Active — Not RecruitingPhase 1/2

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

United States232 participantsStarted 2020-12-14

Plain-language summary

This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histologically or cytologically confirmed malignancy associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3) * Has small cell lung cancer (SCLC) which is relapsed/refractory following at least 1 prior line of systemic therapy that included platinum-based chemotherapy * Has Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which is relapsed/refractory to standard systemic therapy * Has high-grade neuroendocrine tumor types other than SCLC and NEPC, with at least one of the following: * Disease that is relapsed/refractory to standard systemic therapy * Disease for which standard therapy does not exist * Disease for which standard therapy is not considered appropriate by the Investigator * Must be able to provide archival tissue sample or fresh biopsy tissue sample Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has untreated central nervous system (CNS) metastases * Has a glioma or other primary CNS malignancy * Has spinal cord compression or symptomatic/uncontrolled epidural disease * Has a history of intracranial hemorrhage or spinal cord hemorrhage * Has active neurologic paraneoplastic syndrome * Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (e.g., biweekly or more frequently) * Has active or history of autoimmune dise…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants who experience an adverse event

Timeframe: Up to ~4 years

Percentage of participants who discontinue due to an adverse event

Timeframe: Up to ~4 years

Number of participants with dose limiting toxicity (DLT) following treatment with HPN328 as monotherapy or in combination with atezolizumab or I-DXd

Timeframe: Up to ~4 years

Maximum concentration (Cmax) of Gocatamig

Timeframe: At designated time points up to ~4 years

Cmax of Atezolizumab

Timeframe: At designated time points up to ~4 years

Cmax of I-DXd

Timeframe: At designated time points up to ~4 years

Time to maximum concentration (Tmax) of Gocatamig

Timeframe: At designated time points up to ~4 years

Trial details

NCT IDNCT04471727

SponsorHarpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-28

View on ClinicalTrials.gov More Small-Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Percentage of participants who experience an adverse event

Timeframe: Up to ~4 years

Percentage of participants who discontinue due to an adverse event

Timeframe: Up to ~4 years

Number of participants with dose limiting toxicity (DLT) following treatment with HPN328 as monotherapy or in combination with atezolizumab or I-DXd

Timeframe: Up to ~4 years

Maximum concentration (Cmax) of Gocatamig

Timeframe: At designated time points up to ~4 years

Cmax of Atezolizumab

Timeframe: At designated time points up to ~4 years

Cmax of I-DXd

Timeframe: At designated time points up to ~4 years

Time to maximum concentration (Tmax) of Gocatamig

Timeframe: At designated time points up to ~4 years