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Completed

NCT Number: NCT02635672

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

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).

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Key information

Conditions

Neoplasms Adenocarcinoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Transitional Cell DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Head and Neck Neoplasms Infections Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Polyomavirus Infections Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centro de Investigaciones Clínicas Viña del Mar, Viña del Mar, Valparaiso, Chile

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)

Inclusion criteria

  • Male or female patients aged >/=18 years
  • Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies with MYC expression or known C-MYC amplification/alterations
  • Adequate bone marrow, liver, and renal functions
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

In the addition to the above Part 3 (US Only) and Part 4 (US Only)

  • Must be eligible to use pembrolizumab per USPI

Exclusion criteria

  • Active clinically serious infections of events > Grade 2
  • Subjects who have new or progressive brain or meningeal or spinal metastases.
  • Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug
  • Major surgery or significant trauma within 4 weeks before the first dose of study drug
  • Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.

Treatment and study plan

VIP152 (BAY 1251152)

Drug

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

Drug

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

Keytruda

Drug

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

Other names: pembrolizumab

VIP152 (BAY 1251152) 15 mg

Drug

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.

Primary outcomes

  1. Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  2. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP152 (BAY1251152)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  3. Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  4. AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  5. Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  6. AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  7. Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  8. Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152) in combination with Keytruda® (pembrolizumab)

    Time frame: Cycle 1 Day 1 through Cycle 3 Day 1, where each cycle is up to 21 days

  9. Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab)

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days

  10. Number of participants with adverse events as a measure safety and tolarability

    Time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)

Secondary outcomes

  1. Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL)

    Time frame: Up to 3 Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)

Sponsors and collaborators

Lead sponsor

Vincerx Pharma, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2015
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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