A Study for HSK39775 in Participants With Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HSK39775 Monotherapy

• Registration Number: NCT06314373
• Lead Sponsor: Xizang Haisco Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-29
• Status Verified: 2024-03
• Study Start: 2024-03-07
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Primary Completion: 2028-02-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Escalation	HSK39775 Monotherapy	Dose Escalation:Participants will receive escalating doses of HSK39775
Cohort Expansion	HSK39775 Monotherapy	Cohort Expansion:Participants will receive HSK39775 at the identified RP2D

Primary Outcome Measures

Name	Time	Method
DLT	From the start of first dose to the end of Cycle1(each cycle is 28 days)	Safety data
MTD/MAD	From the start of first dose to the end of Cycle1(each cycle is 28 days)	Safety data
AE/SAE	From time of informed consent to 28 days post last dose or start of other anti-cancer therapies	Safety data

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration [Cmax]	At predefined intervals throughout the treatment period(approximately 12 weeks)
Time to maximum observed concentration [Tmax]	At predefined intervals throughout the treatment period(approximately 12 weeks)
Time To Response	From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Elimination half-life [t1/2]	At predefined intervals throughout the treatment period(approximately 12 weeks)
Progression Free Survival	From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
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]
Area Under Curve[AUC]	At predefined intervals throughout the treatment period(approximately 12 weeks)
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]
Disease Control Rate	From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]

Trial Locations

Locations (1)

Fundan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China