Recruiting PHASE2 Hepatocellular Carcinoma

New treatment option for Hepatocellular Carcinoma

Official title Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC

ClinicalTrials.gov ID: NCT05733598

What this study is testing

What is RP2?

RP2 is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally advanced unresectable, recurrent, and/or metastatic HCC and in combination with durvalumab as treatment in patients with unresectable locally advanced or metastatic BTC.

Phase 2: a mid-size study of how well it works
Time commitment: about 3 years

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

Key I 1. Male or female ≥ 18 years of age. I 2. (HCC only) Has locally advanced unresectable, recurrent, and/or metastatic HCC, with the diagnosis...
Female patients are eligible if not pregnant (see IC #15) or breastfeeding and if one of the following applies 1) is a woman of non-childbearing...
Male patients are eligible to participate if they agree to the following during the study treatment period, and for at least 90 days after the last...

You likely can't join if

E 1. (HCC only) Child-Pugh B or C. E 2. (HCC only) Patients with untreated or incompletely treated esophageal and/or gastric varices with bleeding or...
Note: Note: All patients in Cohort 1a and 1b must undergo an esophagogastroduodenoscopy (EGD), and all varices (irrespective of size) must be...
Note: EGD is not required for patients in Cohort 2 (RP2 monotherapy). E 3. Significant bleeding event within the last 12 months that places the...
E 4. (HCC only) Macroscopic intravascular invasion into the hepatic and/or portal vein(s) (ie, no Vp4), , vena cava, and/or other major blood vessel...
E 5. (HCC only) Histologic evidence of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma with HCC, or other rare HCC variants.
E 6. History of medically refractory hepatic encephalopathy and/or hepato-renal syndrome.

See the full eligibility criteria

Who can join

Key I 1. Male or female ≥ 18 years of age. I 2. (HCC only) Has locally advanced unresectable, recurrent, and/or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features or...
Female patients are eligible if not pregnant (see IC #15) or breastfeeding and if one of the following applies 1) is a woman of non-childbearing potential (WNCBP) OR 2) is a woman of childbearing potential and must...
Male patients are eligible to participate if they agree to the following during the study treatment period, and for at least 90 days after the last dose of RP2: refrain from donating fresh unwashed sperm plus either be...

What rules you out

E 1. (HCC only) Child-Pugh B or C. E 2. (HCC only) Patients with untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding.
Note: Note: All patients in Cohort 1a and 1b must undergo an esophagogastroduodenoscopy (EGD), and all varices (irrespective of size) must be assessed and treated regardless of grade before enrollment. Patients who have...
Note: EGD is not required for patients in Cohort 2 (RP2 monotherapy). E 3. Significant bleeding event within the last 12 months that places the patient at unjustifiable risk for bleeding from intratumoral injection...
E 4. (HCC only) Macroscopic intravascular invasion into the hepatic and/or portal vein(s) (ie, no Vp4), , vena cava, and/or other major blood vessel, or into the common bile duct(s).
E 5. (HCC only) Histologic evidence of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma with HCC, or other rare HCC variants.
E 6. History of medically refractory hepatic encephalopathy and/or hepato-renal syndrome.
E 7. Disease that is amenable to curative surgical and/or locoregional therapies.
E 8. Presence of liver tumors that are estimated to invade more than one-third of the liver.
E 9. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage within 7 days before enrollment.
E 10. Hepatitis B virus (HBV) DNA \> 500 IU/mL obtained within 28 days prior to initiation of study treatment. Co-infection of HBV and hepatitis C virus (HCV) is not allowed.
Note: Patients with HBV DNA ≤ 500 U/mL are eligible to enroll in the study. Patients must be on anti-HBV treatment (per local standard care that do not have activity with HSV. Entecavir, tenofovir, telbivudine...
E 11. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.
E 12. Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or IV) antivirals with known...
Note: Patients with sporadic cold sores may be enrolled if no active cold sores are present at the time of Dose 1 Day 1.
E 13. Systemic infection requiring IV antibiotics or other serious infection within 14 days before dosing.
E 14. Received a live vaccine within 28 days before the first dose of study treatment.
E 15. Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
E 16. Prior malignancy, other than HCC and BTC, active within the previous 3 years, except for localized cancers that have apparently been cured or only required surveillance (eg. basal or squamous cell skin cancer...
E 17. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment.
Note: Patients who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent.
E 18. Systemic anticancer therapies within 4 weeks of the first dose of study drug.
Note: Patients must have recovered (to Grade ≤ 1 or baseline) from all AEs due to previous therapies. Patients with Grade ≤ 2 neuropathy may be eligible if approved by the Medical Monitor.
E 19. Received radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities (except for radiation-induced xerostomia), not require corticosteroids, and not...
E 20. Received prior treatment with an oncolytic virus therapy. E 21. History of significant cardiac disease including myocarditis or congestive heart failure (defined as New York Heart Association Functional...
E 22. Uncontrolled infection requiring intravenous antibiotics. E 23. History of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), non-infectious pneumonitis...
Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
E 24. Active tuberculosis. E 25. History or evidence of psychiatric, substance abuse, or any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the...
E 26. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is...
E 27. Active, known, or suspected autoimmune disease requiring systemic treatment.
Note: Patients with type 1 diabetes mellitus and/or hypothyroidism requiring only hormone replacement, and/or with autoimmune skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment...
E 28. Conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids within 14 days before Dose 1 Day 1.
Note: Patients who require a brief course (≤ 7 days) of corticosteroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic...
E 29. Sensitivity to any of the study interventions, or components or thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
E 30. History of life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T lymphocyte antigen 4 or anti-PD-1/anti-PD-L1 treatment or any other antibody or drug specifically targeting T-cell...
E 31. (HCC only) Current or recent (within 10 days of first dose of study treatment) use of aspirin or treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol. Current or recent (within 10 days prior to...
Note: Prophylactic anticoagulation for the patency of venous access devices is allowed.
E 32. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks before treatment.
E 33. Prior organ transplantation including allogeneic stem-cell transplantation.
E 34. (HCC only) Major surgery within 28 days before starting bevacizumab or anticipated major surgery while on study.
Note: If a patient received major surgery, they must have recovered adequately from the intervention before starting study treatment and must have adequate wound healing, based on Investigator's assessment or surgeon's...
E 35. (BTC only) Ampullary carcinoma or mixed cholangiocarcinoma with HCC. E 36. (BTC only) Patients with mismatch repair deficiency and microsatellite instability-high are excluded.

The study team makes the final eligibility decision.

Where it's taking place

Beverly Hills, California, United States
La Jolla, California, United States
Miami, Florida, United States
Tampa, Florida, United States
Baltimore, Maryland, United States
Buffalo, New York, United States
The Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Knoxville, Tennessee, United States
Houston, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beverly Hills, California, United States; La Jolla, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Baltimore, Maryland, United States; Buffalo, New York, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.