Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

Study summary

The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBerzosertib and Berzosertib

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 26, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?51 U.S. locations

Locations may change over time.

Who runs it?EMD Serono Research & Development Institute, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: EMD Serono Research & Development Institute, Inc.
Interventions being studied: Drug: Berzosertib; Drug: Berzosertib; Drug: Topotecan

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Dose level 1 participants with histologically proven advanced solid tumors, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated
Dose level 1 participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (\<=) 1 and Karnofsky Scale greater than or equal to (\>=) 70 percent (%)
Dose level 2 and main part participants with ECOG PS \<= 2 and Karnofsky Scale \>= 60%
Dose level 2 and main part participants with histologically confirmed SCLC
Dose level 2 and main part participants with radiologically confirmed progression after first-line or chemoradiation platinum-based treatment (carboplatin or cisplatin), with or without immunotherapy, for treatment of limited or extensive stage SCLC, with a Platinum-free interval (PFI) less than (\<) 90 days. The PFI is measured by the elapsed time from the last day of the regimen of a platinum-based treatment until the first day of documented disease progression
Dose level 2 and main part participants with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECISTv1.1) at Screening. Evidence of measurable disease must be confirmed by the IRC prior to start of treatment
Tumor tissue provision: archival (collected within 12 months before date of informed consent form \[ICF\]) signature for Screening) or fresh biopsy specimen, if medically feasible
Have adequate hematologic and renal function
Other protocol defined inclusion criteria could apply

Reasons someone may not be able to joinExclusion criteria

Clinically relevant (that is \[i.e.\], active), uncontrolled intercurrent illness including, but not limited to, severe active infection including, severe acute respiratory syndrome coronavirus-2 infection/coronavirus disease 2019, immune deficiencies, uncontrolled diabetes, uncontrolled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification greater than or equal to \[\>=\] Class III), unstable angina pectoris, myocardial infarction, uncontrolled cardiac arrhythmia, cerebral vascular accident/stroke. Calculated corrected QT interval (QTc) average (using the Fridericia correction calculation) of greater than \[\>\] 450 millisecond (msec) for males and \> 470 msec for females. Any psychiatric illness/social situations that would limit compliance with study requirements
Unstable brain metastases; however, participants with known brain metastases may be enrolled in this clinical study if they are clinically stable (without evidence of progression by imaging for at least 2 weeks prior to the first study intervention dose and any neurologic symptoms have returned to baseline), have no evidence of new brain metastases, and are on a stable or decreasing dose of steroids for at least 14 days prior to study intervention Participants with carcinomatous meningitis are excluded regardless of clinical stability. Screening central nervous system imaging is not mandatory
Prior malignant disease within the last 3 years. Exceptions include fully resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ cervical cancer, fully resected ductal carcinoma in situ of the breast, superficial or noninvasive bladder cancer, and Stage IA, Grade I endometrioid endometrial cancer with no myometrial invasion, that has undergone curative therapy. Participants with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor
Participants not recovered from adverse events (AEs) Grade \> 1 from prior anticancer therapies, including surgeries. Exception: Grade 2 AEs not constituting a safety risk (for example \[e.g.\], alopecia), based on the Investigator's judgment; must consult with the medical Monitor prior to enrollment.
Other protocol defined

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Providence Medical FoundationSanta Rosa, California
St Joseph Heritage HealthcareSanta Rosa, California
Cotton-O'Neil Clinical Research Center, Hematology and OncologyTopeka, Kansas
National Cancer InstituteBethesda, Maryland
Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan
MidAmerica Cancer CareKansas City, Missouri
NJ Center for Cancer ResearchBrick, New Jersey
Southeastern Medical Oncology CenterGoldsboro, North Carolina
FirstHealth of the Carolinas, Inc.Pinehurst, North Carolina
Summa HealthAkron, Ohio
Toledo ClinicToledo, Ohio
Millennium Physicians Association, LLPHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 26, 2024. Always confirm current availability with the study team.

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