A Study for HSK39775 in Participants With Solid Tumors

NCT ID: NCT06314373

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2028-09-01

Brief Summary

This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

Dose Escalation:Participants will receive escalating doses of HSK39775

Group Type: EXPERIMENTAL

HSK39775 Monotherapy

Intervention Type: DRUG

HSK39775 will be administered orally once daily

Cohort Expansion

Cohort Expansion:Participants will receive HSK39775 at the identified RP2D

Group Type: EXPERIMENTAL

HSK39775 Monotherapy

Intervention Type: DRUG

HSK39775 will be administered orally once daily

Interventions

HSK39775 Monotherapy

HSK39775 will be administered orally once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older at screening

2. Histological or cytological confirmation of advanced malignancy, have failed or intolerant to the standard-of-care treatment or no standard therapy is recognized or standard therapy is unavailable

3. Eastern Cooperative Oncology Group performance status 0 or 1

4. Patients must have evaluable disease as defined

5. Life expectancy of ≥ 12 weeks

6. Adequate organ and bone marrow function per protocol

7. Female patients who are women of childbearing potential with confirmed of a negative pregnancy test within 7 days prior to the first dose and agreement to the use of effective contraceptive method at the same time during study treatment period and for up to 6 months after the last dose of study treatment. Male patients must be willing to use effective contraception during the study treatment period and for up to 6 months after the last dose of study treatment

8. Written informed consent must be obtained

Exclusion Criteria

1. Known allergies to HSK39775 or its excipients

2. Prior anticancer treatment is ineligible per protocol

3. Subjects who have had continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent within 4 weeks prior to the first dose of study treatment

4. Subjects who have had live vaccine within 4 weeks prior the first dose of study treatment

5. Currently participating in a study of another investigational agent or device

6. Subjects who have had received another agent with same target

7. Subjects who have not recovered (to grade ≤1 or baseline) from toxicities related to prior therapies

8. Subjects who have had received drugs that may have drug-drug interaction potential within 4 weeks or 5 half-lives prior to the first dose of study treatment

9. Subjects who have had received major surgery within 4 weeks prior the first dose of study treatment

10. Central nervous system metastases associated with neurological symptoms

11. Active hepatitis B or hepatitis C infection

12. A history of immunodeficiency

13. Clinically relevant cardiovascular disease as delined by protocol

14. Inability to swallow the formulated product or impairment of GI function or disease that may significantly alter the absorption of study drug

15. A female patient who is pregnant or lactating

16. Other conditions, in investigator's opinion, not suitable to participate in the clinical study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xizang Haisco Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fundan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yong Cao

Role: CONTACT

caoyong@haisco.com

028-67258840

Other Identifiers

HSK39775-101/201

Identifier Type: -

Identifier Source: org_study_id