General Practices Across Tayside, United Kingdom
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
This is an open-label, multicenter, first in human (FIH) Phase 1a/1b study of QXL138AM in participants with locally advanced unresectable and/or metastatic solid tumors and multiple myeloma. This study will be conducted in two parts (A and B) and each part has two sub-parts for tumor type (1 and 2). Part A1 - Dose Escalation in Solid Tumors The following solid tumor types will initially be enrolled in this part: ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal, lung, prostate, and breast cancer. Dose escalation will use a standard 3+3 design, where 3 to 6 participants with advanced solid tumors will be enrolled sequentially into each cohort/dose level with the exception of Cohort 1 and 2. For Cohorts 1 and 2, given the very low starting dose, only one participant is planned for each level unless a participant experiences a Grade 2 or higher adverse event not clearly and incontrovertibly related to disease progression or an extraneous factor. If such a Grade 2 or higher event occurs in Cohort 1 or 2, dose escalation will switch to a standard 3+3 design. Dose escalation will continue until the MTD or RDE is determined in participants with solid tumors, referred to as the RDE-ST. At this point, the two solid tumor types for dose expansion will be selected for Part B1 and may begin at the RDE-ST. The proposed dose levels are defined in the table below. Cohort No. of Participants Dose Level (Q2W) (mg/kg) 1. 1-6 0.001 2. 1-6 0.003 3. 3-6 0.01 4. 3-6 0.03 5. 3-6 0.1 6. 3-6 0.3 7. 3-6 1 8. 3-6 2 9. 3-6 4 Infusions will be administered via syringe pump or IV bag (depending on the dose) and administered over a 30-60-minute (± 10 minutes) duration. Part A2 - Dose Escalation in Multiple Myeloma Dose escalation in multiple myeloma will commence when the RDE-ST for solid tumors has been identified, or if there are signs of anti-tumor activity in Part A1 as determined by the Sponsor. Dose escalation will use a standard 3+3 design, where 3 to 6 participants with multiple myeloma will be enrolled sequentially into dose escalation cohorts starting at one dose level below the RDE-ST determined from solid tumor dose escalation (RDE-ST-1). Alternatively, if signs of anti-tumor activity in Part A1 are observed, the Sponsor may elect to initiate dose escalation in multiple myeloma at one dose level below the highest dose already deemed safe in Part A1. If two of the first six participants in the first multiple myeloma cohort experience a DLT, then the dose will be further reduced by one level (RDE-ST-2). Once the RDE for multiple myeloma patients is determined, it will be referred to as the RDE-MM and dose expansion may begin in patients with multiple myeloma at this dose. Part B1: Dose Expansion in Solid Tumors When the RDE-ST has been identified by the SRC from Part A1, the study may continue to Part B1 dose expansion to further explore the safety and anti-tumor activity of QXL138AM in solid tumors. Dose expansion will enroll two cohorts of 20 participants each in two solid tumor indications identified from Part A1. In each cohort, patients will be randomized 1:1 to receive the RDE-ST dose or 1 dose lower. The Sponsor may opt to enroll additional participants up to a maximum of 40 in each cohort if signs of anti-tumor activity are observed. Part B2: Dose Expansion in Multiple Myeloma When the RDE-MM in multiple myeloma has been identified by the SRC from Part A2, the study may continue to Part B2 dose expansion to further explore the safety and anti-tumor activity of QXL138AM in patients with multiple myeloma. Up to 20 participants will be treated at the RDE-MM identified in Part A2. Patients will be randomized 1:1 to receive the RDE-MM dose or 1 dose lower.
Phase
1Span
196 weeksSponsor
Nammi Therapeutics IncNew York, New York
Recruiting
Shirley, New York
Recruiting
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Phase
3Span
387 weeksSponsor
GlaxoSmithKlineShirley, New York
Recruiting
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias
Phase
1/2Span
231 weeksSponsor
Alpine Immune Sciences, Inc.Shirley, New York
Recruiting
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
A trial to learn if durvalumab plus tremelimumab with chemotherapy is safe and how well it works compared to pembrolizumab with chemotherapy in participants with metastatic non-small cell lung cancer with certain genetic mutations. INFORMATION FOR TRIAL PARTICIPANTS: Researchers are looking for a better way to treat people who have metastatic NSCLC and tumors with STK11, KEAP1, or KRAS genetic mutations. Most people learn they have NSCLC after it has already become metastatic, and it can no longer be treated with surgery. Based on previous trials, researchers think durvalumab plus tremelimumab with chemotherapy could help participants more than the current standard treatment, which is pembrolizumab with chemotherapy. Durvalumab and tremelimumab are designed to work by helping the immune system recognize and kill cancer cells. In this trial, researchers want to learn more about how well durvalumab plus tremelimumab with chemotherapy works in people with metastatic NSCLC and genetic mutations that can cause the cancer to be less responsive to treatment. This trial is planned to have 280 participants. These participants will be randomly divided into one of two groups: - One group will receive durvalumab plus tremelimumab with standard of care chemotherapy - One group will receive pembrolizumab with standard of care chemotherapy Durvalumab, tremelimumab, pembrolizumab, and chemotherapy are given as an injection over time into a vein, also called an IV infusion. Chemotherapy will be one of the following regimens: pemetrexed plus cisplatin or pemetrexed plus carboplatin. This is an open-label trial. This means that each participant will know which trial treatment they receive, and the doctors and trial staff will also know. Researchers will measure and compare: - How long participants live during the trial - How long participants live during the trial without their cancer getting worse - How many participants' tumors respond to treatment - How long participants' tumor responses last - How long before participants need to start a different treatment type Researchers will also keep track of all the medical problems participants have during the trial and monitor their safety. Participants will stop receiving trial treatment if they no longer benefit from it or they stop participating for another reason. Participants will visit their trial site every 3 to 4 weeks. At most visits, participants will: - Have a physical exam and answer questions about any medications they are taking or any medical problems they have - Receive their trial treatment - Give blood and urine samples - Have pictures of their tumors taken using CT or MRI scans
Phase
3Span
363 weeksSponsor
AstraZenecaShirley, New York
Recruiting
Study of INCB123667 in Subjects With Advanced Solid Tumors
Phase
1Span
213 weeksSponsor
Incyte CorporationShirley, New York
Recruiting
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.
Phase
1/2Span
300 weeksSponsor
DualityBio Inc.Shirley, New York
Recruiting
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
Phase
2Span
297 weeksSponsor
Ambrx, Inc.Shirley, New York
Recruiting
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Phase
3Span
455 weeksSponsor
Gilead SciencesShirley, New York
Recruiting
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform
Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond. Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies. In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for ICIs like PDL1, MSI, and TMB.
Phase
N/ASpan
205 weeksSponsor
ElephasShirley, New York
Recruiting