Shirley

Researchers are evaluating AV-380, an immunoglobulin G1 monoclonal antibody designed to bind human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia. This phase 1B open-label dose escalation study aims to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of AV-380 in cancer patients who have cachexia and elevated GDF-15 levels. Participants have metastatic solid tumors and are actively receiving standard of care chemotherapy. Participants receive AV-380 through intravenous infusion in ascending dose cohorts alongside their standard chemotherapy treatments. The study includes a dose escalation phase where the safety and appropriate dosage of AV-380 are evaluated. This phase allows researchers to monitor the effects of increasing doses of AV-380 over a study period of up to 4 months while patients continue their usual cancer therapies. During the study, participants will undergo assessments including monitoring for adverse events, toxicity, and laboratory abnormalities from enrollment until about 60 days after the last dose. Pharmacokinetic measures such as maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC) will also be evaluated. The total involvement includes regular evaluations to track safety, drug behavior in the body, and immune responses to AV-380.

Researchers are evaluating the safety and tolerability of DB-1303/BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 1/2a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts: an initial dose-escalation phase using an accelerated titration followed by a classic "3+3" design to find the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303/BNT323 by intravenous infusion once every three weeks (Q3W) at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are comparing the effectiveness of a combination treatment including tarlatamab, durvalumab, carboplatin, and etoposide to a similar combination without tarlatamab in people with untreated extensive stage small-cell lung cancer (ES-SCLC). This Phase 3 study aims to see if adding tarlatamab can improve overall survival and progression-free survival in this patient group. The study is sponsored by Amgen and focuses on first-line treatment options for this aggressive cancer stage. Participants are assigned randomly to one of two groups. One group will receive tarlatamab combined with durvalumab, carboplatin, and etoposide for four cycles, followed by maintenance treatment with tarlatamab and durvalumab. The other group receives durvalumab, carboplatin, and etoposide for four cycles, followed by durvalumab alone. All drugs are given through intravenous infusions. The study is open-label, meaning both participants and researchers know which treatment is being given. During the study, participants will be monitored up to approximately 3.5 years for overall survival and progression-free survival through blinded independent central review. Additional outcomes like objective response, disease control, duration of response, and treatment-related side effects will be tracked for up to four years. Blood samples will be taken to measure tarlatamab levels and to check for antibodies against the drug. Safety and treatment effects are carefully recorded throughout the study period.

Researchers are evaluating treatments for participants with KRAS/NRAS and BRAF wild-type colorectal cancer that is recurrent, unresectable, or metastatic. The study compares the length of time participants remain disease-free and overall survival when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. All participants have previously received chemotherapy, and the study is a randomized, open-label phase 3 trial sponsored by Janssen Research & Development, LLC. Participants are assigned to one of two groups. One group receives amivantamab combined with the FOLFIRI chemotherapy regimen, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with FOLFIRI. Treatments are given in 28-day cycles and continue until the disease progresses or other reasons require stopping treatment. During the study, participants undergo regular assessments including imaging to monitor disease status and response to treatment. Researchers measure progression-free survival, overall survival, response rates, duration of response, and quality of life through questionnaires. Safety is monitored by tracking adverse events and laboratory test changes. The primary outcomes are evaluated up to about 2 years for progression-free survival and over 4 years for overall survival, with several secondary outcomes assessed up to the same longer timeframe.

This research aims to compare progression-free survival in adult participants with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. The study evaluates two first-line treatment approaches: amivantamab combined with chemotherapy versus cetuximab combined with chemotherapy. This is a Phase 3 randomized, open-label trial assessing outcomes for this specific cancer type. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles of either mFOLFOX6 (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin) or FOLFIRI (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan hydrochloride). The other group receives cetuximab combined with the same chemotherapy options. Each treatment cycle lasts 28 days, and participants continue treatment until disease progression or other stopping criteria are met. During the study, participants will undergo regular assessments including imaging scans reviewed by a blinded independent committee to measure progression-free survival up to 4 years and 2 months. Additional outcomes such as overall survival, response rates, duration of response, and quality of life will be monitored for up to over 7 years. Safety is tracked through adverse event reporting and laboratory tests. Participants' symptoms and functioning will also be evaluated using quality of life questionnaires throughout the study period.

Researchers are evaluating the antitumor activity of amivantamab combined with lazertinib or with chemotherapy in participants who have common EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 2b open-label study aims to understand how well these combinations work as first-line or second-line treatments for this type of lung cancer. Participants will be assigned to one of two groups: one group will receive amivantamab combined with lazertinib orally in 28-day cycles, and the other group will receive amivantamab combined with platinum-based chemotherapy (carboplatin and pemetrexed) given by intravenous infusion in 21-day cycles. Treatment will continue until disease progression, withdrawal, death, or investigator decision to stop treatment. During the study, participants will undergo regular assessments including monitoring for progression-free survival up to 4 years and 6 months. Additional evaluations include tracking dose changes, adverse events, overall survival, response rates, and time to treatment discontinuation. Safety and clinical outcomes will be closely observed throughout the treatment period and follow-up.

This research aims to assess the safety and effectiveness of Navlimetostat (BMS-986504) taken alone in adults with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) who have a specific genetic change called homozygous MTAP deletion and whose cancer has progressed after previous treatments. The study is a Phase 2, randomized, open-label trial sponsored by Bristol-Myers Squibb. Participants will receive one of two doses of Navlimetostat as oral tablets, taken on specified days. The study compares these two dosing regimens to evaluate their impact on cancer response and progression. The trial includes a treatment period followed by monitoring for outcomes including response rates, disease control, survival, and safety over several years after treatment. During the study, participants will undergo regular assessments such as scans to measure tumor size using RECIST v1.1 criteria, symptom and quality-of-life questionnaires, and monitoring for side effects and adverse events. The main measure is the number of participants achieving an objective tumor response. Follow-up will continue for up to three years after the last dose, with additional evaluations of disease control, survival, and health-related quality of life.

Researchers are studying a drug called sigvotatug vedotin (SGN-B6A) alone and combined with pembrolizumab, with or without chemotherapy, to evaluate its safety and effects in people with advanced solid tumors. The study aims to identify side effects and understand how well the drug works to treat various solid cancers. It is a Phase 1 trial conducted in multiple parts to explore different doses and treatment combinations. The trial includes four parts: Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to assess safety and activity against tumors. Parts C and D examine the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with carboplatin or cisplatin chemotherapy drugs. Participants receive these treatments intravenously, with dosage schedules specific to each drug. During the study, participants will undergo tumor biopsies, imaging scans, and clinical assessments to measure treatment responses and side effects. The research team will monitor adverse events, laboratory results, and specific measures of drug concentration in the blood over up to three years. This long-term follow-up helps researchers understand the drug’s impact and safety over time for participants with various solid tumor types.

This research aims to compare the effectiveness of different drug combinations in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study evaluates zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R2) in FL, and zanubrutinib plus rituximab versus R2 in MZL. The main goal is to measure progression-free survival using imaging criteria assessed by an independent review committee following international lymphoma guidelines. Participants receive treatments according to their lymphoma type and assigned study arm. For FL, one group receives zanubrutinib with obinutuzumab followed by zanubrutinib alone until disease progression or other reasons stop treatment. The comparator group receives lenalidomide plus rituximab. For MZL, one group is treated with zanubrutinib plus rituximab followed by zanubrutinib alone, while the other receives lenalidomide plus rituximab. Zanubrutinib is taken orally daily in cycles, rituximab and obinutuzumab are given intravenously on specific days of 28-day cycles, and lenalidomide is taken orally for 12 cycles. Throughout the study, participants undergo regular imaging scans to measure disease response and progression. Researchers also assess other outcomes such as response duration, overall survival, quality of life, and adverse events over several years. Treatment continues until confirmed progression, unacceptable side effects, withdrawal, or study end. The study provides close monitoring and long-term follow-up to evaluate the treatments' impact on lymphoma control and patient well-being.

Researchers are evaluating the safety and effectiveness of two different drug combinations for people with relapsed or refractory multiple myeloma (RRMM) who have had between one and three prior treatments and prior exposure to lenalidomide. The trial compares mezigdomide combined with bortezomib and dexamethasone (MeziVd) against pomalidomide combined with bortezomib and dexamethasone (PVd). This phase 3 study aims to understand which treatment better controls the disease and improves patient outcomes. Participants are randomly assigned to receive either the MeziVd or PVd treatment. Each drug is given at specified doses on certain days, though exact schedules are not detailed here. The study is open-label, meaning both participants and researchers know which treatment is being given. The trial includes multiple centers and continues over a period that may last up to about five years. During the study, participants will be closely monitored through various assessments including measurements of disease progression and survival. Researchers will track progression-free survival, overall response, duration of response, and quality of life among other outcomes. Safety is assessed by monitoring adverse events throughout the study. Participation involves regular visits for treatment and evaluations, and the study may last several years depending on individual patient progress and follow-up.