CompletedPhase 1

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

United States110 participantsStarted 2016-02-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

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

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

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

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

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

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

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

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

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

Trial details

NCT IDNCT02635672

SponsorVincerx Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-11

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