Clinical trial · Interventional
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
NCT06314373CI-TRIAL-00075119recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSK39775 Monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Dose Escalation:Participants will receive escalating doses of HSK39775
- interventionNames
- Drug: HSK39775 Monotherapy
- type
- EXPERIMENTAL
- label
- Cohort Expansion
- description
- Cohort Expansion:Participants will receive HSK39775 at the identified RP2D
- interventionNames
- Drug: HSK39775 Monotherapy
Primary outcomes (3)
- measure
- AE/SAE
- timeFrame
- From time of informed consent to 28 days post last dose or start of other anti-cancer therapies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.