A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors

NCT06922357 | Recruiting Phase 1

• 1 other identifier: HRS-6719-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.

Conditions

Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Dose Limited Toxicity (DLT)

  21 Days (first cycle)

• Maximum tolerable dose (MTD)

  21 Days (first cycle)

• Recommended dose for phase II (RP2D)

  through phase I completion, an average of 1 years

• Incidence and severity of AE

  from Day1 to 30 days after last dose

Secondary Outcomes (7)

• Relative bioavailability after meals on an empty stomach

  through phase I completion, an average of 1 years

• ORR

  12 months after the last subject was enrolled in the group

• DOR

  12 months after the last subject was enrolled in the group

• DCR

  12 months after the last subject was enrolled in the group

• TTR

  12 months after the last subject was enrolled in the group

Study Arms (1)

HRS-6719

EXPERIMENTAL

Drug: HRS-6719

Interventions

HRS-6719 DRUG

HRS-6719

HRS-6719

Eligibility Criteria

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

You may qualify if:

• Subjects must voluntarily participate in the study and sign an informed consent form;
• Aged 18-75 years, male or female eligible；
• ECOG performance status score of 0-1；
• Expected survival ≥12 weeks；
• 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；
• Ability to provide sufficient fresh or archived tumor tissue specimens；
• Adequate function of vital organs；
• 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。

You may not qualify if:

• History of other malignant tumors within the past 5 years；
• Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.
• 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.
• The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.
• Uncontrolled pleural, pericardial, or peritoneal effusions.
• Severe cardiac diseases occurring within 6 months prior to the first dose.
• Arterial/venous thrombosis within 6 months before the first dose.
• Clinically significant bleeding symptoms or predisposition within 3 months prior to the first dose.
• Active infection or fever of unknown origin \> 38.5 ° C was present within 4 weeks before the first administration of the study
• History of immunodeficiency.
• Active hepatitis B or C.
• Diseases affecting drug absorption/transport (e.g., malabsorption syndromes).
• 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.
• Use of strong CYP3A4/P-gp inhibitors/inducers within 5 half-lives before the first dose.
• Adverse events (AEs) from prior anti-tumor therapy not resolved to CTCAE v5.0 ≤ Grade 1.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Shi Wei SUN

CONTACT

18036618554; Shiwei.sun@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-04

Locations

CN (1)