Testing HRS-6719 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a Phase I/II, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of HRS-6719 in patients with advanced or metastatic solid tumors that are deficient in MTAP. The trial includes dose escalation and expansion phases to determine the optimal dosing and pharmacokinetic/pharmacodynamic profiles of the treatment. Participants will be monitored for antitumor efficacy and overall health outcomes throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must voluntarily participate in the study and sign an informed consent form;
2. Aged 18-75 years, male or female eligible；
3. ECOG performance status score of 0-1；
4. Expected survival ≥12 weeks；
5. Patients with histologically or cytologically confirmed advanced malignant solid tumors who meet one of the following criteria:Disease progression or intolerance after receiving adequate standard therapy; Lack of standard treatment options;Currently ineligible for standard therapy；
6. Ability to provide sufficient fresh or archived tumor tissue specimens；
7. Adequate function of vital organs；
8. Effective contraception must be used during the trial. For women of childbearing potential, a negative pregnancy test within 7 days prior to the first dose is required。

Exclusion Criteria:

1. History of other malignant tumors within the past 5 years；
2. Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.
3. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 4 weeks before the first administration, diagnostic or surface surgery was performed within 1 week before the first administration, or elective surgery was expected during the trial.
4. The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.
5. Uncontrolled pleural, pericardial, or peritoneal effusions.
6. Severe cardiac diseases occurring within 6 months prior to the first dose.
7. Arterial/venous thrombosis within 6 months before the first dose.
8. Clinically significant bleeding symptoms or predisposition within 3 months prior to the first dose.
9. Active infection or fever of unknown origin \> 38.5 ° C was present within 4 weeks before the first administration of the study
10. History of immunodeficiency.
11. Active hepatitis B or C.
12. Diseases affecting drug absorption/transport (e.g., malabsorption syndromes).
13. A history of severe allergic reactions to HRS-6719 and its main components was known or suspected, or there was a history of delayed allergic reactions, eczema or asthma that could not be controlled by topical corticosteroids.
14. Use of strong CYP3A4/P-gp inhibitors/inducers within 5 half-lives before the first dose.
15. Adverse events (AEs) from prior anti-tumor therapy not resolved to CTCAE v5.0 ≤ Grade 1.
16. Patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or clinically significant pulmonary fibrosis, persistent pneumonia, pneumonia caused by drug or radiotherapy, congenital pneumonia, or chest CT scan found any evidence of active pneumonia.
17. Through medical history or CT examination, it was found that there was active pulmonary tuberculosis infection within 1 year before enrollment, or more than 1 year ago, there was a history of active pulmonary tuberculosis infection but no formal treatment.
18. Live attenuated vaccines administered within 4 weeks before the first dose or planned during the study.
19. Other factors potentially compromising study safety or data integrity.

Where it's running

• Barbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Shi Wei SUN
• Email: Shiwei.sun@hengrui.com
• Phone: 18036618554

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HLX316 first-in-human dose study in advanced/metastatic solid tumors

  A first-in-human, Phase 1 study tests HLX316 to see if it is safe and tolerable and to get early signs of how it behaves in the body and whether it shows any tumor-killing activity in adults with advanced solid tumors.

  Recruiting Phase 1 Shanghai Henlius Biotech · Chongqing and 4 other locations · NCT07541534

• HLX48 first-in-human safety study in advanced solid tumors

  This early-phase study tests HLX48 in adults with advanced/metastatic solid tumors to see if it is safe and how it behaves in the body.

  Recruiting at 2 sites Phase 1 Shanghai Henlius Biotech · North Ryde, New South Wales and 6 other locations · NCT07473726

• SYS6043 treatment for advanced or metastatic solid tumors

  We will test SYS6043, a B7‑H3‑targeted antibody‑drug conjugate, in adults with advanced or metastatic solid tumors who have progressed on or are intolerant of standard therapies.

  Recruiting Phase 1/2 CSPC Megalith Biopharmaceutical Co.,Ltd. · Beijing, Beijing Municipality · NCT07415863

• HLX37 treatment for advanced or metastatic solid tumors, including non-small cell lung cancer

  This trial tests HLX37, given alone or with chemotherapy, to see if it is safe and how the body handles it in adults with advanced or metastatic solid tumors including non-small cell lung cancer.

  Recruiting at 2 sites Early Phase 1 Shanghai Henlius Biotech · Shanghai and 1 other locations · NCT07274813

• DB-1317 for selected advanced or metastatic solid tumors

  This study will try DB-1317, given every three weeks, in adults with advanced or metastatic solid tumors that have progressed after standard treatments.

  Recruiting at 14 sites Phase 1 DualityBio Inc. · Los Angeles, California and 13 other locations · NCT07141706

• MHB088C treatment for adults with advanced solid tumors

  This study will test MHB088C to see if it is safe and shows early signs of benefit in adults with advanced or metastatic solid tumors.

  Recruiting Phase 1/2 Qilu Pharmaceutical Co., Ltd. · Beijing · NCT07102004

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.