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Study of NPX887 for Solid Tumors Expressing B7-H7/HHLA2

This study is testing a new drug called NPX887 for people with solid tumors that have spread (metastatic malignant neoplasm) and express a specific marker called B7-H7 (HHLA2). NPX887 is a monoclonal antibody, which is a type of protein designed to target specific cells. It aims to boost your body's immune response against cancer. The main goals are to find a safe and effective dose of NPX887, understand its side effects, and see if it can shrink tumors. You would receive NPX887 through an IV (intravenous) infusion every three weeks for up to two years, as long as your disease doesn't worsen. This study is for adults aged 18 and older whose cancer has not responded to standard treatments.

Study design
This is an interventional study with a planned enrollment of 144 participants. It has different parts, including a dose escalation phase to find the best dose and a dose expansion phase to further evaluate the drug.
What's involved
You would receive IV infusions of NPX887 every three weeks and be closely monitored by doctors. Blood and tumor tissue samples will be collected at various times.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 24 months after your first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06240728

A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2

Recruiting
PHASE1Ages 18+InterventionalTreatment
NextPoint Therapeutics, Inc.
~144 participants
Updated 2025-06-27 on ClinicalTrials.gov
What's tested:NPX887

At a glance

Recruiting sites
2 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicity (DLT)
Measured over From first dose through 21 days
+6 more outcomes measured

Conditions

Metastatic Malignant Neoplasm

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Colorectal CarcinomaEsophageal AdenocarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaLung Non-Small Cell CarcinomaLung Small Cell CarcinomaMalignant neoplasm of biliary tractMalignant Ovarian NeoplasmRenal Cell CarcinomaSolid NeoplasmHERV-H LTR-Associating Protein 2

Where it's being run

8 sites across 6 states
Texas2
South Korea2
Maryland1
Massachusetts1
New York1
Virginia1

Study leadership

  • Leena Gandhi, MD, PhD · STUDY_DIRECTOR · NextPoint

Who to contact

Trials nextpointtx
[email protected]
(888) 929-NEXT
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to, or intolerant of, standard of care therapy in one of the following indications:
Phase 1a (Dose Escalation): Non-small cell lung carcinoma (NSCLC), small cell lung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliary tract cancers, ovarian carcinoma, and other solid tumor types known to express B7-H7/HHLA2.
Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison): participants who have clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
In Phase 1b, participants must have confirmed B7-H7/HHLA2 expression in their tumor determined via archival tissue IHC testing through a central lab (pre-screening).
Phase 1a: Evaluable disease (measurable or non-measurable) by RECIST v.1.1 criteria; Phase 1b: Measurable disease by RECIST v1.1 criteria with additional disease-specific enrollment criteria applied to clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Ability to understand and the willingness to sign a written informed consent document
Willing to use highly effective contraceptive measures throughout the trial.

Exclusion

Treatment with any of the following:
Systemic anticancer treatment ≤14 days or within 5 half-lives prior to the first dose of study drug, whichever is shorter.
Limited-field radiotherapy ≤7 days or extended-field thoracic radiotherapy ≤8 weeks of the first dose of study drug.
Have any unresolved toxicity of ≥Grade 2 from previous anti-cancer treatment, except for alopecia, chronic stable neuropathy for \>4 months, changes in skin pigmentation, or requiring replacement therapy for endocrine abnormalities.
Participants with known brain metastases are excluded unless they are clinically stable, with no new or enlarging brain metastases as evidenced on MRI during screening.
History of Grade 3 immune-related pneumonitis or colitis.
Participants who discontinued prior immunotherapy due to immune-related toxicities, or history of unresolved prior immune-related toxicity except for endocrine abnormalities requiring replacement therapy or vitiligo.
Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily.

What this trial measures

  • Incidence of dose limiting toxicity (DLT)From first dose through 21 days

    Number of participants with DLT in Ph1a

  • Incidence of treatment-emergent adverse events (AEs)From first dose up to 24 months

    Number and type of AEs categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in Ph1a

  • Incidence of discontinuations, dosing interruptions, and dose reductionsFrom first dose up to 24 months

    Number of participants with changes to their dosing schedule as a result of treatment-related AEs in Ph1a

  • Objective response rate (ORR)Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.

    The proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 in Ph1b

  • Duration of response (DOR)Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.

    The time interval from first occurrence of a documented objective response to the time of disease progression as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first, in Ph1b

  • Disease control rate (DCR)Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.

    The proportion of participants with a best ORR + Stable Disease (SD) in Ph1b

  • Progression-free Survival (PFS)Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first.

    The duration from the start of treatment until tumor progression or death of any cause in Ph1b