A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer

November 12, 2026 updated by: Novartis Pharmaceuticals

A Phase I, Open-label, Multi-center Study of TRB191 in Patients With Extensive Stage Small Cell Lung Cancer

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity (IG) and preliminary anti-tumor activity and to determine a recommended dose (RD) of TRB191 in patients with extensive-stage small cell lung cancer (ES-SCLC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase I, open-label, multi-center, first-in-human (FIH) study of TRB191 in adult patients with ES-SCLC. The study is comprised of a dose escalation part followed by a dose expansion part in second-line and beyond (2L+) ES-SCLC patients.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Israel
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Histologically or cytologically confirmed and documented ES-SCLC
  • Dose escalation: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor) according to the local standard of care (SOC). Prior treatment with a DLL3-targeted therapy is allowed, except in cohorts designed to evaluate TRB191 in patients who are naïve to prior DLL3-targeted therapy
  • Dose expansion: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor), according to the local SOC. Patients must have received prior treatment with tarlatamab

Exclusion Criteria:

  • Patients with inadequate bone marrow function and/or organ functions with out-of-range laboratory values
  • Impaired cardiac function or clinically significant cardiac disease
  • Presence of symptomatic central nervous system (CNS) metastases or CNS metastases requiring local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry
  • Treatment with anti-cancer therapies prior to the first dose of study treatment within the stated timeframes
  • Pregnant or nursing woman, and women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRB191 single agent

Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer.
Drug: TRB191

Subcutaneous injection of TRB191

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose intensity
Time Frame: Up to approximately 24 months

Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Up to approximately 24 months
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to approximately 24 months

Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Up to approximately 24 months
Incidence of Dose Limiting Toxicities (DLTs)
Time Frame: 21 days

Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, unless clearly and incontrovertibly assessed as due to underlying disease, disease progression, or intercurrent illness, that occurs within the first 21 days of treatment with TRB191. Other clinically significant toxicities may be considered DLTs, even if not CTCAE grade 3 or higher.
21 days
Frequency of dose interruptions and reductions
Time Frame: Up to approximately 24 months

Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability.
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum serum concentration (Cmax) of TRB191
Time Frame: From pre-dose up to 120 or 240 hours post-dose

Pharmacokinetic (PK) parameters based on serum concentrations of TRB191. Cmax will be determined using non-compartmental method(s).
From pre-dose up to 120 or 240 hours post-dose
Time to reach maximum serum concentration (Tmax) of TRB191
Time Frame: From pre-dose up to 120 or 240 hours post-dose

PK parameters based on serum concentrations of TRB191. Tmax will be determined using non-compartmental method(s).
From pre-dose up to 120 or 240 hours post-dose
Arean under the serum concentration-time curve (AUC) of TRB191
Time Frame: From pre-dose up to 120 or 240 hours post-dose

PK parameters based on serum concentrations of TRB191. AUC will be determined using non-compartmental method(s).
From pre-dose up to 120 or 240 hours post-dose
Number of participants with anti-drug antibodies (ADA)
Time Frame: From baseline (pre-dose) up to approximately 24 months

Number of participants with anti-TRB191 antibodies during treatment.
From baseline (pre-dose) up to approximately 24 months
Overall Response Rate (ORR) per RECIST v1.1
Time Frame: Up to approximately 24 months

ORR is defined as the proportion of patients with a best overall response (BOR) of Complete response (CR) or Partial response (PR) as per local review and according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1).
Up to approximately 24 months
Disease Control Rate (DCR) per RECIST v1.1
Time Frame: Up to approximately 24 months

DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease as per local review and according to RECIST v1.1.
Up to approximately 24 months
Duration of Response (DOR) per RECIST v1.1
Time Frame: Up to approximately 24 months

DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v 1.1, or death due to any cause.
Up to approximately 24 months
Progression-Free Survival (PFS) per RECIST v1.1
Time Frame: Up to approximately 24 months

PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or death due to any cause.
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 17, 2026

Primary Completion (Estimated)

July 30, 2030

Study Completion (Estimated)

July 30, 2030

Study Registration Dates

First Submitted

October 26, 2026

First Submitted That Met QC Criteria

October 26, 2026

First Posted (Actual)

November 2, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 12, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRB191A12101
  • 2026-526463-37 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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