A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2025-09-20

Brief Summary

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NPX267 is an antibody drug targeting the inhibitory receptor for B7-H7 (HHLA2) which may control evasion of the immune response in tumors. The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer. The main questions it aims to answer are:

* what is an appropriate dose to be given to patients?
* are the side effects of treatment manageable?

Participants will be evaluated for participation in the study. Patients who are treated will receive an intravenous infusion of NPX267 every three weeks if their disease has not progressed. Patients will be closely monitored by the treating physician.

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Detailed Description

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This trial is divided into two parts. The first part (dose escalation) will test different doses of drug to find a dose for part two. In the second part (dose expansion), more patients will be tested to see if the drug has an effect on patient's tumors.

Throughout the study, data will be collected to characterize the clinical activity of the drug. Samples of blood will be taken to help in an understanding of how the drug behaves in the body by assessing the amount of drug in the blood over time (pharmacokinetics), and changes in blood components (pharmacodynamics and safety). Tumor imaging by computed tomography (CT) or magnetic resonance imaging (MRI) will be done about every nine weeks to assess NPX267 impact on tumor growth.

Conditions

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Metastatic Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Dose escalation and dose expansion

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NPX267 Treatment

Group Type EXPERIMENTAL

NPX267

Intervention Type DRUG

NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal

Interventions

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NPX267

NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to standard of care therapy in one of the following indications: Part 1a: non-small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), cholangiocarcinoma (CCA), pancreatic cancer (PDAC), urothelial carcinoma (UCC), gastric/gastroesophageal carcinoma, triple negative breast carcinoma, endometrial carcinoma, cervical cancer, osteosarcoma, and prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Normal bone marrow, kidney and liver function
* Willing to use highly effective contraceptive measures throughout the trial

Exclusion Criteria

* Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy \> 6 months, or changes in skin pigmentation
* Have known or suspected brain metastases, unless they are clinically stable
* Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily
* History of grade 3 immune-related pneumonitis or colitis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No