A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers
This study is testing a new cancer treatment called MK-2870 to see if it has few side effects and works well for patients with certain types of gastrointestinal (GI) cancers. Patients will join the study and be placed into one of three groups based on their type of cancer: patients with colorectal cancer (CRC), patients with pancreatic cancer (PDAC), and patients withbiliary tract cancer (BTC). The study will check for side effects and see how well the treatment helps shrink tumors. For the CRC group, the study will first test the safety and side effects of MK-2870 with another drug, a combination of 5-FU (5-fluorouracil) and LV (leucovorin), before moving on to see how well it works. Any side effects will be carefully tracked and reported.
A Phase 1/2a Multicenter Open-Label First in Human Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of DB-1303 in Patients with Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.
A Phase 1/2a Multicenter Open-Label First in Human Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors
This is a multicenter, non-randomized, open-label, multiple-dose, first in human (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 maximum tolerated dose (MTD)/recommended phase 2 dose (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 malignant solid tumors.
A Phase 1a/1b First-in-human Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
This study will test the potential tumor-fighting effects of a daily medication called RGT-61159 for patients with advanced ACC or CRC, two types of cancer, when other treatments have stopped working or aren’t suitable. Patients will take RGT-61159 in 21-day cycles, starting at a dose of 6 mg. The study uses a dose-escalation plan, meaning patients will move to higher doses until the highest safe dose, or recommended Phase 2 dose (RP2D), is found. If certain side effects appear, more patients may be added at the current dose level to carefully check for safety and find the best dose for future studies.
A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors
This study is testing the tolerability, effectiveness, and potential for few side effects of the drug LY3962673 in patients with advanced solid tumors that have a KRAS G12D mutation, like pancreatic, colorectal, and lung cancer. In Phase 1a, the drug will be tested alone to see if it is well-tolerated and has few side effects. Some patients may receive different doses to check for side effects and how the drug works in the body. In Phase 1b, LY3962673 will be tested alone and with other standard treatments to find the best dose for these cancers. A committee will decide on dose increases based on the safety data.
A Phase 1b Study of JNJ-78278343 a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2) in Combination with either JNJ-63723283 (cetrelimab) Taxane Chemotherapy or Androgen Receptor Pathway Inhibitors for Metastatic Castration- Resistant Prostate Cancer
This study will test the early effects of the immunotherapy drug JNJ-78278343, a bispecific antibody targeting KLK2 and CD3, combined with taxane chemotherapy or androgen receptor pathway inhibitor in adults with metastatic castration-resistant prostate cancer (mCRPC) who have already had at least one treatment. The study has two parts: Part 1, which will find the most effective dose by testing different amounts of the drugs in patients and Part 2 will include patients for each dose found to have few or no side effects and effective. A team of experts will watch for any safety issues and can stop the study if needed. The study has a Screening Period before treatment begins, a Treatment Period while the drugs are given, and an End of Treatment (EOT) visit when the treatment stops. Patients will be checked for side effects for up to 100 days after their last dose of cetrelimab or 30 days after their last dose of JNJ-78278343, depending on which comes later.
A Phase 1b Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Nivolumab will be investigated at the Food and Drug Administration (FDA)-approved dose of480 mg intravenous (IV) every 4 weeks until unacceptable toxicity, disease progression, orcompletion of 2 years of therapy. If that dose and schedule have unacceptable toxicity, thenenrollment will cease for that particular disorder/severity group. Depending on accumulatedexperience from this study and other emerging literature, additional doses and schedules may beconsidered.This study is designed to enroll cohorts of up to 12 patients for each disease cohort who will betreated with nivolumab at the standard dose at each disease severity level. For each autoimmunedisorder, patients with different severity of the disease, as defined by disease-specific severityindices, will be assessed.Patients will initially be enrolled into the mild and moderate cohorts (exact designations in Table1). If nivolumab is well tolerated in this study population, then enrollment to more severecohorts will be opened following discussions with Cancer Therapy Evaluation Program(CTEP)/National Cancer Institute (NCI) and study teams at participating sites.
A Phase 1b Study to Evaluate the Safety Tolerability and Preliminary Efficacy of ATP150/ATP152 VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
This is an open-label, phase 1b study comprising two parts (safety and immunogenicity part and randomized efficacy part) to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of a heterologous prime-boost vaccine (protein and viral vector) strategy, in which approximately 90 patients with resected KRAS G12D/G12V mutated pancreatic cancer and colorectal cancer after (neo-) adjuvant chemotherapy or chemoradiotherapy will be enrolled in the following treatment parts of the study:Part 1 (Safety and Immunogenicity Part) – PDAC and CRC patientsPart 2 (Efficacy Part) – PDAC patients only
A PHASE 1B/2 MULTICENTER OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd) A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC) IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE IN SUBJECTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER (ES-SCLC) (IDeate-Lung03)
This global study is designed to test how safe and effective the drug I-DXd is when combined with atezolizumab, with or without carboplatin. The treatment will be used either as ongoing maintenance therapy or as part of a short initial treatment followed by maintenance. The study will take place at multiple locations in the United States, Europe, and Japan. It has two main parts: Part A focuses on checking safety, while Part B adjusts the doses to find the best amount to use. Patients must be able to perform normal daily activities and can join even if they have brain metastases that don’t cause symptoms. A type of radiation therapy called prophylactic cranial irradiation (PCI) is allowed if the patient’s cancer responds well to the treatment. The study will start by testing one group to see if thedoses are safe before adding more groups and eventually randomizing patients. Previous studies suggest that combining I-DXd and atezolizumab should have manageable side effects. Researchers may add new treatment options to the study later if needed.
A Phase 1b/2 Open-label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE)
This is a multicenter, Phase 1b/2 trial. The Phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.