Recruiting
Phase 1

NPX887

Sponsor:

NextPoint Therapeutics, Inc.

Code:

NCT06240728

Conditions

Metastatic Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NPX887

Study Details

Brief summary:

NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 (HHLA2) expressing tumors at selected dose(s). The main questions it aims to answer are:

  • what is an appropriate dose to be given to participants?
  • are the side effects of treatment manageable?
  • what is the preliminary anti-tumor activities?

Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their disease has not progressed, and be closely monitored by the treating physicians.

Conditions

Metastatic Malignant Neoplasm

Study ID

NCT06240728

Start date

Jan 22, 2024

Status verified date

Mar, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Fresh tissue biopsies: Participants in Cohorts 2 and above in Phase 1a, the first 10 participants in each cohort of Part 1b, and the first 5 participants at each dose level in Part 1c cohort(s) will be required to have sufficient and adequate tumor tissue samples for a fresh screening biopsy and a mandatory on-treatment biopsy as clinically feasible.
  • 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 Criteria:

  • 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.

Study Design

Enrollment

144 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NPX887 Treatment

Participants will receive NPX887 by IV infusion every 3 weeks.

Interventions

NPX887

NPX887 will be administered by IV infusion every 3 weeks until documented disease progression or participant withdrawal for up to 2 years

Primary outcome measure

  • Incidence of dose limiting toxicity (DLT) [ Time Frame: From first dose through 21 days ]
  • Incidence of treatment-emergent adverse events (AEs) [ Time Frame: From first dose up to 24 months ]
  • Incidence of discontinuations, dosing interruptions, and dose reductions [ Time Frame: From first dose up to 24 months ]
  • Objective response rate (ORR) [ Time Frame: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first. ]
  • Duration of response (DOR) [ Time Frame: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first. ]
  • Disease control rate (DCR) [ Time Frame: Up to 2 years or until progressive disease, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first. ]
  • Progression-free Survival (PFS) [ Time Frame: Up to 2 years or until progressive disease, death, unacceptable toxicity, participant withdraw consent or investigator's decision, whichever occurs first. ]

Central Contacts and Locations

Central contacts

Trials nextpointtx

(888) 929-NEXTtrials@nextpointtx.com

Lauren Doherty

(888) 929-NEXTtrials@nextpointtx.com

Locations

Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Danielle Wendler

410-502-5140dschul15@jhmi.edu

Principal Investigator:

Yasser Ged, MD

Beth Israel Deaconess Medical Center (BIDMC)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Kati Mack

617-975-7459kmack3@bidmc.harvard.edu

Principal Investigator:

David McDermott, MD

Albert Einstein Medical College Montefiore Medical Center

Recruiting

Bronx, New York, United States, 10461

Contacts

Gunnar Lauer

glauer@montefiore.org

Principal Investigator:

Haiying Cheng, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Aung Naing, MD

713-563-3885anaing@mdanderson.org

Principal Investigator:

Aung Naing, MD

Next Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Brianna Flores

210-580-9521bflores@nextoncology.com

Principal Investigator:

Ildefonso I Rodriguez-Rivera, MD

NEXT Oncology-Fairfax

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

703-783-4505bpatterson@nextoncology.com

Principal Investigator:

Alexander Spira, MD, PhD

More Information

Sponsor

NextPoint Therapeutics, Inc.

Last update posted

Mar 7, 2025

Last verified

Mar, 2025

Keywords

  • B7-H7
  • HHLA2
  • solid tumor malignancies
  • monoclonal antibody
  • Dose escalation
  • Dose expansion
  • RECIST

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NextPoint Therapeutics, Inc. on 2025-03-07.