A Study for HSK39775 in Participants With Solid Tumors

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HSK39775 Monotherapy

• Study Type: Interventional
• Enrollment (Estimated): 243
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yong Cao; Phone Number: 028-67258840; Email: caoyong@haisco.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fundan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation; Dose Escalation:Participants will receive escalating doses of HSK39775	Drug: HSK39775 Monotherapy; HSK39775 will be administered orally once daily
Experimental: Cohort Expansion; Cohort Expansion:Participants will receive HSK39775 at the identified RP2D	Drug: HSK39775 Monotherapy; HSK39775 will be administered orally once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xizang Haisco Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HSK39775-101/201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No