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A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients with Surgically Resectable Hepatocellular Carcinoma (Morpheus-Neo-HCC)

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05908786

Population:

Adult

Phase:

I/II

The purpose of this study is to compare the effects, good or bad, of the cancer immunotherapy (CIT) combinations on you and your liver cancer, to find out which is better when given prior to surgery to remove your cancer. The study drugs are Atezolizumab, Bevacizumab, Tiragolumab, and RO7247669.The CIT combinations are experimental drug treatments, which means health authorities have not approved them for the treatment of liver cancer in the neoadjuvant for treating cancer before surgery. Are you Eligible? (Inclusion Criteria) • Signed Informed Consent Form • Age ≥ 18 years at...
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING ATEZOLIZUMAB AND BEVACIZUMAB, WITH OR WITHOUT TIRAGOLUMAB, IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05904886

Population:

Adult

Phase:

III

The purpose of this study is to compare the effects, good or bad, of tiragolumab plus atezolizumab plus bevacizumab versus placebo plus atezolizumab plus bevacizumab on patients with HCC. In this study, participants will be randomized you will get either tiragolumab plus atezolizumab plus bevacizumab or placebo plus atezolizumab plus bevacizumab. A placebo looks like a drug but has no active ingredient.Tiragolumab has not been approved by FDA to treat HCC. Atezolizumab plus bevacizumab is currently the standard of care. Are you Eligible? (Inclusion Criteria) Age 18 years or older at the time...
A Phase 1b/2 Pressure Enabled Regional Immuno-Oncology Study of Hepatic Arterial Infusion of SD-101 with Systemic Checkpoint Blockade for Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05220722

Population:

Adult

Phase:

I/II

The purpose of this study is to determine the safety and best dose of SD-101 given by hepatic artery infusion (HAI, a method of putting medication directly into your liver) using Pressure- Enabled Drug Delivery (PEDD) alone or in combination with either pembrolizumab or in combination with nivolumab and ipilimumab. SD-101 works by limiting the expression, or present of, TLR9 in your body, which when present in large amounts, helps your tumor to grow. The study also aims to find out what effects (both good and bad) SD-101 given by HAI with PEDD has on you and your cancer when given alone or...
DISRUPT: Aim 2

Principal Investigator:

Mary Beth Terry, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05146297

Population:

Adult

Phase:

NA

That Black, Indigenous, and People of Color (BIPOC) are more likely to die from their cancer is well known. Despite years of progress in cancer research and treatment, most research is done in white populations. For this reason, it is not certain how best to treat BIPOC with cancer. The number of people with cancer who join a clinical trial (CT) in the United States at 8%. This low number is due to many reasons including the things related to the healthcare system, the number and type of clinical trials that are available, and the other illnesses patients have. These factors affect BIPOC...
AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT), A Phase 2/3 Study, An Intergroup Study by Société Internationale d’Oncologie Pédiatrique (SIOPEL) in collaboration with COG and the Japanese

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03533582

Population:

Pediatrics/Adult

Phase:

II/III

s phase 2/3 study is examining the best treatments for pediatric liver tumors. It is looking to improve survival for patients with a poor prognosis while potentially reducing therapy and the risk for side effects in patients with good prognoses. Hepatoblastoma and hepatocellular carcinoma are the liver tumors being studied. Are you Eligible? (Inclusion Criteria) Patients must be 30 years of age or younger Patients must have not previously received treatment for either hepatoblastoma or hepatocellular carcinoma Patients must also meet all eligibility criteria as outlined in the study protocol...
Phase I trial of ZEN003694 (ZEN-3694) in combination with capecitabine in patients with solid tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05803382

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of a drug called ZEN003694 (ZEN-3694), in combination with the usual approach of capecitabine. This study tests different doses of ZEN003694 in combination with capecitabine to see which dose is safer for people. There will be between 21 and 30 people taking part in this study. This drug combination is not approved by the FDA for treatment of the disease being studied. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Have you been diagnosed with metastatic or unresectable cancer, which progressed while you were treated...
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04794699

Population:

Adult

Phase:

I

IDE397 is an investigational drug, which has not been approved by health authorities for the treatment of people with your medical condition. It is currently not “on the market” (available for you to receive a prescription for and/or to buy) in any country. In this study, different dose levels of IDE397 will be tested. About 40 patients are expected to participate at approximately 6-8 study centers within the US. At a minimum, 2 patients will be enrolled in each dose level. There will be about 10 dose levels tested (starting at 5 mg). Every time a dose level is found to be safe, a...
A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05176483

Population:

Adult

Phase:

I

The purpose of this study is to evaluate the efficacy of the study drug, XL092 alone and/or in combination of other study drugs such as with nivolumab, nivolumab plus ipilimumab, or nivolumab/relatlimab fixed dose combination as a potential anticancer therapy to treat people with locally advanced or metastatic cancers including advanced renal cell cancer, castration-resistant prostate cancer, bladder cancer, liver cancer, lung cancer, colon cancer, head and neck cancer. Nivolumab has been approved as single agent for the treatment of melanoma, lung cancer, and bladder cancer and in...
Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP6306 Alone or in Combination with RP-3500 or Debio 0123 in Patients with Advanced Solid Tumors (MYTHIC Study)

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04855656

Population:

Adult

Phase:

I

The purpose of this research study is to test how safe RP-6306 is at different doses and schedules, test how well RP-6306 works to shrink cancer in the body, and evaluate if food affects the way RP-6306 moves through your body. This study will test the investigational drug, RP-6306, for the first time in humans. “Investigational” means that the study drug being tested has not been approved by the United States Food and Drug Administration (FDA). RP- 6306 is a PKMYT1 inhibitor (blocks the activity of the PKMYT1 protein) that is designed to stop certain cancer cells from growing...
A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients With Advanced CancerWith and Without Pembrolizumab

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT04130516

Population:

Adult

Phase:

I/II

This study is being done to determine if a new investigational drug, LNS8801, is safe and helpful in patients with cancer that have not improved and where there are no additional standard treatment options. LNS8801 is an agonist of the G protein-coupled estrogen receptor (GPER), meaning that it can bind to this protein and turn on signaling inside the cell. Studies in animals have shown that increasing GPER activity can inhibit the growth of many types of cancer, shrink the cancer, and help the immune system remove the cancer from the body. Some patients will also receive LNS8801 in...

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