A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06807632
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Valemetostat — DRUG
    Dose level -1 100 mg po once daily Dose level 1 150 mg po once daily Dose level 2 200 mg po once daily
  • Atezolizumab — DRUG
    1680 mg IV q4weeks

Study Details

This study will test whether valemetostat in combination with atezolizumab is a safe treatment that causes few or mild side effects in people with extensive-stage small cell lung cancer (SCLC). The researchers will test different doses of valemetostat to find the highest dose that causes few or mild side effects in participants. After the dose is found, researchers will test it in a new group of participants to learn more about the safety of the study treatment and see if it is an effective treatment for extensive-stage SCLC.

Key Dates

Start date
Jan 29, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Valemetostat in Combination With Atezolizumab
    This is a single institution phase 1 study to assess the safety of valemetostat when used in combination with atezolizumab for the treatment of extensive-stage SCLC patients. We will begin enrollment at a valemetostat dose of 150 mg once daily (dose level 1), with atezolizumab given per standard of care 1680 mg intravenously every four weeks. The study will have two phases, a dose finding phase and an expansion phase.

Primary Outcome Measure

Determine Phase II dose (RP2D) [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Jessica Ross, MD
646-608-4422
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Jessica Ross, MD
646-608-4422
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Jessica Ross, MD
646-608-4422
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Jessica Ross, MD
646-608-4422
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Jessica Ross, MD
646-608-4422
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Jessica Ross, MD
646-608-4422
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Jessica Ross, MD
646-608-4422

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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