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Trial Title:
A Study for HSK39775 in Participants With Solid Tumors
NCT ID:
NCT06314373
Condition:
Advanced Solid Tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HSK39775 Monotherapy
Description:
HSK39775 will be administered orally once daily
Arm group label:
Cohort Expansion
Arm group label:
Dose Escalation
Summary:
This research is designed to determine if HSK39775 is safe, tolerable, and has
anti-cancer activity in patients with advanced solid tumors.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fundan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Start date:
March 7, 2024
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Xizang Haisco Pharmaceutical Co., Ltd
Agency class:
Industry
Source:
Haisco Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06314373