Recruiting NCT06314373
A Study for HSK39775 in Participants With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK39775 Monotherapy.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Interventions
- Drug HSK39775 Monotherapy
HSK39775 will be administered orally once daily
Primary outcome measures
- AE/SAE [Time frame: From time of informed consent to 28 days post last dose or start of other anti-cancer therapies]
- DLT [Time frame: From the start of first dose to the end of Cycle1(each cycle is 28 days)]
- MTD/MAD [Time frame: From the start of first dose to the end of Cycle1(each cycle is 28 days)]
Secondary outcome measures (9)
- Maximum Plasma Concentration [Cmax] [Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)]
- Area Under Curve[AUC] [Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)]
- Time to maximum observed concentration [Tmax] [Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)]
- Elimination half-life [t1/2] [Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)]
- Overall Response Rate (ORR) per RECIST V1.1 [Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
- Progression Free Survival [Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
- Time To Response [Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
- Disease Control Rate [Time frame: 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 [Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
Eligibility criteria
Inclusion criteria
- Age 18 years or older at screening
- 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
- Eastern Cooperative Oncology Group performance status 0 or 1
- Patients must have evaluable disease as defined
- Life expectancy of ≥ 12 weeks
- Adequate organ and bone marrow function per protocol
- 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
- Written informed consent must be obtained
Exclusion criteria
- Known allergies to HSK39775 or its excipients
- Prior anticancer treatment is ineligible per protocol
- 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
- Subjects who have had live vaccine within 4 weeks prior the first dose of study treatment
- Currently participating in a study of another investigational agent or device
- Subjects who have had received another agent with same target
- Subjects who have not recovered (to grade ≤1 or baseline) from toxicities related to prior therapies
- 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
- Subjects who have had received major surgery within 4 weeks prior the first dose of study treatment
- Central nervous system metastases associated with neurological symptoms
- Active hepatitis B or hepatitis C infection
- A history of immunodeficiency
- Clinically relevant cardiovascular disease as delined by protocol
- Inability to swallow the formulated product or impairment of GI function or disease that may significantly alter the absorption of study drug
- A female patient who is pregnant or lactating
- Other conditions, in investigator's opinion, not suitable to participate in the clinical study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fundan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06314373 · HSK39775-101/201