound paclitaxel. Participants are assigned to one of four cohorts based on their specific clinical characteristics. Treatments include radiation over three weeks with a total dose of 30 Gy in 2 Gy fractions, combined with chemotherapy regimens varying by cohort. For example, Cohort B receives carboplatin and paclitaxel starting the same week as radiation Cohort C includes induction chemotherapy before radiation and Cohort D focuses on early-stage cases. The study also uses 18F-FMISO PETCT scans for diagnostic imaging before and during treatment to guide therapy. During the study, participants undergo regular assessments including imaging scans, blood tests to evaluate blood counts and organ function, and clinical evaluations to monitor disease status and side effects. Researchers will measure the number of participants experiencing locoregional cancer recurrence over 2 years. Participants must provide informed consent and comply with study procedures, including MRI scans unless contraindicated. The total participation duration varies depending on treatment and follow-up schedules.

Researchers are evaluating SPX-303, a bispecific antibody targeting LILRB2 and PD-L1, in patients with advanced solid tumors who have progressed after prior treatments and are not eligible or decline other options. This open-label Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SPX-303, including identifying the maximum tolerated dose or maximum administered dose. The study consists of two parts Part 1 is a dose escalation and safety expansion phase where SPX-303 is given intravenously every 3 weeks to patients with measurable disease. Part 2 focuses on dose expansion in specific solid tumor types using the recommended Phase 2 dose established in Part 1 to further evaluate anti-tumor activity. Both parts involve close monitoring of treatment effects and side effects. Participants will undergo regular visits for assessments including monitoring for dose-limiting toxicities, adverse events, response rates, disease control, progression-free survival, and drug levels in the body. Safety evaluations will continue for several years, with treatment-related adverse events tracked for up to 3.5 years. The study duration and follow-up periods vary by participant and study phase.