A Study for HSK39775 in Participants With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I/II Study to Assess the Safety, Tolerability, PK/PD, and Preliminary Efficacy of HSK39775 Tablet Monotherapy in Participants With Advanced Solid Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314373
• Other study ID #: HSK39775-101/201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 7, 2024
• Est. completion date: September 1, 2028

Study information

• Verified date: March 2024
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: Yong Cao
• Phone: 028-67258840
• Email: caoyong[@]haisco.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 243
• Est. completion date: September 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• HSK39775 Monotherapy
HSK39775 will be administered orally once daily

Locations

Country	Name	City	State
China	Fundan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xizang Haisco Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE/SAE	Safety data	From time of informed consent to 28 days post last dose or start of other anti-cancer therapies
Primary	DLT	Safety data	From the start of first dose to the end of Cycle1(each cycle is 28 days)
Primary	MTD/MAD	Safety data	From the start of first dose to the end of Cycle1(each cycle is 28 days)
Secondary	Maximum Plasma Concentration [Cmax]		At predefined intervals throughout the treatment period(approximately 12 weeks)
Secondary	Area Under Curve[AUC]		At predefined intervals throughout the treatment period(approximately 12 weeks)
Secondary	Time to maximum observed concentration [Tmax]		At predefined intervals throughout the treatment period(approximately 12 weeks)
Secondary	Elimination half-life [t1/2]		At predefined intervals throughout the treatment period(approximately 12 weeks)
Secondary	Overall Response Rate (ORR) per RECIST V1.1		From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Secondary	Progression Free Survival		From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Secondary	Time To Response		From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Secondary	Disease Control Rate		From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Secondary	Best percentage change in target lesion		From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]