Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Infections

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Stomach Neoplasms

Prostatic Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Esophageal Neoplasms

Lymphoma

Triple Negative Breast Neoplasms

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Microsatellite Instability

Carcinoma, Transitional Cell

Lymphoma, Follicular

Lymphoma, B-Cell

Aggression

Carcinoma, Merkel Cell

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Lymphosarcoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Follicular Lymphoma

B-cell Lymphoma

Merkel Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL

Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL

Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.

Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.

The starting dose of Cohort 1 will be 5 mg IV (30 minute infusion) fixed dose once weekly (5 mg/week) for 21 day cycles.

VIP152 (BAY 1251152)

30 mg IV (30 minute infusion) fixed dose once weekly of a 21 day cycle.

VIP152 (BAY 1251152) 30 mg

200 mg IV fixed dose once every 3 weeks of a 21 day cycle

Keytruda

The starting dose of Cohort 3 will be 15 mg IV (30 minute infusion) fixed dose once weekly (15 mg/week) for 21 day cycles.

VIP152 (BAY 1251152) 15 mg

Vincerx Study Director

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).

Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).

Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer

An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of VIP152 (BAY 1251152) as Monotherapy or Combination Therapy in Subjects With Advanced Cancer.

Vincerx Pharma, Inc.

Diseases and Abnormalities at or Before Birth

Lymphoma, Large B-Cell, Diffuse

Congenital Abnormalities

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Diffuse Large B-Cell Lymphoma

Amino Acids

Zanubrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

zanubrutinib

Qunling Zhang, doctor

This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.

This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.

ZR-CHOP in DLBCL With Specific Gene Abnormality

Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality

From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

From date of enrollment until the date of an event, including progression, death from any cause, new treatment.

From date of enrollment until the date of death from any cause

Fudan University

Principal Investigator

Syndrome

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Richter Syndrome

Investigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome

Investigating VIP152 in combination with a BTKi in patients with CLL

VIP152

BTKi

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome

A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

An Open-label, Multicenter Phase 1/1b Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP152 Monotherapy or Combination Therapy in Subjects With High-risk Chronic Lymphocytic Leukemia or Richter Syndrome

Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy

Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome

Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per applicable response criteria

Number of Participants Without Disease Progression per iwCLL guidelines for CLL \& Lugano Classification for NHL

Maximum observed drug concentration in measured administration (Cmax) of VIP152

time from first dose to the initiation of next dose or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer	NCT02635672	Neoplasms	VIP152 (BAY 125... VIP152 (BAY 125... Keytruda VIP152 (BAY 125...	18 Years -	Vincerx Pharma, Inc.
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer	NCT02635672	Neoplasms	VIP152 (BAY 125... VIP152 (BAY 125... Keytruda VIP152 (BAY 125...	18 Years -	Vincerx Pharma, Inc.
ZR-CHOP in DLBCL With Specific Gene Abnormality	NCT05290337	Diffuse Large B...	zanubrutinib	18 Years - 75 Years	Fudan University
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer	NCT02635672	Neoplasms	VIP152 (BAY 125... VIP152 (BAY 125... Keytruda VIP152 (BAY 125...	18 Years -	Vincerx Pharma, Inc.
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer	NCT02635672	Neoplasms	VIP152 (BAY 125... VIP152 (BAY 125... Keytruda VIP152 (BAY 125...	18 Years -	Vincerx Pharma, Inc.
ZR-CHOP in DLBCL With Specific Gene Abnormality	NCT05290337	Diffuse Large B...	zanubrutinib	18 Years - 75 Years	Fudan University
A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome	NCT04978779	Relapsed Non Ho... Chronic Lymphoc... Refractory Chro... Richter Syndrom... MYC Amplificati... MYC Overexpress... MYC Translocati...	VIP152 BTKi	18 Years -	Vincerx Pharma, Inc.

Spots Global Cancer Trial Database for myc translocation