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Peluntamig

Phase 1

Small Cell Lung Cancer (SCLC) | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 23, 2025

Target and mechanism

ModalitySmall molecule

Also known as Peluntamig (PT217)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment203

FDA Designations

No designations recorded

Clinical trial landscape

Peluntamig · 1 trial · 6 indications

Phase 1 1
NCT05652686A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)Small Cell Lung Cancer (SCLC)
RECRUITING203 Analytics
PHASE1RECRUITING
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
Small Cell Lung Cancer (SCLC)Unlock trial analytics

Study Endpoints

Primary Endpoints

To determine the dose-limiting toxicity (DLT) of Peluntamig (PT217).
Through study completion.
To determine the maximum tolerated dose (MTD) of Peluntamig (PT217) if reached.
Through study completion.
To determine recommended dose for expansion (RDE) of Peluntamig (PT217).
Through study completion.
To evaluate the safety and tolerability of Peluntamig (PT217).
Through study completion.
To evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments
Through study completion

Secondary Endpoints

To evaluate the pharmacokinetics of Peluntamig (PT217).
Through study completion.
To evaluate the immunogenicity (ADA) of Peluntamig (PT217).
Through study completion.
To further evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments
Through study completion.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Dose EscalationEXPERIMENTALA standard 3+3 dose escalation design will be employed.
Part B: Dose ExpansionEXPERIMENTALPart B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D.
Part C: Chemotherapy Combination TherapyEXPERIMENTALPart C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy.
Part D: ICI Combination TherapyEXPERIMENTALIn part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy.

Interventions

NameTypeDescription
Peluntamig (PT217)DRUGA bispecific antibody (bsAb) against DLL3 and CD47.
Carboplatin + EtoposideDRUGAdministered per Standard of Care.
Paclitaxel.DRUGAdministered per Standard of Care.
AtezolizumabDRUGAdministered per Standard of Care.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Key Inclusion Criteria 1. NECs that have transformed from NSCLC are not eligible. Part A: Patients with histologically or cytologically confirmed unresectable advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocr...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Small Cell Lung Cancer (SCLC)")

Frequently asked questions about Peluntamig

What is Peluntamig used for?

Peluntamig (PT217) is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer (SCLC). It is also being evaluated in other neuroendocrine carcinomas, including Large Cell Neuroendocrine Cancer, Neuroendocrine Prostate Cancer, and Gastroenteropancreatic Neuroendocrine Carcinoma, as part of the SKYBRIDGE study.

What does Peluntamig target?

Peluntamig targets DLL3, a protein expressed in neuroendocrine carcinomas. The drug is being studied in patients with tumors that express DLL3, including those with Small Cell Lung Cancer. The ongoing clinical trial is specifically designed for patients with DLL3-expressing neuroendocrine carcinomas.

Who makes Peluntamig?

Peluntamig is being developed by Roche Holding AG, a biopharmaceutical company traded on the OTC market under the ticker RHHBY. Roche is conducting the clinical development program for this investigational drug candidate.

What phase is Peluntamig in?

Peluntamig is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting patients to evaluate the safety and efficacy of Peluntamig in neuroendocrine carcinomas.

What clinical trials is Peluntamig in?

Peluntamig is being studied in a single Phase 1 clinical trial with the identifier NCT05652686, known as the SKYBRIDGE study. This trial is recruiting 203 patients in the United States with neuroendocrine carcinomas expressing DLL3, including Small Cell Lung Cancer. The study is controlled but not randomized or double-blinded.

Is Peluntamig the same as PT217?

Yes, Peluntamig is also known as PT217. Both names refer to the same investigational drug being developed by Roche for the treatment of DLL3-expressing neuroendocrine carcinomas, including Small Cell Lung Cancer. The clinical trial NCT05652686 uses the name Peluntamig (PT217) to identify the drug.