A Study for HSK39775 in Participants With Solid Tumors

Haisco Pharmaceutical Group

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: HSK39775 Monotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06314373

HSK39775-101/201

Details and patient eligibility

About

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

Enrollment: 243 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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243 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

Dose Escalation:Participants will receive escalating doses of HSK39775

Treatment:

Drug: HSK39775 Monotherapy

Cohort Expansion

Experimental group

Description:

Cohort Expansion:Participants will receive HSK39775 at the identified RP2D

Treatment:

Drug: HSK39775 Monotherapy