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NeoplasmsPhase 1NCT02635672

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

A Phase 1 study testing VIP152 (BAY 1251152), VIP152 (BAY 1251152) 30 mg and Keytruda in people with Neoplasms, run by Vincerx Pharma, Inc. at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
VIP152 (BAY 1251152), VIP152 (BAY 1251152) 30 mg and Keytruda
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
16 sitesin 3 countries
Study dates
10 Feb 2016to 11 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

United States13 sites

  • NEXT Oncology

    Austin, Texas, 78758

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

  • Avera Health

    Sioux Falls, South Dakota, 57105

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

Other trials in United States

Chile2 sites

  • Centro de Investigaciones Clínicas Viña del Mar

    Viña del Mar, Valparaiso, 2540364

  • Oncocentro

    Viña del Mar, 2520598

Other trials in Chile

Spain1 site

  • START Madrid- Fundación Jiménez Diaz

    Madrid, 28040

Other trials in Spain

About this study

Official 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.

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).

Read the detailed description

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).

Conditions
Neoplasms
Being tested
VIP152 (BAY 1251152), VIP152 (BAY 1251152) 30 mg, Keytruda, VIP152 (BAY 1251152) 15 mg
Keywords
Solid tumors, Aggressive non-hodgkin's lymphoma (NHL), Advanced Ovarian Cancer, Triple Negative Breast Cancer, DHL, Double-Hit Lymphoma, Transformed Follicular Lymphoma, Mantle Cell, Prostate Cancer, Melanoma, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Cancer, Esophageal Cancer, Urothelial Carcinoma, Tumor Mutational Burden-High Cancer, Cutaneous Squamous Cell Carcinoma, Microsatellite Instability-High or Mismatch Repair Deficient Cancer, Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer, Gastric Cancer, Cervical Cancer
Medical subject headings
Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Carcinoma, Transitional Cell, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 mgDrug

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

  • KeytrudaDrug

    Also called pembrolizumab

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

  • VIP152 (BAY 1251152) 15 mgDrug

    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.

Study groups in NCT02635672
Study groupRoleWhat they receive
Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)ExperimentalInvestigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL
Receives: Drug: VIP152 (BAY 1251152)
Dose expansion of VIP152 (BAY 1251152) / PART 2ExperimentalInvestigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL
Receives: Drug: VIP152 (BAY 1251152) 30 mg
Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3ExperimentalInvestigating 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.
Receives: Drug: Keytruda; Drug: VIP152 (BAY 1251152) 15 mg
Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4ExperimentalInvestigating 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.
Receives: Drug: VIP152 (BAY 1251152) 30 mg; Drug: Keytruda

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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)

  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)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2015 (estimated)
  2. Study start10 Feb 2016
  3. Primary completion11 Nov 2024
  4. Study completion11 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02635672
Sponsor's protocol ID
VNC-152-101
Other IDs
2014-004808-30, 2014
Status last verified
Nov 2024
First submitted
17 Dec 2015
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Diamond JR, Boni V, Lim E, Nowakowski G, Cordoba R, Morillo D, Valencia R, Genvresse I, Merz C, Boix O, Frigault MM, Greer JM, Hamdy AM, Huang X, Izumi R, Wong H, Moreno V. First-in-Human Dose-Escalation Study of Cyclin-Dependent Kinase 9 Inhibitor VIP152 in Patients with Advanced Malignancies Shows Early Signs of Clinical Efficacy. Clin Cancer Res. 2022 Apr 1;28(7):1285-1293. doi: 10.1158/1078-0432.CCR-21-3617.

    PubMed 35046056

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VIP152 (BAY 1251152), VIP152 (BAY 1251152) 30 mg and Keytruda in people with Neoplasms, run by Vincerx Pharma, Inc. at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Chile, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02635672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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