Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement

NCT06073938 | Recruiting

• 1 other identifier: BRD-870 RWS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The NHWD-870 Phase I clinical trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced tumors. The objectives of this retrospective study were to preliminarily evaluate the anti-tumor efficacy of NHWD-870 HCl in patients with advanced solid tumors or lymphomas and to preliminarily evaluate biomarkers associated with the efficacy of NHWD-870 HCl in the treatment of patients with advanced solid tumors or lymphomas, to provide a basis for identifying the enriched population for the late-stage trial.

Conditions

Advanced Solid Tumors or Lymphomas

Outcome Measures

Primary Outcomes (1)

• ORR

  Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements.

  1.5 years

Interventions

NHWD-870 DRUG

The base dosage administered is 2.0 mg/dose/day, and the frequency and dose of administration may be adjusted based on safety data.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

advanced solid tumors or lymphomas, NUT rearrangement positive

You may qualify if:

• Signing an informed consent form;
• Patients with advanced solid tumors or lymphomas definitively diagnosed by pathology;
• Age ≥18 and ≤75 years;
• Eastern Cooperative Oncology Group (ECOG) score physical status score of 0 to 1;
• Expected survival of \>3 months;
• NUT positive confirmed by molecular testing.

You may not qualify if:

• Subjects who meet one or more of the following criteria will be excluded:
• Other serious complications (such as uncontrolled infection, myocardial infarction within 6 months, high blood pressure (≥ 160/100mmHg) and thromboembolic disease that cannot be controlled by drug intervention, etc.);
• The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 5.0 ≤ Grade1 (except for hair loss, anemia and other toxicities judged by researchers to be unsafe);
• History of substance abuse;
• Inability to take drugs due to dysphagia (except for patients who receive nutrients through a gastric tube due to dysphagia), or conditions that the investigator determines seriously affect gastrointestinal absorption;
• Patients with a history of other serious systemic diseases who are judged by the investigator to be unsuitable for participating in clinical trials;
• Alcoholics or those who drink more than 28 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits or 1 glass of wine);
• Suffering from uncontrollable mental illness;
• Pregnant or lactating women, or patients of childbearing age (including male subjects) with pregnancy plans;
• Active hepatitis B (viral titer \>103), hepatitis C or HIV ( );
• Long-term treatment with high-dose corticosteroids or other immunosuppressants, such as those who have undergone organ transplantation, or those who have received systemic glucocorticoids (such as prednisone\> 10 mg/day or equivalent drugs) or other immunosuppressant therapy within 14 days before the first use of the study drug; Exceptions are given for topical, ocular, intra-articular, intranasal and inhaled corticosteroid therapy; short-term use of glucocorticoids for prophylaxis (e.g., prevention of contrast allergy);
• The investigator believes that the subject is not suitable to participate in this clinical study for other objective reasons.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples，tumor tissue samples (by puncture, incision or clamping)

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy Director of Thoracic Oncology Department

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: September 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)